Psychological Intervention for Pancreatic Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Prisoners, Unable to consent, Metastatic, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether meeting with a psychologist during treatment can improve emotional and physical well-being for individuals with localized pancreatic cancer as they prepare for surgery. The trial combines mental health support (psychosocial care) with standard pre-surgery preparations, such as exercise and nutrition advice. Participants will have weekly telehealth sessions with a psychologist while also engaging in physical and dietary therapy. This trial may suit those newly diagnosed with localized pancreatic cancer who plan to begin treatment before surgery. As an unphased trial, it offers a unique opportunity to enhance overall well-being with comprehensive support in preparation for surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this psychosocial care intervention is safe for patients with localized pancreatic cancer?

Research has shown that meeting with a psychologist can be safe and helpful for cancer patients. Psychological support before surgery has been linked to better outcomes in various cancer groups and is generally well-received.

This clinical trial focuses on providing psychological support during treatment before surgery for pancreatic cancer. Studies have shown that patients with different types of cancer have responded well to similar support. Typically, these meetings with a psychologist occur through telehealth, offering a low-risk option.

Overall, this care aims to reduce stress and improve emotional well-being. No major negative effects have been reported, making it a promising option for patients seeking to enhance their treatment experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the psychosocial care treatment for pancreatic cancer because it focuses on mental and emotional support, which is often overlooked in standard treatments like surgery, chemotherapy, and radiation. This approach involves meeting with a psychologist through telehealth sessions, providing convenience and accessibility for patients. By addressing psychological well-being alongside physical health, this intervention aims to improve overall quality of life, making it a promising complement to traditional medical treatments.

What evidence suggests that this psychosocial care is effective for pancreatic cancer?

Research has shown that psychological support before surgery can lead to better outcomes for cancer patients. One study found that patients who received psychological help before surgery experienced overall improvement. Another study demonstrated that early psychological support in treatment enhanced patients' quality of life. In this trial, participants will receive psychosocial care through telehealth sessions with a psychologist, which may help manage stress and improve recovery chances. This approach aims to provide support during treatments like chemotherapy or radiation, potentially helping patients feel more supported and prepared for surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Jordan M Cloyd, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with localized pancreatic cancer who are undergoing neoadjuvant therapy (chemo and/or radiation before surgery). They should be able to participate in physical and nutritional therapy, psychosocial care, and interviews. Specific eligibility details were not provided.

Inclusion Criteria

I am 18 years old or older.

I am planning to start treatment before surgery to remove my tumor.

I had or will have initial cancer treatment or surgery at another facility.

Exclusion Criteria

I am unable to give consent by myself.

My cancer has spread to other parts of my body.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Therapy

Participants undergo chemotherapy and/or radiation therapy prior to surgery, including psychosocial oncology intervention with weekly telehealth sessions for 4 weeks

4 weeks

4 visits (virtual)

Prehabilitation

Participants attend standard physical therapy and nutritional therapy appointments to prepare for surgery

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Psychosocial Care

Trial Overview The trial tests a psychological intervention combined with standard prehabilitation (exercise and nutrition support) during neoadjuvant therapy. It aims to improve emotional well-being and prepare patients physically for upcoming surgery.

How Is the Trial Designed?

Group I: Health Services Research (psychosocial care) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12591962/

Impact of preoperative psychological support on outcomes in ... Preoperative multidisciplinary psychological support (PMPS) has been associated with improved outcomes in several cancer populations, ...

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13891-w

The psychosocial impact of pancreatic cancer on caregivers Pancreatic cancer caregivers experience negative psychosocial impacts, exacerbated by the disease's trajectory.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469056/

Evaluation of Distress 3 Years After Enrollment Following 3 years of surveillance for PC pancreatic cancer, 67% of the overall study population—comprising both the Stable Clinical Stress group ...

4. nature.com nature.com/articles/s41598-024-63431-y

Psychological intervention improves quality of life in ... The results for the cancer stage suggest that psychological interventions are most effective when provided in the early stages rather than in ...

5. esmoopen.com esmoopen.com/article/S2059-7029(24)01262-6/fulltext

results of a multicenter non-randomized controlled trial A distress reduction at the family level according to the defined MID of ≥1.6 was achieved significantly more frequently in the IG. In the IG, ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14365-9

The impact of distress at diagnosis in patients with pancreatic ... More than 70% of the patients had moderate to severe distress at diagnosis. Distress was associated with increased risk of major complications after ...

7. facingourrisk.org facingourrisk.org/XRAY/emotional-healthcare-for-hereditary-pancreatic-cancer-risk

Screening and mental healthcare for high risk of pancreatic ... A 2024 study evaluated the responses of 100 individuals at increased risk for pancreatic cancer before and after undergoing surveillance. While ...

8. mdpi.com mdpi.com/2072-6694/16/1/86

Assessment of the Psychosocial Impact of Pancreatic ... This study explores the psychosocial impact of pancreatic cancer (PC) surveillance in individuals at high-risk (HRIs) of developing PC.

9. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2814979

Implementation of Best Practices in Pancreatic Cancer ... In this Dutch multicenter, stepped-wedge randomized clinical trial including 5887 patients, 1-year survival was 24% after implementation of 5 best practices ...