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NCT Number: NCT07124611

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 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Jordan M. Cloyd, MD

CONTACT

[email protected]

Jordan M. Cloyd, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Ancillary studies

Nutritional Therapy

Procedure

Attend nutritional appointments

Other names: Medical Nutrition Therapy, nutrition therapy

physical therapy

Procedure

Attend physical therapy appointments

Other names: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Psychosocial Care

Behavioral

Receive psychosocial care

Other names: Psychosocial Support

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility and acceptability of the psychosocial oncology intervention

    Time frame: Up to 1 year

    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.

Secondary outcomes

  1. Changes in health-related quality of life for patients with hepatobiliary cancer

    Time frame: Up to 1 year

    Will be assessed using Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G. (FACT-G) is a 27-item questionnaire designed to measure four domains of health related quality of life(HRQOL) in cancer patients: Physical, social, emotional, and functional well-being.. 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.

  2. Changes in mood for patients with hepatobiliary cancer

    Time frame: Up to 1 year

    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.

  3. Changes in worry for patients with hepatobiliary cancer

    Time frame: Up to 1 year

    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.

  4. Changes in uncertainty for patients with hepatobiliary cancer

    Time frame: Up to 1 year

    Will be assessed using the Intolerance of Uncertainty Scale (IUS-12) 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.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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