NCT07124611 · Ohio State University Comprehensive Cancer Center
A Brief Psychological Intervention to Improve Emotional Well-Being During Neoadjuvant Therapy for Pancreatic Cancer
What this study is about
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).
View original scientific description
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults ≥ 18 years of age
- 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
- 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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations