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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252411001 | Other Grant/Funding Number | US Army Medical Research Acquisition Activity (USARAA) |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ePSMI Group | Experimental | Participants in this group will receive the ePSMI intervention for up to ten weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePSMI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Recruited | Will be measured in percentages (%). The study will be considered feasible passed 60%. | Up to 1 year. |
| Percentage of Participants Retained | Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%. | Up to 1 year. |
| Percentage of Study Participation | Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%. | Up to 1 year. |
| Number of Calls | It will be measured by number of biweekly calls. | Up to 10 weeks. |
| Theoretical Framework on Acceptability Questionnaire | Scores will range from 10-50. Higher scores indicate higher acceptability. | 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. | 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 | Up to 10 weeks. |
| Patient-Reported Outcomes Measurement Information System - Fatigue Short Form |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Measured in number of days. | Up to 365 days. |
| Number of Participant's Readmissions | Measured in number of readmissions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Fleszar-Pavlovic, PhD | Contact | 305-243-8498 | sarafleszarpavlovic@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Frank Penedo, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Scores will range 0-80 with higher scores indicating higher fatigue symptoms |
| Up to 10 weeks. |
| Pittsburgh Sleep Quality Index (PSQI) | Scores will range from 0-21 with higher scores indicating worse sleep quality. | Up to 10 weeks. |
| Gastrointestinal Symptom Rating Scale (GSRS) | Scores will range from 0-78 with higher scores indicating worse gastrointestinal symptoms. | Up to 10 weeks. |
| Up to 1 year. |
| Number of Reoccurrence of Disease in Participants | Responses will be binary (yes or no). Will be measured in numbers. | 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 | Up to 1 year. |
| Perceived Stress Scale | Scores will range from 0 to 40 with higher scores indicating greater perceived stress levels. | Up to 10 weeks. |
| University of California, Los Angeles (UCLA) Loneliness Scale | Scale of 20-80 with higher scores indicating higher loneliness | 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 | 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 | 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 | 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 | 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. | 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. | Up to 10 weeks. |
| Difficulties in Emotional Regulation Scale | Scores will range from 18-90 with higher scores indicating less emotional regulation. | Up to 10 weeks. |
| Intolerance of Uncertainty Scale | Scores will range from 27-135 with higher scores indicated greater intolerance of uncertainties. | Up to 10 weeks. |
| Cancer Behavior Inventory | Scores will range from 33-297 with higher scores indicating greater self-efficacy in coping with cancer. | 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. | 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. | Up to 10 weeks. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |