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

NCT07124611 | Recruiting

• 2 other identifiers: OSU-24234NCI-2025-05461
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability of the psychosocial oncology intervention

  Will be defined as the proportion of enrolled patients who complete the intervention and report that it was acceptable. Will define the incorporation of psychosocial oncology into prehab as feasible and acceptable if \>= 70% of enrolled participants agree.

  Up to 1 year

Secondary Outcomes (4)

• Changes in health-related quality of life for patients with hepatobiliary cancer

  Up to 1 year

• Changes in mood for patients with hepatobiliary cancer

  Up to 1 year

• Changes in worry for patients with hepatobiliary cancer

  Up to 1 year

• Changes in uncertainty for patients with hepatobiliary cancer

  Up to 1 year

Study Arms (1)

Health Services Research (psychosocial care)

EXPERIMENTAL

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.

Other: Interview; Procedure: Nutritional Therapy; Procedure: Physical Therapy; Behavioral: Psychosocial Care; Other: Questionnaire Administration

Interventions

Interview OTHER

Ancillary studies

Health Services Research (psychosocial care)

Physical Therapy PROCEDURE

Attend physical therapy appointments

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Health Services Research (psychosocial care)

Psychosocial Care BEHAVIORAL

Receive psychosocial care

Also known as: Psychosocial Support

Health Services Research (psychosocial care)

Questionnaire Administration OTHER

Ancillary studies

Health Services Research (psychosocial care)

Nutritional Therapy PROCEDURE

Attend nutritional appointments

Also known as: Medical Nutrition Therapy, nutrition therapy

Health Services Research (psychosocial care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Already received ≥ 2 cycles of chemotherapy

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Interviews as Topic; Nutrition Therapy; Physical Therapy Modalities; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jordan M Cloyd, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)