BfedBwell INSPIRE Pilot

NCT07446595 | Recruiting DMC

• 3 other identifiers: 26-0077.ccIRC_FULL_2025_004NCI-2026-02279
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, exercise, sleep health, and stress management. The intervention integrates the BfedBwell survivorship nutrition program with the BfitBwell clinical exercise oncology program. The augmented BfedBwell program includes: (1) a core education curriculum, (2) 1:1 counseling with a registered dietitian, (3) behavioral skills development, (4) group support, and (5) commercially available wearable technology and smart scales for self-monitoring of physical activity, sleep, and body weight.

Conditions

Cancer Survivorship; Overweight , Obesity

Keywords

Adult Cancer Survivor; Lifestyle Behavior; Diet, food, and nutrition; Exercise; Sleep; Stress

Outcome Measures

Primary Outcomes (6)

• Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention

  Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll

  24 weeks

• Determine the research protocol adherence feasibility of the augmented BfedBwell nutrition intervention

  Adherence will be assessed as \[# sessions attended/# sessions provided\]

  24 weeks

• Determine the research protocol outcome assessment feasibility of the augmented BfedBwell nutrition intervention

  Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\]

  24 weeks

• Determine the research protocol retention feasibility of the augmented BfedBwell nutrition intervention

  Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants enrolled\]

  24 weeks

• Determine the intervention acceptability by participants during focus groups

  Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention.

  24 weeks

• Determine the intervention acceptability by participants using the Net Promoter Score (NPS)

  Participants will be asked to complete weekly ratings using the Net Promoter Score (NPS). Respondents are grouped as follows: 1) promoters (score 9-10) are loyal enthusiasts who will keep referring others and fueling growth, 2) passives (score 7-8) are satisfied but unenthusiastic customers who are vulnerable to competitive offerings, and 3) detractors (score 0-6) are unhappy customers who can impede growth with negative word-of-mouth. The final NPS score is calculated as % promoters - % detractors. NPS scores range from -100 to +100, with scores \>/=0 indicating good acceptability.

  12 and 24 weeks

Secondary Outcomes (2)

• Measure changes in self-reported sleep quality

  Baseline and 12 and 24 weeks

• Measure changes in perceived stress

  Baseline and 12 and 24 weeks

Study Arms (1)

BfedBwell INSPIRE Intervention

EXPERIMENTAL

Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.

Behavioral: BfedBwell - Core Curriculum; Behavioral: BfedBwell - 1:1 Counseling; Behavioral: BfedBwell - Behavioral Skills; Behavioral: BfedBwell - Group Support; Behavioral: BfedBwell - Technology; Behavioral: BfitBwell - Clinical Exercise Program

Interventions

BfedBwell - Behavioral Skills BEHAVIORAL

Group-based behavioral skills development sessions and cooking demonstrations to focus on behavior change techniques (e.g., self-monitoring, goal setting) and nutrition skills (e.g., recipe development, label reading)

BfedBwell INSPIRE Intervention

BfedBwell - Group Support BEHAVIORAL

Structured group support sessions to share experiences

BfedBwell INSPIRE Intervention

BfedBwell - Technology BEHAVIORAL

Commercially available devices (fitness trackers, smart scales) for self-monitoring of physical activity, sleep, and body weight

BfedBwell INSPIRE Intervention

BfitBwell - Clinical Exercise Program BEHAVIORAL

Supervised exercise program developed by a cancer exercise specialist and based upon the NCCN guidelines for physical activity during cancer survivorship and other recommendations

BfedBwell INSPIRE Intervention

BfedBwell - Core Curriculum BEHAVIORAL

Group-based education sessions based upon guidelines for nutrition and lifestyle behaviors for cancer survivorship

BfedBwell INSPIRE Intervention

BfedBwell - 1:1 Counseling BEHAVIORAL

Individual 1:1 counseling sessions with a registered dietitian to review progress and address barriers

BfedBwell INSPIRE Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• BMI 25-45 kg/m2
• History of cancer within the past 10 years with a diagnosis of an adulthood cancer of any type
• In maintenance or surveillance status, defined as completion of active cancer therapy (e.g., surgery, radiation, chemotherapy, immunotherapy) with curative intent at least 3 months and no more than 10 years prior to enrollment or active surveillance with no treatment; ongoing targeted or hormone therapies ≥3 months prior to intervention start date and/or ongoing maintenance therapy ≥1 year is permitted (exceptions to this timeframe for completion of other therapies can be made on a case-by-case basis by the PI if patients are tolerating therapy without adverse effects and will have completed active treatment or been in stable maintenance treatment prior to the intervention start date)
• 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 (NCCN) guidelines (note: any positive responses will trigger a required physician clearance form)
• Speak English
• Have access to a computer or smart phone and Internet to join Zoom meetings, complete questionnaires, and access/download the True Coach virtual exercise coaching sessions
• 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 for major elective surgery, to travel for \>2 consecutive weeks, or relocate/move during the intervention (\~6 months)
• No nicotine or tobacco use within previous 6 months
• Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study

You may not qualify if:

• Willing to attend weekly small group education sessions, monthly behavioral skills development sessions, weekly group support sessions, and monthly 1:1 counseling sessions with a registered dietitian (RD)
• Willing to attend up to two BfitBwell exercise sessions (one in person supervised, one virtual unsupervised) per week for first 12 weeks then once monthly supervised and once weekly unsupervised virtual sessions for second 12 weeks
• 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 \[i.e., \<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\] (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)
• Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher
• Actively undergoing chemotherapy, radiation, immunotherapy with curative intent or within 3 months of completion of surgery, chemotherapy, or radiation treatment or recent initiation of targeted/hormonal therapy (\<3 months) or maintenance therapy (\<1 year) unless well-tolerated and deemed acceptable by PI on a case-by-case basis
• Greater than 10 years post-active or maintenance therapy
• Plans to relocate within the next 6 months
• Plans for extended travel (\>2 weeks) within the next 6 months
• 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
• Any major surgery within the past 3 months or planned elective surgery during the intervention period, including mastectomy
• Have completed treatment that significantly impacts digestion, metabolism, and/or food intake (e.g., surgical loss of esophagus, stomach, colon)
• Recent (past 6 months) acute coronary event, unstable angina, coronary revascularization, stroke, or pulmonary embolism
• Symptoms suggestive of cardiovascular disease (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, syncope)
• 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)
• Diabetes (history of type 1 or type 2 diabetes, hemoglobin A1c ≥6.5%, 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 or DPP-V inhibitor monotherapy with hemoglobin A1c \<8%

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Institute for Cancer Research: collaborator

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Emily Hill, PhD, RDN

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Mamele, MS, RD, CSCS

CONTACT

303-724-2488; bfedbwell@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)