Palliative Care Clinical Trial
Official title:
A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
NCT number | NCT02427490 |
Other study ID # | 2002215 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | May 24, 2017 |
Verified date | October 2021 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. Investigators involved in this mixed methods pilot study will collect and analyze both quantitative and qualitative data, which will subsequently inform a large-scale randomized clinical trial of the problem-solving intervention.
Status | Completed |
Enrollment | 83 |
Est. completion date | May 24, 2017 |
Est. primary completion date | April 29, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older, - access to an Internet-connected device that will support videoconferencing software Exclusion Criteria: - Younger than 18 years of age, - lack of access to an Internet-connected device that will support videoconferencing software |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri Ambulatory Palliative Care Clinic | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in caregiving problems and intensity | Family caregivers select three problems and rate their corresponding distress using a scale of 0-3 where 0 = problem is not at all distressful and 3 = problem is very distressful (3 items). | Upon study enrollment, two weeks, four weeks, eight weeks | |
Primary | Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7) | Family caregivers indicate the frequency with which they experience seven different symptoms of anxiety (7 items); higher scores reflect higher anxiety severity. | Upon study enrollment, two weeks, four weeks, eight weeks | |
Secondary | Change in depression (as measured by the Patient Health Questionnaire - 9) | Family caregivers indicate the frequency with which they experience nine different symptoms of depression (9 items); higher scores reflect higher depression severity. | Upon study enrollment, two weeks, four weeks, eight weeks | |
Secondary | Change in problem-solving approach (as measured by the Problem-Solving Inventory) | Family caregivers indicate the extent to which different statements describing approaches to problem-solving apply to them (25 items). | Upon study enrollment, two weeks, four weeks, eight weeks | |
Secondary | Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised) | Family caregivers complete four items rating their physical, emotional, social, and financial quality of life on a scale of 0-10. | Upon study enrollment, two weeks, four weeks, eight weeks |
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