A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
- Conditions
- Palliative CareMedical OncologyCaregivers
- Interventions
- Other: Unenhanced MonitoringBehavioral: Problem-Solving Intervention
- Registration Number
- NCT02427490
- Lead Sponsor
- University of Missouri-Columbia
- Brief Summary
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.
- Detailed Description
Palliative oncology providers are ideally situated to improve the cancer journey for the millions of family members and friends who are vital to the care of seriously ill patients. In recent decades, the primary setting for cancer care has shifted from the hospital inpatient unit to the outpatient clinic, leaving family caregivers responsible for providing the majority of patient care in the home, often with little support or preparation. The numerous stressors associated with family caregiving often give rise to caregiver anxiety, depression, fatigue, neglect of self-care and, for particularly strained caregivers, psychological symptoms that mirror those experienced by trauma survivors. 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. Specifically, the investigators aim to 1) examine the feasibility of the intervention relative to recruitment, randomization, retention, and fidelity to core intervention components; 2) investigate the impact of the intervention on family caregiver anxiety, depression, and quality of life; and 3) explore the benefits and challenges associated with the intervention from the perspective of participants. To accomplish these aims, investigators will recruit and randomly assign 82 family caregivers of cancer patients receiving outpatient palliative care into two groups (usual care and intervention) and collect quantitative and qualitative data, which will be analyzed to inform a future large-scale randomized clinical trial of the problem-solving intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 18 years of age or older,
- access to an Internet-connected device that will support videoconferencing software
- Younger than 18 years of age,
- lack of access to an Internet-connected device that will support videoconferencing software
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unenhanced Monitoring Unenhanced Monitoring Family caregivers of cancer patients receiving outpatient palliative care will complete standardized questionnaires at the time of study enrollment and two, four, and eight weeks after study enrollment. Problem-Solving Intervention Unenhanced Monitoring Family caregivers of cancer patients receiving outpatient palliative care will use videoconferencing tools to participate in three problem-solving sessions with a member of the research team. Problem-Solving Intervention Problem-Solving Intervention Family caregivers of cancer patients receiving outpatient palliative care will use videoconferencing tools to participate in three problem-solving sessions with a member of the research team.
- Primary Outcome Measures
Name Time Method Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7) Upon study enrollment, two weeks, four weeks, eight weeks Family caregivers indicate the frequency with which they experience seven different symptoms of anxiety (7 items); higher scores reflect higher anxiety severity.
- Secondary Outcome Measures
Name Time Method Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised) Upon study enrollment, two weeks, four weeks, eight weeks Family caregivers complete four items rating their physical, emotional, social, and financial quality of life on a scale of 0-10.
Change in depression (as measured by the Patient Health Questionnaire - 9) Upon study enrollment, two weeks, four weeks, eight weeks Family caregivers indicate the frequency with which they experience nine different symptoms of depression (9 items); higher scores reflect higher depression severity.
Change in problem-solving approach (as measured by the Problem-Solving Inventory) Upon study enrollment, two weeks, four weeks, eight weeks Family caregivers indicate the extent to which different statements describing approaches to problem-solving apply to them (25 items).
Trial Locations
- Locations (1)
University of Missouri Ambulatory Palliative Care Clinic
🇺🇸Columbia, Missouri, United States