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Daughters, dUdes, Mothers and othErs Fighting Cancer Together (DUET)

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ClinicalTrials.gov Identifier: NCT04132219
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham

Brief Summary:
The purpose of this protocol is to conduct a 2-arm, single-blinded randomized controlled clinical trial (RCT) in which 56 dyads (defined as consisting of an overweight or obese cancer survivor of an obesity-related cancer and an overweight or obese "buddy" of his or her choosing) would be assigned either to a 6-month, diet- and exercise-based weight loss intervention delivered via an interactive website with tailored text messages, or to a 6-month wait-listed control group. The overall goals of the eHealth intervention are to reduce obesity and select circulating biomarkers (tumor necrosis factor alpha [TNFα], insulin, and insulin-like growth factor-1 [IGF-1]), as well as improve diet quality, physical activity, health-related quality of life (QoL), physical functioning and performance as compared to the control over the 6-month study period.

Condition or disease Intervention/treatment Phase
Cancer Overweight and Obesity Behavioral: eHealth Intervention Not Applicable

Detailed Description:

The specific aims of this protocol are to: 1) determine whether dyads (comprised of an overweight / obese cancer survivor and an overweight / obese buddy of his or her choosing) lose significantly more weight (kg) at 6-months when assigned to the eHealth intervention compared to a wait-listed control; 2) explore between-arm differences in score changes between baseline and 6-month follow-up for other key outcomes including measures of adiposity (e.g., waist circumference [WC] and body mass index [BMI]), blood pressure, diet quality, physical activity, health-related Quality of Life (QoL), physical functioning and performance; 3) Assess the impact of the intervention on select biomarkers associated with cancer risk and progression, e.g., tumor TNFα, insulin and IGF-1; and, 4) identify predictor variables associated with program efficacy, e.g., social support, self-efficacy, risk for depression, and dyad partner (spouse, relative, friend/neighbor).

Cancer survivors and their selected "buddies" who are interested in participating will be directed to a website that describes this study in detail. If interested, they will be asked to complete an online screener requiring information on race/ethnicity, gender, state of residence and eligibility criteria. Once interested participants are assessed for eligibility, consented and enrolled, they will be asked to complete online questionnaires that assess physical activity, dietary intake, health-related quality of life, risk for depression, self-efficacy, social support and barriers to diet resources. Finally, anthropometric measures, blood pressure, physical performance and circulating biomarkers will be collected in participants' homes by visiting study staff (whom the project manager will deploy after checking for a mutually convenient time for the 2-person dyad.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We anticipate enrolling 56 dyads of participants (2 per dyad). Each dyad will be randomized to either receive the intervention for 6 months or be placed on a 6-month waitlist and offered the opportunity to try the online intervention after final assessments are completed.
Masking: Single (Outcomes Assessor)
Masking Description: Assessors of anthropometric, physical function, patient reported outcomes and biospecimens are blinded to arm status
Primary Purpose: Prevention
Official Title: Daughters, (dUdes), Mothers and othErs Fighting Cancer Together
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Immediate Intervention Group
Dyads randomized to the Immediate Intervention Group will receive a "Welcome Box" at completion of the baseline assessment. The Welcome Box will include two of each of the following: 1) Letters describing the project logistics and the important roles of each dyad member); 2) WiFi-enabled Scales (with instructions to weigh daily); 3) Portion Doctor ®Tableware (with instructions to use the portion plates at least once a day); 4) Fitbit® Inspire Activity Monitors (with instructions to share data with the dyad member and the study office); and 5) Instructions on how to create a secured account on the DUET website and instructions for logging on.
Behavioral: eHealth Intervention
Every week, each dyad member will receive a tailored text message that provides a new fun fact or that encourages them to log-on to the website to access findings of new research and how the results might apply to them. They will be directed to specific pages in the Web-based program and asked to select strategies from a list that they will practice during the upcoming week. Graphic displays of their progress will be provided along with SCT-based feedback. They will be directed to the website to record their behavioral goals for the upcoming week. Tips also will be provided for effective communication to enhance couple efficacy. All usage will be tracked to assess adherence.

Delayed Intervention Group
Participants assigned to the Delayed Intervention Group will receive a "Welcome Box" which on the outside is identical (and also is comparably weighted with bottled water) to that given to the Immediate Intervention group. This box would include: 1) Letters describing the project logistics and the important roles of each dyad member; and 2) monthly online study newsletters on topics unrelated to diet and exercise, but still of interest to cancer survivors and dyad members such as coping with stress, reducing exposure to radiation, sun safety, etc. to enhance retention and will be offered the opportunity to receive the online intervention after completing final 6-month assessments.
Behavioral: eHealth Intervention
Every week, each dyad member will receive a tailored text message that provides a new fun fact or that encourages them to log-on to the website to access findings of new research and how the results might apply to them. They will be directed to specific pages in the Web-based program and asked to select strategies from a list that they will practice during the upcoming week. Graphic displays of their progress will be provided along with SCT-based feedback. They will be directed to the website to record their behavioral goals for the upcoming week. Tips also will be provided for effective communication to enhance couple efficacy. All usage will be tracked to assess adherence.




