Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health (AMPLIFY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000880
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : February 25, 2022
Sponsor:
Collaborators:
University of Tennessee Health Science Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham

Brief Summary:
This research study will test the efficacy of interactive, web-based interventions that improve diet, physical activity and weight management changes among early stage survivors of breast, prostate, colorectal, endometrial, renal, thyroid, and ovarian cancers, as well as multiple myeloma and non-Hodgkin Lymphoma. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Endometrial Cancer Kidney Cancer Multiple Myeloma Ovary Cancer Prostate Cancer Thyroid Cancer Non-Hodgkin Lymphoma Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health Other: Diet-Exercise Other: Exercise-Diet Other: Survivorship Topics - Combined Diet and Exercise Not Applicable

Detailed Description:

For this web-based behavioral intervention trial aimed at improving lifestyle behaviors of individuals at higher risk for cancer, other comorbidities and functional decline, 652 cancer survivors (a large proportion of whom will be age 65 or over, rural, and of minority status) will be enrolled and randomly assigned to one of the following study arms: 1) A diet and exercise intervention which would begin immediately, with the first 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, and the second 6 months focused on increasing physical activity. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; 2) An exercise and diet intervention which would begin immediately, with the first 6 months focused on increasing physical activity, and the second 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; and 3) A 12-month combined diet and exercise intervention focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, while at the same time promoting physical activity. The 326 cancer survivors assigned to this arm would receive the intervention after a 6-month delay and will be evaluated at baseline, 6-, 12-, 18- and 24-months. Weight status, waist circumference, body composition, diet quality, physical activity, physical performance, quality of life, comorbidity, and health utilities will be measured at baseline and each follow-up time point, as will mediators of behavior change, e.g., social support, self-efficacy and barriers. Additionally, dried blood spots obtained from fingersticks will be analyzed for cytokines (IL-6 and hsCRP) and biomarkers of gluco- and lipid regulation, i.e., glucose, and blood lipids (TG) and insulin.

It is hypothesized that cancer survivors assigned to all three of these study arm will experience significant improvements in weight status, body composition, diet quality, physical activity, physical performance, and quality of life. These improvements also will translate into lower health utility scores and prove cost effective. It also is anticipated that analyses will uncover significant mediators, such as self-efficacy, and moderators, such as level of educational attainment associated with program efficacy. Finally, we hypothesize that while all study arms will experience significant benefit, the sequenced arm participants (arms 1 and 2) will have significantly greater odds of achieving improved diet quality, weight loss, and moderate intensity aerobic physical activity of at least 150 minutes a week as measured by accelerometer) post-intervention than survivors randomized to the simultaneous arm.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 652 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will participate in one of three arms:

  1. Diet followed by Exercise intervention
  2. Exercise followed by Diet intervention
  3. Survivorship Topics followed by Combined Diet and Exercise intervention
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Single blinded trial in which the study participant and select individuals in the research team (i.e., interventionists) will be aware of randomization status, but the assessors and investigators will not.
Primary Purpose: Supportive Care
Official Title: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024


Arm Intervention/treatment
Experimental: Project 1: Diet-Exercise
Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
Other Name: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health

Other: Survivorship Topics - Combined Diet and Exercise
Survivorship Topics - Combined Diet and Exercise

Experimental: Project 2: Exercise-Diet
Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
Other Name: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health

Other: Survivorship Topics - Combined Diet and Exercise
Survivorship Topics - Combined Diet and Exercise

Experimental: Project 3: Survivorship Topics- Combined Diet and Exercise
For the first six months of the study, participants will be in the Survivorship Topics group, where they receive health information on topics other than diet and exercise. Participants will then join the intervention, receiving the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
Other Name: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health

Other: Diet-Exercise
Diet-Exercise

Other: Exercise-Diet
Exercise-Diet




Primary Outcome Measures :
  1. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: Baseline ]
    Participants will complete two dietary recalls (one weekday and one weekend day)

  2. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 6 months ]
    Participants will complete two dietary recalls (one weekday and one weekend day)

  3. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 12 months ]
    Participants will complete two dietary recalls (one weekday and one weekend day)

  4. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 18 months ]
    Participants will complete two dietary recalls (one weekday and one weekend day)

  5. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 24 months ]
    Participants will complete two dietary recalls (one weekday and one weekend day)

