Clinical trial · Interventional
Healthy Living After Cancer: Weight Management Pilot Study
- 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)
Studies have shown that patients who weigh more at the time of cancer diagnosis may be at increased risk of complications from surgery, fatigue, poor body image and other problems. Some research suggests that losing weight after cancer diagnosis can lead to improvements in these problems, as well as having other potential benefits for cancer survivors. Programs that reduce calories and increase exercise have been shown to help cancer survivors lose weight, but more research is needed to develop and test weight loss programs in cancer survivors. This study is designed to look at the ability of a 15-week diet and exercise program to help cancer survivors lose weight. The investigator will look at changes in weight, body composition, quality of life, fatigue, body image as well as diet and exercise patterns, to see if this program can help men and women feel better and live healthier lives after cancer diagnosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Weight Loss Program After Cancer Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Delayed Weight Loss Program Group | Behavioral | — | UNRESOLVED |
| Immediate Weight Loss Program Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Immediate Weight Loss Program Group
- description
- Immediate Weight Loss Program Group * The weight loss Program Group will include weekly in-person sessions comprised of dietary counseling and increased physical activity. Patients will also be provided with exercise and dietary goals each week to implement at home. * Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks.
- interventionNames
- Behavioral: Immediate Weight Loss Program Group
- type
- ACTIVE_COMPARATOR
- label
- Delayed Weight Loss Program Group
- description
- The Delayed Weight Loss Program Group will take part in the weight loss intervention after the 16-week control period. Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks
- interventionNames
- Behavioral: Delayed Weight Loss Program Group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent prior to any study-related procedures * History of any malignancy * Completed with all adjuvant surgery, chemotherapy and/or radiation at least one month prior to study enrollment (patients receiving ongoing hormonal or biologic therapy are eligible to participate) * BMI \>25kg/m2 * ECOG performance status of 0 or 1 * At least 18 years old * Physically able to exercise and physician consent to start a weight loss program * Willingness to be randomized * English speaking and able to read English Exclusion Criteria: * Self-reported inability to walk 2 blocks (at any pace) * Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet. * Bariatric surgery within the last year * Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility. * Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
References
Publications (1)
- DERIVEDBrown JC, Giobbie-Hurder A, Yung RL, Mayer EL, Tolaney SM, Partridge AH, Ligibel JA. The effects of a clinic-based weight loss program on health-related quality of life and weight maintenance in cancer survivors: A randomized controlled trial. Psychooncology. 2022 Feb;31(2):326-333. doi: 10.1002/pon.5817. Epub 2021 Sep 12. PMID 34510643