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Can a diet program help cancer survivors get healthier? new study says maybe.

NCT ID NCT06191666

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding a nutrition program to an existing exercise program is practical and well-liked by cancer survivors who are overweight or obese. Twenty adults who finished cancer treatment joined a 12-week program combining diet advice with exercise. The goal was to see if people would stick with it and find it helpful, not to measure weight loss or cure cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Feb 2024

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For program delivery staff: 1. Men and women 2. Age ≥ 18 years 3. Speak English 4. Self-reported previous experience in the delivery of nutrition, exercise, or behavioral weight management programs For intervention participants: 1. Men and women 2. Age 18-75 years 3. Body Mass Index 25-45 kg/m2 4. Completion of active cancer therapy with curative intent at least three months and no more than five years prior to enrollment; ongoing hormone therapy is permitted 5. Have a primary care provider (or are willing to establish care with a primary care provider prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions and who will provide clearance to participate in a nutrition and exercise program 6. Ability and willingness to participate in a supervised exercise program; with ability assessed by the Physical Activity Readiness Questionnaire (PAR-Q+) and questions based upon National Comprehensive Cancer Network guidelines (note: any positive responses will trigger a required physician clearance form) 7. Speak English 8. Have access to a computer or smart phone and Internet 9. Live or work within 30 miles of the Anschutz Health and Wellness Center (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects) 10. Not be planning to travel for \>2 consecutive weeks or relocate/move during the intervention 11. Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study 12. Capable and willing to give informed consent and understand exclusion criteria 13. Willing to attend weekly small group sessions (behavioral skills development and/or group support) and/or 1:1 counseling held by a registered dietitian (RD) and attend up to two BfitBwell exercise sessions per week 14. Not meeting dietary guidelines \[i.e., Healthy Eating Index (HEI) score \<80 as assessed via National Cancer Institute Diet History Questionnaire III (NCI DHQ III) food frequency questionnaire\] or physical activity guidelines \[i.e., \<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\] Exclusion Criteria: For program delivery staff: None For intervention participants: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher 2. Actively undergoing cancer therapy or within 3 months of completion of surgery, chemotherapy, or radiation treatment 3. Greater than 5 years post-active therapy 4. Plans to relocate within the next 6 months 5. Plans for extended travel (\>2 weeks) within the next 6 months 6. For females: 1. Currently pregnant or lactating 2. Pregnant within the past 6 months 3. Planning to become pregnant in the next 18 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception 7. Any major surgery within the past 3 months, including mastectomy 8. Have completed treatment that significantly impacts digestion, metabolism, and/or food intake (e.g., surgical loss of esophagus, stomach, colon) 9. Recent (past 6 months) acute coronary event, unstable angina, coronary revascularization, stroke, or pulmonary embolism 10. Symptoms suggestive of cardiovascular disease (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, syncope) 11. Uncontrolled hypertension, defined as diastolic blood pressure \>100 mmHg, systolic blood pressure \>160 mmHg, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position (if screening is needed due to lack of updated medical record within previous 12 months) 12. Diabetes (history of type 1 or type 2 diabetes, hemoglobin A1c \>7.5%, or fasting glucose ≥126 mg/dL as measured during the screening visit if screening is needed due to lack of updated medical record within previous 12 months) unless well controlled on metformin alone 13. History of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen is acceptable 14. Triglycerides \>500 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months) 15. LDL cholesterol \>200 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months) 16. Presence or history of other metabolic or chronic health problems which would impact ability to safely participate in a weight loss intervention involving diet and exercise: significant cardiac arrhythmias or cardiac valvular disease, significant gastrointestinal, pulmonary, renal, musculoskeletal, neurologic, hematologic, or psychiatric disease 17. Have started lipid-lowering, hypertension, or oral hypoglycemic medication in previous 3 months 18. Sustained use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., obesity pharmacotherapeutics agents, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) with the exception of anti-endocrine or Her2 directed treatment for breast cancer and standard of care anti-emetic or anti-diarrheal agents. 19. Sustained use of systemic glucocorticoids (current or in the past 6 months) unless physiologic replacement therapy for adrenal insufficiency 20. Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed \>1 year before screening, (2) lap banding if the band has been removed \>1 year before screening, (3) intragastric balloon if the balloon has been removed \>1 year before screening, (4) duodenal-jejunal bypass sleeve if the sleeve has been removed \>1 year before screening, or (5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \>1 year before screening 21. Participation within previous 6 months, current participation in, or planning to participate in any formal nutrition, weight loss, or physical activity programs or clinical trials over the next 6 months 22. Previous participation the BfitBwell exercise oncology program 23. Current alcohol or substance abuse as assessed by the Cut down, Annoyed, Guilty, and Eye-Opener (CAGE) questionnaire (note: study PI will follow up if screener raises any concerns of substance abuse to determine final eligibility) 24. History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score \>20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the study MD to determine if it is appropriate for the subject to participate in the study 25. Current severe depression or history of severe depression within the previous year, based on Center for Epidemiologic Studies Depression Scale (CES-D) 26. History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions 27. Have medical or physical limitations or contraindications to engaging in physical activity (e.g., severe orthopedic conditions, paralysis) or are considered high-risk based on American College of Sports Medicine (ACSM) guidelines 28. Are cognitively unable to consent

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.