A Tailored, Web-based Program (COMPASS) to Improve Exercise and Dietary Changes in Stage I-III Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy
12 de junio de 2026 actualizado por: Kerri Winters, OHSU Knight Cancer Institute
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97239
- Reclutamiento
- OHSU Knight Cancer Institute
-
Contacto:
- Kerri Winters-Stone
- Número de teléfono: 503-494-0813
- Correo electrónico: wintersk@ohsu.edu
-
Investigador principal:
- Kerri Winters-Stone
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1 (COMPASS + brief coaching support)
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.
|
Web-based lifestyle program that provides tailored nutrition and physical activity recommendations and web-based support strategies including text messages, electronic trackers, and coaching
|
|
Experimental: Group 2 (COMPASS + enhanced coaching support)
Participants receive the same intervention as Group 1, but receive additional monthly coaching 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Accrual (Acceptability)
Periodo de tiempo: 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
|
Up to 12 months
|
|
Study retention (Acceptability)
Periodo de tiempo: 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.
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Up to 12 months
|
|
Listening session
Periodo de tiempo: 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.
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At completion of neoadjuvant chemotherapy (average of 6 months)
|
|
Exit survey
Periodo de tiempo: 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.
|
At completion of neoadjuvant chemotherapy (average of 6 months)
|
|
Study intervention adherence (Feasibility)
Periodo de tiempo: 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.
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Up to 12 months
|
|
Web portal visit frequency (Feasibility)
Periodo de tiempo: Up to 12 months
|
Will be measured by the number of times participants logged into the web portal during the intervention period.
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Up to 12 months
|
|
Web portal aggregate activity (Feasibility)
Periodo de tiempo: 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
|
Up to 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in self-report physical activity behavior
Periodo de tiempo: 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)
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At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
|
Change in dietary behavior
Periodo de tiempo: 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.
|
At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
|
Change in objectively measured physical activity (kcal/week)
Periodo de tiempo: 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)
|
At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
|
Change in objectively measured physical activity (daily step count)
Periodo de tiempo: 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.
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At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
|
Change in Self-efficacy for Exercise score
Periodo de tiempo: 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
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At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
|
Change in stages of change for exercise
Periodo de tiempo: 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.
|
At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
|
Healthy Eating and Weight Self-Efficacy
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
|
Change in cognitive function
Periodo de tiempo: 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.
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At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
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Change in neuropathy
Periodo de tiempo: 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
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At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
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Change in pain
Periodo de tiempo: 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.
|
At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
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Change in treatment dosing
Periodo de tiempo: 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.
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At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
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Incidence of adverse events
Periodo de tiempo: 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.
|
At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kerri Winters-Stone, OHSU Knight Cancer Institute
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de abril de 2026
Finalización primaria (Estimado)
31 de enero de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Neoplasias por sitio
- Neoplasias
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Neoplasias pancreáticas
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Atención al paciente
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Ejercicio
- Cuidados paliativos
Otros números de identificación del estudio
- STUDY00028600
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .