Cancer Survivorship, Overweight , Obesity
Conditions
Keywords
Adult Cancer Survivor, Lifestyle Behavior, Diet, food, and nutrition, Exercise, Sleep, Stress
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.
Detailed description
Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 6-month single-arm study of the augmented BfedBwell + BfitBwell interventions. Feasibility and acceptability of integrating commercially-available wearable technology and smart scales will be evaluated. The study will also explore preliminary changes in sleep quality, perceived stress, and physiological indicators of stress and immune function.
Interventions
BEHAVIORALBfedBwell - Core Curriculum
Group-based education sessions based upon guidelines for nutrition and lifestyle behaviors for cancer survivorship
BEHAVIORALBfedBwell - 1:1 Counseling
Individual 1:1 counseling sessions with a registered dietitian to review progress and address barriers
BEHAVIORALBfedBwell - Behavioral Skills
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)
BEHAVIORALBfedBwell - Group Support
Structured group support sessions to share experiences
BEHAVIORALBfedBwell - Technology
Commercially available devices (fitness trackers, smart scales) for self-monitoring of physical activity, sleep, and body weight
BEHAVIORALBfitBwell - Clinical Exercise Program
Supervised exercise program developed by a cancer exercise specialist and based upon the NCCN guidelines for physical activity during cancer survivorship and other recommendations
Sponsors
University of Colorado, Denver
American Institute for Cancer Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Capable and willing to give informed consent and understand
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention | 24 weeks | Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll |
| Determine the research protocol adherence feasibility of the augmented BfedBwell nutrition intervention | 24 weeks | Adherence will be assessed as \[# sessions attended/# sessions provided\] |
| Determine the research protocol outcome assessment feasibility of the augmented BfedBwell nutrition intervention | 24 weeks | Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\] |
| Determine the research protocol retention feasibility of the augmented BfedBwell nutrition intervention | 24 weeks | Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants enrolled\] |
| Determine the intervention acceptability by participants during focus groups | 24 weeks | Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention. |
| Determine the intervention acceptability by participants using the Net Promoter Score (NPS) | 12 and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure changes in self-reported sleep quality | Baseline and 12 and 24 weeks | 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. |
| Measure changes in perceived stress | Baseline and 12 and 24 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily Hill, PhD, RDN
University of Colorado, Denver
Outcome results
None listed