Psychological Adaptation, Psychological Adjustment, Stress, Emotional
Conditions
Keywords
Psychosocial Symptom Management, eHealth Intervention
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
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.
BEHAVIORALStandard Education
Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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. Willingness to be assessed at diagnosis, during neoadjuvant chemotherapy (if applicable), preoperatively (if applicable - unless time of diagnosis is preoperative visit), and postoperatively for up to two years following surgery.
Exclusion criteria
1. Patients unable to read Spanish or English, as they will be unable to complete surveys. 2. History of previous invasive cancer or treatment with chemotherapy, as they may have a different baseline functional status, quality of life, and gastrointestinal function compared to the normal healthy population, per principal investigator discretion, based on a case-by-case review. 3. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months as these conditions can interfere with adequate participation in assessments, per principal investigator discretion, based on a case-by-case review. 4. 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 |
|---|---|---|
| Health Related Quality of Life as Measured by Perceived Stress Scale | Up to 10 weeks. | Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress) |
| Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale | Up to 10 weeks. | UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness) |
| Health Related Quality of Life as Measured by Interpersonal Support Evaluation List | Up to 10 weeks. | Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support). |
| Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7) | Up to 10 weeks. | FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life) |
| Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18 | Up to 10 weeks. | FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life) |
| The Gastrointestinal Symptom Rating Scale (GSRS) | Up to 10 weeks. | GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms) |
Countries
United States
Outcome results
None listed