Recruiting

Psychosocial Oncology

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07124611

Conditions

Localized Pancreatic Ductal Adenocarcinoma

Stage 0 Pancreatic Cancer AJCC v8

Stage I Pancreatic Cancer AJCC v8

Stage IIA Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interview

Nutritional Therapy

Physical Therapy

Psychosocial Care

Questionnaire Administration

Study Details

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

Study ID

NCT07124611

Start date

Dec 22, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

Interview

Ancillary studies

Nutritional Therapy

Attend nutritional appointments

Physical Therapy

Attend physical therapy appointments

Psychosocial Care

Receive psychosocial care

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Feasibility and acceptability of the psychosocial oncology intervention [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jordan M. Cloyd, MD

Jordan.Cloyd@osumc.edu

Principal Investigator:

Jordan M. Cloyd, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-02-19.