The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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.
University of Miami
Miami, Florida, United States
RECRUITINGPercentage of Participants Recruited
Will be measured in percentages (%). The study will be considered feasible passed 60%.
Time frame: Up to 1 year.
Percentage of Participants Retained
Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.
Time frame: Up to 1 year.
Percentage of Study Participation
Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.
Time frame: Up to 1 year.
Number of Calls
It will be measured by number of biweekly calls.
Time frame: Up to 10 weeks.
Theoretical Framework on Acceptability Questionnaire
Scores will range from 10-50. Higher scores indicate higher acceptability.
Time frame: Up to 10 weeks.
Functional Assessment of Cancer Therapy (FACT) - Functional Hepatobiliary-Pancreatic Symptom Index (FHSI)-18
Scores will range 0-72 with lower scores indicating better quality of life.
Time frame: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Pain Short Form
Scores will range 0-80 with higher scores indicating higher pain symptoms
Time frame: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Fatigue Short Form
Scores will range 0-80 with higher scores indicating higher fatigue symptoms
Time frame: Up to 10 weeks.
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Pittsburgh Sleep Quality Index (PSQI)
Scores will range from 0-21 with higher scores indicating worse sleep quality.
Time frame: Up to 10 weeks.
Gastrointestinal Symptom Rating Scale (GSRS)
Scores will range from 0-78 with higher scores indicating worse gastrointestinal symptoms.
Time frame: Up to 10 weeks.
Length of Hospital Stay
Measured in number of days.
Time frame: Up to 365 days.
Number of Participant's Readmissions
Measured in number of readmissions.
Time frame: Up to 1 year.
Number of Reoccurrence of Disease in Participants
Responses will be binary (yes or no). Will be measured in numbers.
Time frame: Up to 1 year.
Progression of Disease
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
Time frame: Up to 1 year.
Perceived Stress Scale
Scores will range from 0 to 40 with higher scores indicating greater perceived stress levels.
Time frame: Up to 10 weeks.
University of California, Los Angeles (UCLA) Loneliness Scale
Scale of 20-80 with higher scores indicating higher loneliness
Time frame: Up tp 10 weeks.
Interpersonal Support Evaluation List
12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support
Time frame: Up tp 10 weeks.
Patient-Reported Outcomes Measurement Information System - Depression Short Form
Scores will range 0-80 with higher scores indicating higher pain symptoms
Time frame: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Anxiety Short Form
Scores will range 0-80 with higher scores indicating higher pain symptoms
Time frame: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Physical Functioning Short Form
Scores will range 0-80 with higher scores indicating higher pain symptoms
Time frame: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Self- Efficacy for Managing Symptoms-Short Form 8a
Scores will range 8-40 with greater scores indicating greater self- efficacy for managing symptoms.
Time frame: Up to 10 weeks.
Emotional distress measured by Measure of Current State Scale
Scores will range from 0-80 with higher scores indicating more intense emotional distress.
Time frame: Up to 10 weeks.
Difficulties in Emotional Regulation Scale
Scores will range from 18-90 with higher scores indicating less emotional regulation.
Time frame: Up to 10 weeks.
Intolerance of Uncertainty Scale
Scores will range from 27-135 with higher scores indicated greater intolerance of uncertainties.
Time frame: Up to 10 weeks.
Cancer Behavior Inventory
Scores will range from 33-297 with higher scores indicating greater self-efficacy in coping with cancer.
Time frame: Up to 10 weeks.
Emotional Bond subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)
Scores will range from, 5-25; higher scores indicate greater emotional connection between the therapist and patient.
Time frame: Up to 10 weeks.
Agreement of Collaboration Subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)
Scores will range from, 5-25; higher scores indicate greater agreement on collaboration between the therapist and patient.
Time frame: Up to 10 weeks.