Stage III Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, Stage I Pancreatic Cancer AJCC v8
Conditions
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.
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
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
Sponsors
OHSU Knight Cancer Institute
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual (Acceptability) | Up to 12 months | 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 |
| Study retention (Acceptability) | Up to 12 months | 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. |
| Listening session | At completion of neoadjuvant chemotherapy (average of 6 months) | 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. |
| Exit survey | At completion of neoadjuvant chemotherapy (average of 6 months) | 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. |
| Study intervention adherence (Feasibility) | Up to 12 months | 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. |
| Web portal visit frequency (Feasibility) | Up to 12 months | Will be measured by the number of times participants logged into the web portal during the intervention period. |
| Web portal aggregate activity (Feasibility) | Up to 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-report physical activity behavior | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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) |
| Change in dietary behavior | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Change in objectively measured physical activity (kcal/week) | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | Physical activity will be measured using a Fitbit device for energy expenditure (kcal/week) |
| Change in objectively measured physical activity (daily step count) | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Change in Self-efficacy for Exercise score | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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 |
| Change in stages of change for exercise | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Healthy Eating and Weight Self-Efficacy | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Change in self-report physical functioning, quality of life, and cancer related symptoms | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Symptom Measures | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Change in cognitive function | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Change in neuropathy | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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 |
| Change in pain | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Change in treatment dosing | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
| Incidence of adverse events | At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKerri Winters-Stone
OHSU Knight Cancer Institute
Outcome results
None listed