NCT07124611

A Brief Psychological Intervention to Improve Emotional Well-Being During Neoadjuvant Therapy for Pancreatic Cancer

Testing the Feasibility of Incorporating Psychosocial Oncology During Neoadjuvant Therapy for Patients With Pancreatic Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial tests how well a psychosocial oncology intervention 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 is often recommended prior to surgeryf or patients with pancreatic cancer; this is known as neoadjuvant therapy (NT). The primary advantages of NT include: reducing the size of the cancer mass and/or reducing the spread of cancer, to improve the likelihood of getting all the cancer during surgery, and because receiving chemotherapy after pancreas surgery can be challenging. Other research has shown that NT can lead to improved survival and a lower rate of the cancer returning. Despite these positive effects, NT can be associated with significant physical and emotional side effects. To prepare patients for future surgery and maintain health during chemotherapy and/or radiation, prehabilitation is often recommended. This can include nutritional and physical therapy to help with physical health. An oncology (cancer) psychosocial intervention during NT may be feasible and helpful to patients with localized pancreatic cancer.

Detailed 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 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 receive standard physical therapy and nutritional therapy referrals.

Conditions

• Localized Pancreatic Ductal Adenocarcinoma
• Stage 0 Pancreatic Cancer AJCC v8
• Stage I Pancreatic Cancer AJCC v8
• Stage IIA Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Interview	Ancillary studies
PROCEDURE	Nutritional Therapy	Attend nutritional appointments
PROCEDURE	Physical Therapy	Attend physical therapy appointments
BEHAVIORAL	Psychosocial Care	Receive psychosocial care
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2025-12-22
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-08-15
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States