A Tailored, Web-based Program (COMPASS) to Improve Exercise and Dietary Changes in Stage I-III Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy

Official title

Community for Physical Activity and Supportive Nutrition Strategies (COMPASS)

Overview

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.

Interventions

• Behavioral Physical 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

Primary outcome measures

• Accrual (Acceptability) [Time frame: Up to 12 months]
• Study retention (Acceptability) [Time frame: Up to 12 months]
• Listening session [Time frame: At completion of neoadjuvant chemotherapy (average of 6 months)]
• Exit survey [Time frame: At completion of neoadjuvant chemotherapy (average of 6 months)]
• Study intervention adherence (Feasibility) [Time frame: Up to 12 months]
• Web portal visit frequency (Feasibility) [Time frame: Up to 12 months]
• Web portal aggregate activity (Feasibility) [Time frame: Up to 12 months]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• Age 18 years or older on date of enrollment

• Confirmed by review of the date of birth as documented in the electronic medical record (EMR) and subsequently recorded in a case report form (CRF)
• Diagnosed with stage I-III pancreatic cancer

• Confirmed by EMR review. In cases where the EMR is unclear, their physician will be contacted and asked to confirm
• Scheduled to receive neoadjuvant chemotherapy at Oregon Health \& Science University (OHSU)

• Confirmed by EMR review. In cases where the EMR is unclear, their physician will be contacted and asked to confirm
• Willing to adhere to the study protocol

• Confirmed verbally with the participant and response documented in the Participant Tracking database

Exclusion criteria

• Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent

• In the event of a suspected undeclared cognitive impairment, it will be confirmed by physician clearance or professional opinion of the Principal Investigators, Dr. Kerri Winters-Stone and/or Dr. Jackilen Shannon
• A medical condition, movement or neurological disorder, or medication use that contraindicates participation in light intensity exercise

• Confirmed by a combination of reviewing the EMR, and self-report during the initial screening call. If in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone or Dr. Jackilen Shannon, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible
• Not fluent in English and therefore incapable of answer survey questions, reading the intervention web portal, and providing informed consent in English

• Confirmed verbally with the participant and response documented in the Participant Tracking database

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• OHSU Knight Cancer Institute — Portland

Identifiers

NCT: NCT07651358 · STUDY00028600

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