Primary Outcome Measures :
  1. Body Weight [ Time Frame: baseline and 6 months ]
    Change in measured body weight


Secondary Outcome Measures :
  1. Waist Circumference [ Time Frame: baseline and 6 months ]
    measured with a non-stretch tape

  2. Physical Activity (self-reported) [ Time Frame: baseline, 3 months and 6 months ]
    Godin Leisure Time Physical Activity Questionnaire (4-item survey) - individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 - theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is "typical." The higher the number of minutes of totaled moderate + vigorous activity, the better.

  3. Physical Activity (objective) [ Time Frame: baseline, 6 months ]
    Accelerometry (7-day assessment)

  4. Diet Quality [ Time Frame: baseline and 6 months ]
    Two 24-hour dietary recalls

  5. Health Related Quality of Life (self-report) [ Time Frame: baseline, 3 months and 6 month ]
    Rand (35-item). Most items are on a 5-point Likert scale with some reverse scored and individual weighs are provided for items and subscales. The higher the score the better the health related quality of life with a theoretical minimum score of 0, ad a maximum score of 100.

  6. Comorbidity (self-report) [ Time Frame: baseline and 6 months ]
    Charlson Index (15-item survey). Respondents either affirm or deny the condition. The highest score is 15, the lowest is zero. It is better to have a lower score.

  7. Physical Performance (endurance) [ Time Frame: Baseline and 6 months ]
    2-minute step test

  8. Physical Performance (upper body strength) [ Time Frame: Baseline and 6 months ]
    hand grip strength

  9. Physical Performance (lower body strength) [ Time Frame: Baseline and 6 months ]
    30-second chair stand

  10. Physical Performance (agility) [ Time Frame: Baseline and 6 months ]
    8' foot up and go

  11. Blood pressure [ Time Frame: baseline and 6 months ]
    performed with a standard sphygomameter

  12. Self-efficacy for calorically restricted diet [ Time Frame: baseline, 3- and 6-months ]
    Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero)

  13. Self-efficacy for increased physical activity [ Time Frame: baseline, 3- and 6-months ]
    Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%).

  14. Social support for calorically restricted diet [ Time Frame: baseline, 3- and 6-months ]
    Clark et al. instruments (12 items). Respondents rate the level of support they obtain to follow a low calorie diet on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 48, whereas those with lesser support score lower (the minimum score is zero)

  15. Social support for calorically restricted diet [ Time Frame: baseline, 3- and 6-months ]
    Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)

  16. Social support for increased physical activity [ Time Frame: baseline, 3- and 6-months ]
    Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)

  17. Barriers for calorically restricted diet [ Time Frame: baseline, 3- and 6-months ]
    (21 items) Respondents either affirm or deny common barriers to eating a healthy, low calorie diet. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better.

  18. Barriers for increased physical activity [ Time Frame: baseline, 3- and 6-months ]
    (15 items in total)Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better.

  19. Serum insulin [ Time Frame: baseline and 6-months ]
    sera-based assays

  20. Serum Insulin-Like Growth Factor-1 (IGF-1) [ Time Frame: baseline and 6-months ]
    sera-based assay

  21. Serum TNFa [ Time Frame: baseline and 6-months ]
    sera-based assay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults age 18+ for whom at least one dyad member has been diagnosed and completed curative treatment for localized renal cancer, or loco-regional ovarian, colorectal, endometrial, or female breast cancer. (Loco-regional prostate cancer survivors are also eligible but could be on active surveillance).
  • Diagnosed as overweight or obese (BMI >25 kg/m2.
  • Low vegetable and fruit intake (<2.5 cups day).
  • Low physical activity (<150 minutes per week).
  • English-speaking and writing.
  • Completed at least 5th grade.
  • Uses the internet and owns a mobile phone.

Exclusion Criteria:

  • Diagnosed with uncontrolled chronic conditions (i.e., diabetes, blood pressure, CVD, etc)
  • Diagnosed with a health conditions that precludes adherence to an unsupervised weight loss intervention (e.g., pregnancy, end-stage renal disease, etc).
  • Instructed by a physician to limit physical activity AND have 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.
  • Diagnosed with other cancers (except non-malignant skin cancer), cancer recurrence or metastatic disease.
  • Resides in a skilled nursing or assisted living facility.
  • Resides more than 15 minute driving distance from dyad partner.

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): NCT04132219


Contacts
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Contact: Teri Hoenemeyer, PhD 2059740110 tgw318@uab.edu

Locations
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United States, Alabama
UAB School of Health Professions, Department of Nutrition Sciences Recruiting
Birmingham, Alabama, United States, 35294
Contact: Wendy Demark-Wahnefried, PhD    205-975-4022    demark@uab.edu   
Contact: Teri Hoenemeyer, PhD    2059740110    tgw318@uab.edu   
Principal Investigator: Wendy Demark-Wahnefried, PhD         
Sub-Investigator: Dorothy Pekmezi, PhD         
Sub-Investigator: Teri Hoenemeyer, PhD         
Sub-Investigator: Robert Oster, PhD         
Sub-Investigator: Laura Rogers, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Wendy Demark-Wahnefried, PhD, RD University of Alabama at Birmingham
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Responsible Party: Wendy Demark-Wahnefried, PhD, Professor and Webb Endowed Chair of Nutrition Sciences, University of Alabama at Birmingham (UAB) Associate Director of Cancer Prevention and Control, O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04132219    
Other Study ID Numbers: IRB-300003882
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan at the moment to share IDP.

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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
overweight
obesity
Additional relevant MeSH terms:
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Overweight
Body Weight