Not provided
Not provided
Not provided
Not provided
Not provided
We have decided to withdraw this research study due to the receipt of funding for a similar study that aligns more closely with our current research priorities and available resources.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm | Experimental | Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period. |
|
| Usual Clinical Care Control Arm | Active Comparator | Participants in this group will receive standard education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT)-based skills | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life as Measured by Perceived Stress Scale | Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress) | Up to 10 weeks. |
| Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale | UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness) | Up to 10 weeks. |
| Health Related Quality of Life as Measured by Interpersonal Support Evaluation List | Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support). | Up to 10 weeks. |
| Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7) | FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life) | Up to 10 weeks. |
| Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18 | FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life) | Up to 10 weeks. |
| The Gastrointestinal Symptom Rating Scale (GSRS) | GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms) | Up to 10 weeks. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Education | Behavioral | Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer. |
|