Pancreatic Cancer
Conditions
Brief summary
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
Interventions
BEHAVIORALePSMI
Participants will complete an hour of cognitive behavioral stress management program in person or remote each week for ten weeks. The cognitive behavioral therapy (CBT) skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour. After module completion, participants will have access to modules covered during session.
Sponsors
University of Miami
U.S. Army Medical Research and Development Command
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Greater than 18 years of age. 2. Spanish or English speaker with ability to read one of these languages. 3. Diagnosis of pancreatic cancer. 4. Patients diagnosed with pancreatic neuroendocrine tumor (PNET).
Exclusion criteria
1. Patients unable to read Spanish or English, as participants will not be unable to complete surveys. 2. Have a history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months). 3. Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System - Fatigue Short Form | Up to 10 weeks. | Scores will range 0-80 with higher scores indicating higher fatigue symptoms |
| Pittsburgh Sleep Quality Index (PSQI) | Up to 10 weeks. | Scores will range from 0-21 with higher scores indicating worse sleep quality. |
| Gastrointestinal Symptom Rating Scale (GSRS) | Up to 10 weeks. | Scores will range from 0-78 with higher scores indicating worse gastrointestinal symptoms. |
| Patient-Reported Outcomes Measurement Information System - Pain Short Form | Up to 10 weeks. | Scores will range 0-80 with higher scores indicating higher pain symptoms |
| Percentage of Participants Recruited | Up to 1 year. | Will be measured in percentages (%). The study will be considered feasible passed 60%. |
| Percentage of Participants Retained | Up to 1 year. | Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%. |
| Percentage of Study Participation | Up to 1 year. | Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%. |
| Number of Calls | Up to 10 weeks. | It will be measured by number of biweekly calls. |
| Theoretical Framework on Acceptability Questionnaire | Up to 10 weeks. | Scores will range from 10-50. Higher scores indicate higher acceptability. |
| Functional Assessment of Cancer Therapy (FACT) - Functional Hepatobiliary-Pancreatic Symptom Index (FHSI)-18 | Up to 10 weeks. | Scores will range 0-72 with lower scores indicating better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System - Depression Short Form | Up to 10 weeks. | Scores will range 0-80 with higher scores indicating higher pain symptoms |
| Patient-Reported Outcomes Measurement Information System - Anxiety Short Form | Up to 10 weeks. | Scores will range 0-80 with higher scores indicating higher pain symptoms |
| Patient-Reported Outcomes Measurement Information System - Physical Functioning Short Form | Up to 10 weeks. | Scores will range 0-80 with higher scores indicating higher pain symptoms |
| Patient-Reported Outcomes Measurement Information System - Self- Efficacy for Managing Symptoms-Short Form 8a | Up to 10 weeks. | Scores will range 8-40 with greater scores indicating greater self- efficacy for managing symptoms. |
| Emotional distress measured by Measure of Current State Scale | Up to 10 weeks. | Scores will range from 0-80 with higher scores indicating more intense emotional distress. |
| Difficulties in Emotional Regulation Scale | Up to 10 weeks. | Scores will range from 18-90 with higher scores indicating less emotional regulation. |
| Intolerance of Uncertainty Scale | Up to 10 weeks. | Scores will range from 27-135 with higher scores indicated greater intolerance of uncertainties. |
| Cancer Behavior Inventory | Up to 10 weeks. | Scores will range from 33-297 with higher scores indicating greater self-efficacy in coping with cancer. |
| Emotional Bond subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P) | Up to 10 weeks. | Scores will range from, 5-25; higher scores indicate greater emotional connection between the therapist and patient. |
| Agreement of Collaboration Subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P) | Up to 10 weeks. | Scores will range from, 5-25; higher scores indicate greater agreement on collaboration between the therapist and patient. |
| Length of Hospital Stay | Up to 365 days. | Measured in number of days. |
| Number of Participant's Readmissions | Up to 1 year. | Measured in number of readmissions. |
| Number of Reoccurrence of Disease in Participants | Up to 1 year. | Responses will be binary (yes or no). Will be measured in numbers. |
| Progression of Disease | Up to 1 year. | Stages range from 0 to 4. Stage 0: carcinoma in situa Stage 1: localized Stage II: locally advanced Stage III: locally advanced with major blood vessel involvement Stage IV: Metastatic |
| Perceived Stress Scale | Up to 10 weeks. | Scores will range from 0 to 40 with higher scores indicating greater perceived stress levels. |
| University of California, Los Angeles (UCLA) Loneliness Scale | Up tp 10 weeks. | Scale of 20-80 with higher scores indicating higher loneliness |
| Interpersonal Support Evaluation List | Up tp 10 weeks. | 12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support |
Countries
United States
Contacts
CONTACTSara Fleszar-Pavlovic, PhD
PRINCIPAL_INVESTIGATORFrank Penedo, PhD
University of Miami
Outcome results
None listed