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2025-09-01
2026-12-31
2026-12-31
25
NCT07124611
Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
INTERVENTIONAL
A Brief Psychological Intervention to Improve Emotional Well-Being During Neoadjuvant Therapy for Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-08-08 | N/A | 2025-08-08 |
2025-08-08 | N/A | 2025-08-15 |
2025-08-15 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Health Services Research
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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 appoint | OTHER: Interview
PROCEDURE: Nutritional Therapy
PROCEDURE: Physical Therapy
BEHAVIORAL: Psychosocial Care
OTHER: Questionnaire Administration
|
| Primary Outcome Measures | 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 | Measure Description | Time Frame |
|---|---|---|
| Changes in health-related quality of life for patients with hepatobiliary cancer | Will be assessed using Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep). FACT-Hep consists of the 27-item FACT-G, which assesses generic HRQL concerns, and a validated 18-item Hepatobiliary Subscale (HS), which assesses disease-specific issues. 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 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 uncertainty for patients with hepatobiliary cancer | Will be assessed using the Intolerance of Uncertainty Scale (IUS) 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: The Ohio State University Comprehensive Cancer Center Phone Number: 800-293-5066 Email: OSUCCCClinicaltrials@osumc.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
