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

NCT07651358 | Recruiting

• 1 other identifier: STUDY00028600
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stage I Pancreatic Cancer AJCC v8; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8

Outcome Measures

Primary Outcomes (7)

• 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

  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.

  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.

  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.

  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.

  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.

  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

  Up to 12 months

Secondary Outcomes (14)

• Change in self-report physical activity behavior

  At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months

• Change in dietary behavior

  At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months

• Change in objectively measured physical activity (kcal/week)

  At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months

• Change in objectively measured physical activity (daily step count)

  At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months

• Change in Self-efficacy for Exercise score

  At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months

Study Arms (2)

Group 1 (COMPASS + brief coaching support)

EXPERIMENTAL

Participants 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. Participants also receive an initial coaching call to discuss the tailored exercise intervention and dietary recommendations and may optionally receive motivational and support text messages TIW on study.

Behavioral: Physical Activity and Nutritional Recommendations and Support

Group 2 (COMPASS + enhanced coaching support)

EXPERIMENTAL

Participants receive the same intervention as Group 1, but receive additional monthly coaching support

Behavioral: Physical Activity and Nutritional Recommendations and Support

Interventions

Physical Activity and Nutritional Recommendations and Support BEHAVIORAL

Web-based lifestyle program that provides tailored nutrition and physical activity recommendations and web-based support strategies including text messages, electronic trackers, and coaching

Group 1 (COMPASS + brief coaching support); Group 2 (COMPASS + enhanced coaching support)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Exercise; Palliative Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kerri Winters-Stone

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: June 16, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

US (1)