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Recruiting NCT07124611

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

No phase Interventional Localized Pancreatic Ductal Adenocarcinoma Stage 0 Pancreatic Cancer AJCC v8 Stage I Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interview, Nutritional Therapy, Physical Therapy, Psychosocial Care.
Who it may be relevant to
Registry conditions: Localized Pancreatic Ductal Adenocarcinoma, Stage 0 Pancreatic Cancer AJCC v8, Stage I Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Testing the Feasibility of Incorporating Psychosocial Oncology During Neoadjuvant Therapy for Patients With Pancreatic Cancer

Overview

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.

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.

Interventions

  • Other Interview
    Ancillary studies
  • Procedure Nutritional Therapy
    Attend nutritional appointments
  • Procedure Physical Therapy
    Attend physical therapy appointments
  • Behavioral Psychosocial Care
    Receive psychosocial care
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Feasibility and acceptability of the psychosocial oncology intervention [Time frame: Up to 1 year]
Secondary outcome measures (4)
  • Changes in health-related quality of life for patients with hepatobiliary cancer [Time frame: Up to 1 year]
  • Changes in mood for patients with hepatobiliary cancer [Time frame: Up to 1 year]
  • Changes in worry for patients with hepatobiliary cancer [Time frame: Up to 1 year]
  • Changes in uncertainty for patients with hepatobiliary cancer [Time frame: Up to 1 year]

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
  • Already received ≥ 2 cycles of chemotherapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07124611 · OSU-24234 · NCI-2025-05461

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