Health TrialsbyHealthPanel

BfedBwell INSPIRE Pilot

ConditionsCancer SurvivorshipOverweight , Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • BfedBwell - Core Curriculum

    Behavioral

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

  • BfedBwell - 1:1 Counseling

    Behavioral

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

  • 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 - Group Support

    Behavioral

    Structured group support sessions to share experiences

  • BfedBwell - Technology

    Behavioral

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

  • 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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: BfedBwell INSPIRE InterventionExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
24 weeks
2

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

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

Time frame
24 weeks
3

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

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

Time frame
24 weeks
4

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

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

Time frame
24 weeks

Secondary outcomes

1

Measure changes in self-reported sleep quality

Participants will complete the Pittsburgh Sleep Quality Index (PSQI) to evaluate perceived sleep quality. The PSQI contains 19 self-rated questions assessing several factors relating to sleep quality, and the resulting global score ranges from 0-21 points. Higher scores indicate worse sleep quality.

Time frame
Baseline and 12 and 24 weeks
2

Measure changes in perceived stress

Participants will complete the Perceived Stress Scale (PSS) to assess self-reported psychological stress. The PSS contains 10 questions assessing perceived stress, and the resulting total score ranges from 0-40 points. Higher scores indicate greater perceived stress.

Time frame
Baseline and 12 and 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

American Institute for Cancer Research

Collaborator

Source ClinicalTrials.gov
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