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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: 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:
    • Physiatric Procedure
    • Physical Medicine Procedure
    • Physical Therapeutics
    • Physical Therapy Procedure
    • Physiotherapy
    • Physiotherapy Procedure
    • PT
  • Behavioral: Psychosocial Care
    Receive psychosocial care
    Other names:
    • Psychosocial Support
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
Contact:
Jordan M. Cloyd, MD
Jordan.Cloyd@osumc.edu

More Details

Status
Recruiting
Sponsor
Ohio State University Comprehensive Cancer Center

Study Contact

The Ohio State University Comprehensive Cancer Center
800-293-5066
OSUCCCClinicaltrials@osumc.edu

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.