A Brief Psychological Intervention to Improve Emotional Well-Being During Neoadjuvant Therapy for Pancreatic Cancer
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About
This clinical trial tests how well a psychosocial oncology intervention with standard prehabilitation during neoadjuvant therapy works for patients with pancreatic cancer that has not spread to other parts of the body (localized). Chemotherapy and/or radiation therapy prior to surgery, is known as neoadjuvant therapy (NT). The advantages of therapy before surgery include: reducing the size of the cancer mass and/or reducing the spread of cancer, to improve the chance of getting all the cancer during surgery. Other research has shown that doing treatments in this order does lead to improved survival and a lower rate of the cancer returning. Even though there are positives, patients are dealing with emotional and physical symptoms of waiting until the therapies are done to get to surgery. To prepare patients for recovering after chemotherapy and/or radiation therapy to be ready for surgery, care teams have started prehabilitation programs. Prehabilitation includes exercise therapy and nutrition (healthy diet) support before going to surgery. This program has helped boost patients' strength to complete therapies, reduce the number of days in the hospital after surgery and support healing. While meeting with psychologists is available, researchers would like to see if combining it earlier during treatments may provide better support. An oncology (cancer) psychologist while undergoing cancer treatments before surgery may be feasible and helpful to patients with localized pancreatic cancer.
Full description
PRIMARY OBJECTIVES:
I. To test the feasibility and acceptability of incorporating a psychosocial oncology intervention for patients with pancreatic cancer undergoing neoadjuvant therapy prior to surgical resection.
II. To measure the preliminary efficacy of prehabilitation that includes psychosocial oncology on quality of life and stress/anxiety.
OUTLINE:
Patients participate in a psychosocial oncology intervention consisting of meeting with a psychologist via telehealth sessions over 40 minutes once a week for 4 weeks on study. Patients also attend standard physical therapy and nutritional therapy appointments.
Enrollment
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Volunteers
Inclusion criteria
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Adults ≥ 18 years of age
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Patient:
- Newly diagnosed patients with localized pancreatic ductal adenocarcinoma (PDAC) presenting to Ohio State University Wexner Medical Center-Comprehensive Cancer Center (OSUMC-CCC)
- Plans to initiate neoadjuvant therapy prior to surgical resection
- Neoadjuvant therapy (NT) and/or surgery may occur at another facility
Exclusion criteria
- Prisoners
- Persons unable to provide consent
- Patients unlikely to undergo surgical resection following NT based on anatomical or performance status considerations
- Confirmed or presumed metastatic disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
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Central trial contact
The Ohio State University Comprehensive Cancer Center
Data sourced from clinicaltrials.gov
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