  6. Change in body weight [ Time Frame: Baseline ]
    Participant body weight will be measured during an in-person or remote (Zoom) visit

  7. Change in body weight [ Time Frame: 6 months ]
    Participant body weight will be measured during an in-person or remote (Zoom) visit

  8. Change in body weight [ Time Frame: 12 months ]
    Participant body weight will be measured during an in-person or remote (Zoom) visit

  9. Change in body weight [ Time Frame: 18 months ]
    Participant body weight will be measured during an in-person or remote (Zoom) visit

  10. Change in body weight [ Time Frame: 24 months ]
    Participant body weight will be measured during an in-person or remote (Zoom) visit

  11. Change in physical activity and sleep (Measured by actigraphy) [ Time Frame: Baseline ]
    Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.

  12. Change in physical activity and sleep (Measured by actigraphy) [ Time Frame: 6 months ]
    Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.

  13. Change in physical activity and sleep (Measured by actigraphy) [ Time Frame: 12 months ]
    Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.

  14. Change in physical activity and sleep (Measured by actigraphy) [ Time Frame: 18 months ]
    Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.

  15. Change in physical activity and sleep (Measured by actigraphy) [ Time Frame: 24 months ]
    Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.


Secondary Outcome Measures :
  1. Change in waist circumference [ Time Frame: Baseline ]
    Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.

  2. Change in waist circumference [ Time Frame: 6 months ]
    Waist circumference will be measured using an unmarked tape at the level of the umbilicus during the in-person or remote assessments.

  3. Change in waist circumference [ Time Frame: 12 months ]
    Waist circumference will be measured using an unmarked tape at the level of the umbilicus during in-person or remote assessments.

  4. Change in waist circumference [ Time Frame: 18 months ]
    Waist circumference will be measured using an marked tape at the level of the umbilicus during the in-person or remote assessments.

  5. Change in waist circumference [ Time Frame: 24 months ]
    Waist circumference will be measured using an unmarked tape at the level of the umbilicus during the in-person or remote assessments.

  6. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: Baseline ]
    To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day

  7. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 6 months ]
    To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day

  8. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 12 months ]
    To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day

  9. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 18 months ]
    To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day

  10. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 24 months ]
    To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day

  11. Change in physical performance [ Time Frame: Baseline ]
    Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  12. Change in physical performance [ Time Frame: 6 Months ]
    Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  13. Change in physical performance [ Time Frame: 12 months ]
    Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  14. Change in physical performance [ Time Frame: 18 months ]
    Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  15. Change in physical performance [ Time Frame: 24 months ]
    Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  16. Change in physical activity (Patient reported outcome) [ Time Frame: Baseline ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  17. Change in physical activity (Patient reported outcome) [ Time Frame: 3 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  18. Change in physical activity (Patient reported outcome) [ Time Frame: 6 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  19. Change in physical activity (Patient reported outcome) [ Time Frame: 9 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  20. Change in physical activity (Patient reported outcome) [ Time Frame: 12 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  21. Change in physical activity (Patient reported outcome) [ Time Frame: 15 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  22. Change in physical activity (Patient reported outcome) [ Time Frame: 18 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  23. Change in physical activity (Patient reported outcome) [ Time Frame: 21 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  24. Change in physical activity (Patient reported outcome) [ Time Frame: 24 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

  25. Change in quality of life (Patient reported outcome) [ Time Frame: Baseline ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  26. Change in quality of life (Patient reported outcome) [ Time Frame: 3 Months ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  27. Change in quality of life (Patient reported outcome) [ Time Frame: 6 Months ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  28. Change in quality of life (Patient reported outcome) [ Time Frame: 9 Months ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  29. Change in quality of life (Patient reported outcome) [ Time Frame: 12 months ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  30. Change in quality of life (Patient reported outcome) [ Time Frame: 15 months ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  31. Change in quality of life (Patient reported outcome) [ Time Frame: 18 months ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  32. Change in quality of life (Patient reported outcome) [ Time Frame: 21 months ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  33. Change in quality of life (Patient reported outcome) [ Time Frame: 24 months ]
    Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

  34. Change in healthcare utilization (Patient reported outcome) [ Time Frame: Baseline ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

  35. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 3 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

  36. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 6 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

  37. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 9 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

  38. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 12 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

  39. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 15 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

  40. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 18 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

  41. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 21 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

  42. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 24 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.


