Localized Pancreatic Ductal Adenocarcinoma, Stage 0 Pancreatic Cancer AJCC v8, Stage I Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8
Conditions
Brief 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.
Interventions
OTHERInterview
Ancillary studies
PROCEDURENutritional Therapy
Attend nutritional appointments
PROCEDUREPhysical Therapy
Attend physical therapy appointments
BEHAVIORALPsychosocial Care
Receive psychosocial care
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and acceptability of the psychosocial oncology intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in health-related quality of life for patients with hepatobiliary cancer | 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. |
| Changes in mood for patients with hepatobiliary cancer | 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. |
| Changes in worry for patients with hepatobiliary cancer | 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. |
| Changes in uncertainty for patients with hepatobiliary cancer | 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORJordan M Cloyd, MD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed