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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group 1 (COMPASS + brief coaching support)Experimental treatment 1 intervention
Group B: Group 2 (COMPASS + enhanced coaching support)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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)
4

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)

Secondary outcomes

1

Change in self-report physical activity behavior

Will be assessed using the Community Health Activities Model Program physical activity survey as total energy expended in moderate to vigorous physical activity per week (kcal/week)

Time frame
At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
2

Change in dietary behavior

Will be assessed using the Diet Questionnaire for Oncology Participants. This survey assesses the frequency of consumption of specific foods or food groups (e.g., bread, cereal, milk, fruit juice) and how much of each food they typically eat per week.

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

Change in objectively measured physical activity (kcal/week)

Physical activity will be measured using a Fitbit device for energy expenditure (kcal/week)

Time frame
At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
4

Change in objectively measured physical activity (daily step count)

Physical activity will be measured using a Fitbit activity monitor and reported as average daily step count. Daily step count represents the total number of steps accumulated during a day. Possible values range from 0 steps to no defined upper limit. Higher values (average daily steps) indicate greater physical activity.

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

Other outcomes

Sponsors and contacts

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

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator