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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage 0 Pancreatic Cancer AJCC v8; Stage I Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Localized Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Interview; Procedure: Nutritional Therapy; Procedure: Physical Therapy; Behavioral: Psychosocial Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Jordan M. Cloyd, MD; Email: Jordan.Cloyd@osumc.edu
      • Principal Investigator: Jordan M. Cloyd, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Already received ≥ 2 cycles of chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Procedure: Nutritional Therapy; Attend nutritional appointments; Other Names: Medical Nutrition Therapy; nutrition therapy; Procedure: Physical Therapy; Attend physical therapy appointments; Other Names: PT; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; Behavioral: Psychosocial Care; Receive psychosocial care; Other Names: Psychosocial Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mood for patients with hepatobiliary cancer	Will be assessed using the Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item instrument used to measure anxiety and depression in medically ill patients frequently used to identify depression in cancer patients. Scores are totaled for both depression and anxiety symptoms and range from 0 to 21 with a higher score indicating worse symptoms. The data will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Differences will be assessed using linear mixed models accounting for within-subject correlations and individual differences.	Up to 1 year
Changes in worry for patients with hepatobiliary cancer	Will be assessed using the Penn State Worry Questionnaire (PSWQ). The PSWQ is a 20-item measure of worry. Scores range from 16 to 80 with higher scores indicative of higher levels of worry. The data will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Differences will be assessed using linear mixed models accounting for within-subject correlations and individual differences.	Up to 1 year
Changes in health-related quality of life for patients with hepatobiliary cancer	Will be assessed using Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G. (FACT-G) is a 27-item questionnaire designed to measure four domains of health related quality of life(HRQOL) in cancer patients: Physical, social, emotional, and functional well-being.. Respondents use a five-point Likert-type scale ranging from 0 to 4, with higher scores reflecting a better quality of life or fewer symptoms. The data will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Differences will be assessed using linear mixed models accounting for within-subject correlations and individual differences.	Up to 1 year
Changes in uncertainty for patients with hepatobiliary cancer	Will be assessed using the Intolerance of Uncertainty Scale (IUS-12) which Measures a component of worry and anxiety associated with discomfort due to the possibility of future events. Respondents use a five-point Likert-type scale ranging from 1 to 5, with higher scores reflecting a higher intolerance of uncertainty in patients. The data will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Differences will be assessed using linear mixed models accounting for within-subject correlations and individual differences.	Up to 1 year

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Jordan M Cloyd, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 8, 2025
• First Submitted That Met QC Criteria: August 8, 2025
• First Posted (Actual): August 15, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Interviews as Topic; Physical Therapy Modalities; Psychiatric Rehabilitation; Nutrition Therapy
• Other Study ID Numbers: OSU-24234; NCI-2025-05461 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No