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

NCT ID: NCT07124611

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-10
• Study Completion Date: 2026-12-31

Brief Summary

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.

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 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Health Services Research (psychosocial care)

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.

Group Type: EXPERIMENTAL

Interview

Intervention Type: OTHER

Ancillary studies

Nutritional Therapy

Intervention Type: PROCEDURE

Attend nutritional appointments

Physical Therapy

Intervention Type: PROCEDURE

Attend physical therapy appointments

Psychosocial Care

Intervention Type: BEHAVIORAL

Receive psychosocial care

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Interview

Ancillary studies

Intervention Type: OTHER

Nutritional Therapy

Attend nutritional appointments

Intervention Type: PROCEDURE

Physical Therapy

Attend physical therapy appointments

Intervention Type: PROCEDURE

Psychosocial Care

Receive psychosocial care

Intervention Type: BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Medical Nutrition Therapy; nutrition therapy; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; PT; Psychosocial Support

Eligibility Criteria

Inclusion Criteria

• Adults ≥ 18 years of age
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Jordan Cloyd

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordan M Cloyd, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Central Contacts

The Ohio State University Comprehensive Cancer Center

Role: CONTACT

OSUCCCClinicaltrials@osumc.edu

800-293-5066

Facility Contacts

Jordan M. Cloyd, MD

Role: primary

Jordan.Cloyd@osumc.edu

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2025-05461

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-24234

Identifier Type: -

Identifier Source: org_study_id