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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-05461 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Services Research (psychosocial care) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Ancillary studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in health-related quality of life for patients with hepatobiliary cancer | 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. |
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Inclusion Criteria:
Adults ≥ 18 years of age
Patient:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jordan M Cloyd, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Nutritional Therapy |
| Procedure |
Attend nutritional appointments |
|
|
| Physical Therapy | Procedure | Attend physical therapy appointments |
|
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| Psychosocial Care | Behavioral | Receive psychosocial care |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Up to 1 year |
| Changes in mood for patients with hepatobiliary cancer | 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. | Up to 1 year |
| Changes in worry for patients with hepatobiliary cancer | 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. | Up to 1 year |
| Changes in uncertainty for patients with hepatobiliary cancer | 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. | Up to 1 year |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D044623 | Nutrition Therapy |
| D026741 | Physical Therapy Modalities |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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