Clinical trial · Interventional
Daughters, dUdes, Mothers and othErs Fighting Cancer Together
Daughters, (dUdes), Mothers and othErs Fighting Cancer Together
NCT04132219CI-TRIAL-00062721DUETcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Overweight and Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eHealth Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate Intervention Group
- description
- 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.
- interventionNames
- Behavioral: eHealth Intervention
- type
- OTHER
- label
- Delayed Intervention Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDPekmezi 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
- DERIVEDKaur 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
- DERIVEDKaur 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