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Nutrition and Exercise Program for Cancer Survivors

N/A
Waitlist Available
Led By Emily B Hill, PhD, RDN
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For intervention participants: Men and women, Age 18-75 years, BMI 25-45 kg/m2, 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, 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, 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), Speak English, Have access to a computer or smart phone and Internet, Live or work within 30 miles of the AHWC (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects), Not be planning to travel for >2 consecutive weeks or relocate/move during the intervention, Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study, Capable and willing to give informed consent and understand exclusion criteria, 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, Not meeting dietary guidelines [i.e., Healthy Eating Index (HEI) score <80 as assessed via NCI DHQ III food frequency questionnaire] or physical activity guidelines
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial will test if it is possible and well-received to include a nutrition program for cancer survivors into an existing exercise program.

Who is the study for?
This trial is for individuals who are overweight or obese and have survived cancer. It's designed to see if a new nutrition program can work well alongside an existing exercise program made for cancer survivors.
What is being tested?
The study is testing the integration of 'BfedBwell', which includes group-based nutritional education, cooking demos, and individual counseling, into the 'BfitBwell' clinical exercise program for cancer survivors.
What are the potential side effects?
Since this trial focuses on nutrition and exercise interventions rather than medication, side effects may include muscle soreness from physical activity or changes in digestion due to diet adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the intervention acceptability by participants and program providers during qualitative interviews
Determine the intervention acceptability by participants using the Net Promoter Score (NPS)
Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM)
+6 more
Secondary study objectives
Assess preliminary efficacy for improvement in body composition
Assess preliminary efficacy for increased adherence to lifestyle recommendations
Assess preliminary efficacy for weight loss
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cancer SurvivorsExperimental Treatment4 Interventions
Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,588 Total Patients Enrolled
104 Trials studying Obesity
214,350 Patients Enrolled for Obesity
Emily B Hill, PhD, RDNPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
94 Total Patients Enrolled
~6 spots leftby Jan 2025
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