Community for Physical Activity and Supportive Nutrition Strategies (COMPASS)
Summary
This clinical trial studies whether a tailored, web-based program (web portal), Community for Physical Activity and Supportive Nutrition Strategies (COMPASS), can be used to improve exercise and dietary changes in patients with stage I-III pancreatic cancer who are receiving chemotherapy before surgery (neoadjuvant). Pancreatic cancer is a rare and understudied cancer, particularly in the area of promoting a healthy lifestyle to preserve physical and mental well-being during a long and difficult treatment regimen. Since pancreatic cancer is rare, programs have limited resources available to reach the patients who could benefit from programs aimed at promoting exercise and a healthy diet. The COMPASS web-portal is easily accessed by the patient via a computer, tablet, or phone. It is tailored to the unique needs of pancreatic cancer patients and provides exercise and diet recommendations along with behavioral support as they undergo the long process of cancer therapy. This may be a more effective way to reach and engage with the patient, which may improve exercise and dietary changes in stage I-III pancreatic cancer patients receiving neoadjuvant chemotherapy.
Detailed description
PRIMARY OBJECTIVE: I. Acceptability of the COMPASS web portal will be assessed through accrual, study retention, end-of-study focus groups, and exit surveys, while feasibility will be measured by adherence to prescribed recommendations, frequency of portal visits, and aggregate web portal usage data. SECONDARY OBJECTIVE: I. To evaluate the preliminary effectiveness of COMPASS on exercise and diet habits, self-efficacy for behavior change, stages of change for exercise, changes in physical and mental well-being, and treatment tolerance (treatment-related symptoms, side effects, # of dose reductions) at baseline, 3 months and post chemotherapy. TERTIARY OBJECTIVE: I. To compare outcomes between participants assigned to a single health coaching session or monthly coaching sessions. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP 1: Patients receive access to COMPASS portal, a tailored exercise intervention which may consist of strength, aerobic, balance, and flexibility exercises, and tailored diet recommendations for the duration of neoadjuvant chemotherapy. Patients also attend two review sessions to discuss the tailored exercise intervention and dietary recommendations and may optionally receive motivational and support text messages three times a week (TIW) on study. GROUP 2: Patients receive access to COMPASS portal, a tailored exercise intervention which may consist of strength, aerobic, balance, and flexibility exercises, and tailored diet recommendations for the duration of neoadjuvant chemotherapy. Patients also attend two review sessions to discuss the tailored exercise intervention and dietary recommendations and receive a coaching call once a month on study. Additionally, patients may optionally receive motivational and support text messages TIW on study.
Arms & interventions
- BehavioralPhysical Activity and Nutritional Recommendations and Support
Web-based lifestyle program that provides tailored nutrition and physical activity recommendations and web-based support strategies including text messages, electronic trackers, and coaching
Outcome measures
Primary
Accrual (Acceptability)
Accrual will be measured by the number of eligible patients who enroll in the study divided by the total number approached for recruitment. Successful accrual will be defined as recruiting 30 pancreatic cancer patients
Time frame: Up to 12 months
Study retention (Acceptability)
Measured by the number of participants who enroll and complete the study intervention during their neoadjuvant chemotherapy treatment. Successful retention will be if 80% (24) participants complete the study's intervention while in neoadjuvant chemotherapy.
Time frame: Up to 12 months
Listening session
A minimum of 2 and maximum of 4 virtual listening sessions, at least one of men and one of women will be conducted. Each group will consist of 8-10 individuals and will explore questions of ease of use, whether they felt the portal was engaging and effectively encouraged positive behaviors. Information will also be sought about how the portal may be improved.
Time frame: At completion of neoadjuvant chemotherapy (average of 6 months)
Exit survey
This survey will assess which parts of the web portal and intervention participants felt were most useful. The survey includes questions about each component of the web portal and intervention, with responses ranging from "Strongly Disagree" to "Strongly Agree," as well as open-ended questions that allow participants to provide additional thoughts or comments about the web portal.
Time frame: At completion of neoadjuvant chemotherapy (average of 6 months)
Study intervention adherence (Feasibility)
Adherence will be defined as the proportion of participants who achieve at least one prescribed weekly exercise goal or nutrition recommendation during ≥80% of the weeks of their neoadjuvant chemotherapy period. Values range from 0% to 100%, with higher percentages indicating greater adherence to the study intervention.
Time frame: Up to 12 months
Web portal visit frequency (Feasibility)
Will be measured by the number of times participants logged into the web portal during the intervention period.
Time frame: Up to 12 months
Web portal aggregate activity (Feasibility)
The number of clicks on specific web portal components, most frequently visited web pages, average time spent on the web portal and on different sections, time spent logging information or syncing Fitbit data
Time frame: Up to 12 months
Secondary
Change in self-report physical activity behavior
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in dietary behavior
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in objectively measured physical activity (kcal/week)
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in objectively measured physical activity (daily step count)
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in Self-efficacy for Exercise score
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in stages of change for exercise
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Healthy Eating and Weight Self-Efficacy
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in self-report physical functioning, quality of life, and cancer related symptoms
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Symptom Measures
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in cognitive function
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in neuropathy
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in pain
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Change in treatment dosing
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Incidence of adverse events
Time frame: At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
Eligibility criteria
Study locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239