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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 : June 21, 2021
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, and ovarian cancers. 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 Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health Other: Diet-Exercise Other: Exercise-Diet Other: Wait-list Control- 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, phlebotomy will be performed and biospecimens stored for future analysis.

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.

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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. Wait-list control 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 : July 1, 2024
Estimated Study Completion Date : July 1, 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: Wait-list Control- Combined Diet and Exercise
Wait-list Control- 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: Wait-list Control- Combined Diet and Exercise
Wait-list Control- Combined Diet and Exercise

Experimental: Project 3: Wait-list Control- Combined Diet and Exercise
For the first six months of the study, participants will be in the wait-list control 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 the NCI-developed ASA24.

  2. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 6 months ]
    Participants will complete the NCI-developed ASA24.

  3. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 12 months ]
    Participants will complete the NCI-developed ASA24.

  4. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 18 months ]
    Participants will complete the NCI-developed ASA24.

  5. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 24 months ]
    Participants will complete the NCI-developed ASA24.

  6. Change in dietary quality and intake (Patient reported outcome). [ Time Frame: 30 months ]
    Participants will complete the NCI-developed ASA24.

  7. Change in body weight (Measured by study staff) [ Time Frame: Baseline ]
    Participant body weight will be measured during an in-person visit with a digital scale.

  8. Change in body weight (Measured by study staff) [ Time Frame: 6 months ]
    Participant body weight will be measured during an in-person visit with a digital scale.

  9. Change in body weight (Measured by study staff) [ Time Frame: 12 months ]
    Participant body weight will be measured during an in-person visit with a digital scale.

  10. Change in body weight (Measured by study staff) [ Time Frame: 18 months ]
    Participant body weight will be measured during an in-person visit with a digital scale.

  11. Change in body weight (Measured by study staff) [ Time Frame: 24 months ]
    Participant body weight will be measured during an in-person visit with a digital scale.

  12. Change in body weight (Measured by study staff) [ Time Frame: 30 months ]
    Participant body weight will be measured during an in-person visit with a digital scale.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Change in physical activity and sleep (Measured by actigraphy) [ Time Frame: 30 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 (Measured by study staff) [ Time Frame: Baseline ]
    Waist circumference will be measured using a measuring tape at the level of the umbilicus during the in-person assessments.

  2. Change in waist circumference (Measured by study staff) [ Time Frame: 6 months ]
    Waist circumference will be measured using a measuring tape at the level of the umbilicus during the in-person assessments.

  3. Change in waist circumference (Measured by study staff) [ Time Frame: 12 months ]
    Waist circumference will be measured using a measuring tape at the level of the umbilicus during the in-person assessments.

  4. Change in waist circumference (Measured by study staff) [ Time Frame: 18 months ]
    Waist circumference will be measured using a measuring tape at the level of the umbilicus during the in-person assessments.

  5. Change in waist circumference (Measured by study staff) [ Time Frame: 24 months ]
    Waist circumference will be measured using a measuring tape at the level of the umbilicus during the in-person assessments.

  6. Change in waist circumference (Measured by study staff) [ Time Frame: 30 months ]
    Waist circumference will be measured using a measuring tape at the level of the umbilicus during the in-person assessments.

  7. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: Baseline ]
    To assess muscle mass, three days prior to the home assessment 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.

  8. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 6 months ]
    To assess muscle mass, three days prior to the home assessment 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.

  9. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 12 months ]
    To assess muscle mass, three days prior to the home assessment 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.

  10. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 18 months ]
    To assess muscle mass, three days prior to the home assessment 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.

  11. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 24 months ]
    To assess muscle mass, three days prior to the home assessment 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.

  12. Change in muscle mass (Measured by the D3 creatine dilution method) [ Time Frame: 30 months ]
    To assess muscle mass, three days prior to the home assessment 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.

  13. Change in physical performance (Measured by study staff) [ Time Frame: Baseline ]
    Participants will complete the Senior Fitness Battery during the in-person assessments, which includes chair stands, 3m walk, sit-to-stand, reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  14. Change in physical performance (Measured by study staff) [ Time Frame: 6 Months ]
    Participants will complete the Senior Fitness Battery during the in-person assessments, which includes chair stands, 3m walk, sit-to-stand, reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  15. Change in physical performance (Measured by study staff) [ Time Frame: 12 months ]
    Participants will complete the Senior Fitness Battery during the in-person assessments, which includes chair stands, 3m walk, sit-to-stand, reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  16. Change in physical performance (Measured by study staff) [ Time Frame: 18 months ]
    Participants will complete the Senior Fitness Battery during the in-person assessments, which includes chair stands, 3m walk, sit-to-stand, reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  17. Change in physical performance (Measured by study staff) [ Time Frame: 24 months ]
    Participants will complete the Senior Fitness Battery during the in-person assessments, which includes chair stands, 3m walk, sit-to-stand, reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  18. Change in physical performance (Measured by study staff) [ Time Frame: 30 months ]
    Participants will complete the Senior Fitness Battery during the in-person assessments, which includes chair stands, 3m walk, sit-to-stand, reaching (stretching exercises of the arms and legs, and the 2-minute step test.

  19. Change in physical activity (Patient reported outcome) [ Time Frame: Baseline ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Exercise Questionnaire).

  20. 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 Exercise Questionnaire).

  21. 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 Exercise Questionnaire).

  22. 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 Exercise Questionnaire).

  23. 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 Exercise Questionnaire).

  24. 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 Exercise Questionnaire).

  25. 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 Exercise Questionnaire).

  26. 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 Exercise Questionnaire).

  27. 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 Exercise Questionnaire).

  28. Change in physical activity (Patient reported outcome) [ Time Frame: 30 months ]
    Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Exercise Questionnaire).

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

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

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. Change in healthcare utilization (Patient reported outcome) [ Time Frame: 30 months ]
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.



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.


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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 Alabama, Mississippi, North Carolina, or Tennessee in the United States
  • Diagnosed with multiple myeloma or localized kidney or ovarian cancer; or [localized (includes in situ) through regional] breast, colorectum, endometrium, 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.
  • Higher risk for functional decline, such that self reported health "now limits them" to some degree in either "climbing several flights of stairs" or "walking more than a mile".
  • 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
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Contact: Wendy Demark-Wahnefried, PhD, RD 833-535-7934 AMPLIFY@UABMC.EDU

Locations
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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
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Principal Investigator: Wendy Demark-Wahnefried, PhD, RD University of Alabama at Birmingham
Additional Information:
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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: June 21, 2021
Last Verified: October 2020
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.

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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:
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Multiple Myeloma
Endometrial 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
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders