Daughters, dUdes, Mothers and othErs Fighting Cancer Together

NCT04132219 | Completed DMC

• 1 other identifier: IRB-300003882
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Overweight and Obesity

Keywords

cancer survivor; overweight; obesity

Outcome Measures

Primary Outcomes (2)

• Body Weight

  Change in measured body weight

  baseline

• Body Weight

  Change in measured body weight

  6 months

Secondary Outcomes (73)

• Waist Circumference

  baseline

• Waist Circumference

  6 months

• Physical Activity (self-reported)

  Baseline

• Physical Activity (self-reported)

  3 months

• Physical Activity (self-reported)

  6 months

Other Outcomes (6)

• Relationship to chosen partner

  Baseline

• Socio-Demographic (George, et al, 1984)

  Baseline

• Socio-Demographic (George, et al, 1984)

  3 months

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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

Delayed Intervention Group

OTHER

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

Interventions

eHealth Intervention BEHAVIORAL

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; Immediate Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB School of Health Professions, Department of Nutrition Sciences

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

• Pekmezi DW, Crane TE, Oster RA, Rogers LQ, Hoenemeyer T, Farrell D, Cole WW, Wolin K, Badr H, Demark-Wahnefried W. Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Nutrients. 2021 Sep 29;13(10):3472. doi: 10.3390/nu13103472.

  PMID: 34684474 BACKGROUND

• Kaur H, Pekmezi D, E Crane T, Farrell D, Q Rogers L, Demark-Wahnefried W. Website Use and Associations With Behavior Change and Weight Loss in Cancer Survivors and Their Partners: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2026 Jan 30;28:e86908. doi: 10.2196/86908.

  PMID: 41617212 DERIVED

• Kaur H, Pavela G, Pekmezi DW, Rogers LQ, Cole WW, Parrish KB, Sayer RD, Wyatt HR, Crane TE, Badr H, Demark-Wahnefried W. Living together-does it help or hinder the pursuit of a healthful diet, physical activity, and weight loss among cancer survivors and their chosen partners? Support Care Cancer. 2024 Oct 3;32(10):700. doi: 10.1007/s00520-024-08907-3.

  PMID: 39361227 DERIVED

MeSH Terms

Conditions

Neoplasms; Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy Demark-Wahnefried, PhD, RD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors of anthropometric, physical function, patient reported outcomes and biospecimens are blinded to arm status
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 18, 2019
• Study Start: October 15, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)