Other Outcome Measures:
  1. Change in Levels of Stress (Patient reported outcome) [ Time Frame: baseline ]
    Participants will complete the 14-item Perceived Stress Scale

  2. Change in Levels of Stress (Patient reported outcome) [ Time Frame: 6 months ]
    Participants will complete the 14-item Perceived Stress Scale

  3. Change in Levels of Stress (Patient reported outcome) [ Time Frame: 12 months ]
    Participants will complete the 14-item Perceived Stress Scale

  4. Change in Levels of Stress (Patient reported outcome) [ Time Frame: 18 months ]
    Participants will complete the 14-item Perceived Stress Scale

  5. Change in Levels of Stress (Patient reported outcome) [ Time Frame: 24 months ]
    Participants will complete the 14-item Perceived Stress Scale

  6. Change in CIrculating Biomarkers [ Time Frame: baseline ]
    Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha

  7. Change in CIrculating Biomarkers [ Time Frame: 6 months ]
    Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha

  8. Change in CIrculating Biomarkers [ Time Frame: 12 months ]
    Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha

  9. Change in CIrculating Biomarkers [ Time Frame: 18 months ]
    Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha

  10. Change in CIrculating Biomarkers [ Time Frame: 24 months ]
    Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha

  11. Change in Comorbidity and Symptoms (Patient reported outcome) [ Time Frame: baseline ]
    The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered

  12. Change in Comorbidity and Symptoms (Patient reported outcome) [ Time Frame: 6 months ]
    The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered

  13. Change in Comorbidity and Symptoms (Patient reported outcome) [ Time Frame: 12 months ]
    The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered

  14. Change in Comorbidity and Symptoms (Patient reported outcome) [ Time Frame: 18 months ]
    The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered

  15. Change in Comorbidity and Symptoms (Patient reported outcome) [ Time Frame: 24 months ]
    The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered

  16. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [ Time Frame: baseline ]
    Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al

  17. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [ Time Frame: 6 months ]
    Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al

  18. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [ Time Frame: 12 months ]
    Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al

  19. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [ Time Frame: 18 months ]
    Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al

  20. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [ Time Frame: 24 months ]
    Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al

  21. Quality of Life, EQ-5D-5L [ Time Frame: baseline ]
    comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression

  22. Quality of Life, EQ-5D-5L [ Time Frame: 6 months ]
    comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression

  23. Quality of Life, EQ-5D-5L [ Time Frame: 18 months ]
    comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression

  24. Quality of Life, EQ-5D-5L [ Time Frame: 24 months ]
    comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression

  25. Health literacy and Ehealth literacy scales (eHEALS) [ Time Frame: baseline ]
    The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006

  26. Health literacy and Ehealth literacy scales (eHEALS) [ Time Frame: 6 months ]
    The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006

  27. Health literacy and Ehealth literacy scales (eHEALS) [ Time Frame: 12 months ]
    The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006

  28. Health literacy and Ehealth literacy scales (eHEALS) [ Time Frame: 18 months ]
    The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006

  29. Health literacy and Ehealth literacy scales (eHEALS) [ Time Frame: 24 months ]
    The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006

  30. Health related status [ Time Frame: baseline ]
    Questions include: smoking status, falls, serious health events

  31. Health related status [ Time Frame: 6 months ]
    Questions include: smoking status, falls, serious health events

  32. Health related status [ Time Frame: 12 months ]
    Questions include: smoking status, falls, serious health events

  33. Health related status [ Time Frame: 18 months ]
    Questions include: smoking status, falls, serious health events

  34. Health related status [ Time Frame: 24 months ]
    Questions include: smoking status, falls, serious health events

  35. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [ Time Frame: baseline ]
    Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning

  36. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [ Time Frame: 6 months ]
    Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning

  37. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [ Time Frame: 12 months ]
    Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning

  38. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [ Time Frame: 18 months ]
    Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning

  39. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [ Time Frame: 24 months ]
    Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50 years or older
  • Resident of the continental United States
  • Diagnosed with multiple myeloma, non-Hodgkin lymphoma, or localized kidney or ovarian cancer; or [localized (includes in situ) through regional] breast, colorectum, endometrium, thyroid, or prostate cancer.
  • Completed primary treatment (surgery, radiation or chemotherapy). Active surveillance among men with prostate cancer or women with ductal carcinoma in situ is acceptable.
  • Completion of the 8th grade of school. Able to read and write English.
  • Normal blood pressure or those with high blood pressure for whom physician permission was granted.
  • Community dwelling.
  • Reside in an area that receives wireless coverage.
  • Have an active email address or be willing to have one created for the study.
  • Current body mass index of greater than or equal to 25 kg/m2, but less than 50 kg/m2.
  • Current physical activity level is less than 150 minutes of moderate-to-vigorous exercise per week.

