An Exercise and Nutrition Monitoring Intervention (Pt Pal) for the Improvement of Strength in Pat… (NCT05056805) | Clinical Trial Compass
WithdrawnNot Applicable
An Exercise and Nutrition Monitoring Intervention (Pt Pal) for the Improvement of Strength in Patients With Pancreatic or Stomach Cancer Receiving Chemoradiation Therapy Before Surgery, SurgeryStrong Study
Stopped: No participants enrolled.
0Started 2021-03-04
Plain-language summary
This clinical trial studies the effectiveness of a home-based exercise and nutrition monitoring program called Pt Pal in improving strength in patients with pancreatic or stomach cancer receiving chemoradiation therapy before surgery. Pt Pal is a mobile health technology used to facilitate communication between the care team and the patient/caregiver, by allowing the care team to send from their web-portal, exercise routines, activities of daily living, diet recommendations, surveys and educational material to the patient/caregiver's mobile device. The Pt Pal application (app) then captures the patient/caregiver activity adherence data and reports those results back to the care team. The Pt Pal program may help improve overall strength in patients undergoing surgery for pancreatic and stomach cancer relative to standard care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pancreatic or gastric adenocarcinoma, biopsy-proven
* Have completed or are within 2 weeks of completion of preoperative chemoradiotherapy either on- or off-protocol
* Anticipated to undergo potentially curative resection in 4-6 weeks from enrollment
* Able to understand the description of the study and willing to participate
* Able to understand the exercise program
* Able to independently maintain daily exercise logs via Pt Pal -iOS, Android or desktop web browser on their own personal device
* Telephone or email access and agreement to engage with the research personnel via phone or email
* Meet all screening requirements, including physician clearance
* \>= age 18
Exclusion Criteria:
* Non-English speaking
* Has participated in moderate to high intensity strengthening exercises at least two times per week within the past four weeks prior to enrollment
* Unable to complete the baseline assessment questionnaires or functional assessments
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
* Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
* Numeric pain rating scale of \>= 7 out of 10
* Myopathic or rheumatologic disease that impacts physical function
* Recurrent cancer following prior resection
* \< age 18
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in dynamic lower muscle strength
Timeframe: through study completion, an average of a year