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Stage I Pancreatic Cancer AJCC v8NCT07651358

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

A study testing Physical Activity and Nutritional Recommendations and Support in people with Stage I Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, run by OHSU Knight Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Physical Activity and Nutritional Recommendations and Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
15 Apr 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Kerri Winters-Stone, 503-494-0813, wintersk@ohsu.edu

    Kerri Winters-Stone

    Recruiting

Other trials in United States

About this study

Official title: Community for Physical Activity and Supportive Nutrition Strategies (COMPASS)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Physical Activity and Nutritional Recommendations and Support
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity and Nutritional Recommendations and SupportBehavioural

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

Study groups in NCT07651358
Study groupRoleWhat they receive
Group 1 (COMPASS + brief coaching support)ExperimentalParticipants 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.
Receives: Behavioral: Physical Activity and Nutritional Recommendations and Support
Group 2 (COMPASS + enhanced coaching support)ExperimentalParticipants receive the same intervention as Group 1, but receive additional monthly coaching support
Receives: Behavioral: Physical Activity and Nutritional Recommendations and Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At completion of neoadjuvant chemotherapy (average of 6 months)

  5. 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.

    Measured: Up to 12 months

  6. Web portal visit frequency (Feasibility)

    Will be measured by the number of times participants logged into the web portal during the intervention period.

    Measured: Up to 12 months

  7. 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

    Measured: Up to 12 months

Secondary outcomes (14)

  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)

    Measured: 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.

    Measured: 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)

    Measured: 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.

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

  5. Change in Self-efficacy for Exercise score

    Will be measured using a 6-item measure of Self-efficacy for Exercise. Summed scores range from 6-30, and higher scores indicate higher self-efficacy

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

  6. Change in stages of change for exercise

    Will be assessed using the Physical Activity Stage Assessment (PASA) measure. Participants select one of five statements that best describes their current exercise behavior and readiness to engage in regular physical activity. Values range from 1 to 5, with higher values indicating greater engagement in and maintenance of regular exercise.

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

  7. Healthy Eating and Weight Self-Efficacy

    The Healthy Eating and Weight Self-Efficacy (HEWSE) questionnaire assesses participants' self-efficacy by asking them to rate their confidence in performing various tasks on a 1-5 Likert scale. A score of 1 indicates strong disagreement with their ability to accomplish the task, while a score of 5 indicates strong agreement. Higher scores indicate greater self-efficacy for healthy eating and weight management behaviors.

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

  8. Change in self-report physical functioning, quality of life, and cancer related symptoms

    Will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This outcome will assess overall quality of life and cancer-related symptoms. Scores range from 0 to 100. For the global health status and functional scales, higher scores indicate better quality of life and functioning. For symptom scales, higher scores indicate greater symptom burden and worse outcomes.

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

  9. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Symptom Measures

    Will be assessed using the Participant-Reported Outcomes Measurement Information System (PROMIS) measures for Sleep Disturbance, Depression, Anxiety, and Fatigue. Participants respond to 8-13 questions regarding their symptoms, with responses ranging from "Not at all" to "Very much." Scores are converted to standardized T-scores, with higher scores indicating greater symptom severity and worse outcomes.

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

  10. Change in cognitive function

    Will be assessed using the Participant-Reported Outcomes Measurement Information System Cognitive Function (PROMIS-CF) survey. This 32-item questionnaire assesses perceived difficulties with memory, cognitive processing, and the impact of cognitive problems on daily and social activities. Scores range from 0 to 100, with higher scores indicating better cognitive function and fewer perceived cognitive difficulties.

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

  11. Change in neuropathy

    Will be assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 4 (FACT-GOG-NXT-4). This 4-item survey captures symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. Higher scores indicate more symptoms

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

  12. Change in pain

    Will be assessed using the Participant-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity and Pain Interference measures. The Pain Intensity measure assesses the severity of pain, while the Pain Interference measure assesses the extent to which pain affects daily activities, social activities, and overall functioning. Scores range from 0 to 100, with higher scores indicating greater pain severity and greater interference of pain with daily functioning, representing worse outcomes.

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

  13. Change in treatment dosing

    These data will be available via the electronic health record and may be extracted to explore the impact of COMPASS on clinical outcomes including grade 3+ toxicities, dose delays and dose reductions.

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

  14. Incidence of adverse events

    Tolerance and safety will be assessed by adverse event reporting administered monthly by a survey administered by the web portal. Adverse events will be classified as related, possibly related, or not related to the intervention and graded as mild, moderate or severe.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2026
  2. Study start15 Apr 2026
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07651358
Sponsor's protocol ID
STUDY00028600
Status last verified
Jun 2026
First submitted
28 Apr 2026
Last updated
16 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity and Nutritional Recommendations and Support in people with Stage I Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accrual (Acceptability) (time frame: Up to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07651358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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