Exclusion Criteria:

  • Participation in another diet and exercise program.
  • Evidence of progressive cancer of the eligible types.
  • Recurrence of the eligible cancer types (exceptions are biochemical recurrence of prostate cancer).
  • A physician has provided instruction to limit current physical activity.
  • Pre-existing medical conditions that preclude adherence to an unsupervised weight loss intervention (e.g., pregnancy, severe orthopedic conditions, impending hip or knee replacement (within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of heart attack, congestive heart failure or pulmonary conditions that required oxygen or hospitalization within 6 months).
  • Second primary cancers, with the exception of non-melanoma skin cancer, or if the initial and second cancers are both deemed eligible cancers.
  • Reside in a skilled nursing or assisted living facility.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000880


Contacts
Layout table for location contacts
Contact: Wendy Demark-Wahnefried, PhD, RD 833-535-7934 AMPLIFY@UABMC.EDU

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Wendy Demark-Wahnefried, PhD, RD    833-535-7934    AMPLIFY@UAMBC.EDU   
Sub-Investigator: Kevin Fontaine, PhD         
Sub-Investigator: Dorothy Pekmezi, PhD         
Sub-Investigator: Laura Rogers, MD         
Sub-Investigator: Maria Pisu, PhD         
Sub-Investigator: Yu-Mei Schoenberger, PhD         
Sub-Investigator: Kelly Kenzik, PhD         
Sub-Investigator: Robert Oster, PhD         
Sub-Investigator: Nataliya Ivankova, PhD         
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: Michelle Martin, PhD    901-448-2383    mmart126@uthsc.edu   
Contact: Dana Guerrero, BS    (901) 448-3174    dguerre2@uthsc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
University of Tennessee Health Science Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Wendy Demark-Wahnefried, PhD, RD University of Alabama at Birmingham
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Wendy Demark-Wahnefried, PhD, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04000880    
Other Study ID Numbers: IRB-300002068
1P01CA229997 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We agree to share any remaining biospecimens, including plasma, sera, and buffy coat (some stored in RNAlater® and some stored alone). Samples will be accompanied by a limited dataset of deidentified participant data that investigators need for analyses. To facilitate the data sharing, we plan to build a central archive that will allow public access to data dictionaries and limited-access anonymized datasets. We will develop a single password protected Share Point web system so that all data dictionaries, documentation, and data accessibility will have a consistent user interface. All datasets will conform to the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). Data will be made available as either a SAS export dataset, or as a tab-delimited ASCII file.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data and samples will be made available to outside investigators after all aims of the P01 and all primary outcomes papers have been published (consonant with the NIH definition of "timely fashion." Requests for data or biologic samples will be handled on a case-by-case basis, and in consultation with the P01 principal investigators (Dr. Demark-Wahnefried) and other members of the investigative team.
Access Criteria: Requests for data or biologic samples will be handled on a case-by-case basis, and in consultation with the P01 principal investigators (Dr. Demark-Wahnefried) and other members of the investigative team. Individuals in receipt of data and samples must produce proof of human subjects and HIPAA training. For the transfer of biospecimens, Human Materials and Data Transfer Agreements will be established between UAB and the requesting institution. Publications resulting from the transfer of samples or data must credit the P01 grant. For data only, requesting users will be required to sign a data-use sharing agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham:
Cancer survivor
Lifestyle behaviors
Web-based intervention
Diet
Exercise
Weight Control
Physical Activity
Distance Medicine
Rural
Older
Minority
African American
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Endometrial Neoplasms
Thyroid Neoplasms
Kidney Neoplasms
Ovarian Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Urologic Neoplasms
Kidney Diseases
Urologic Diseases