A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

Conditions
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Palliative Care, