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RecruitingInterventional

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

NCT ID: NCT07124611Sponsor: Ohio State University Comprehensive Cancer CenterLast updated: 2026-02-19

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.

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.

Arms & interventions

  • OtherInterview

    Ancillary studies

  • ProcedureNutritional Therapy

    Attend nutritional appointments

  • ProcedurePhysical Therapy

    Attend physical therapy appointments

  • BehavioralPsychosocial Care

    Receive psychosocial care

  • OtherQuestionnaire Administration

    Ancillary studies

Outcome measures

Primary

  • 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.

    Time frame: Up to 1 year

Secondary

  • 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

Sex: AllAge: 18 Years and olderHealthy 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 * Already received ≥ 2 cycles of chemotherapy

Study locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Jordan M. Cloyd, MD · Contact
Jordan M. Cloyd, MD · Principal Investigator
A Brief Psychological Intervention to Improve Emotional Well-Being During Neoadjuvant Therapy for Pancreatic Cancer | Cancerify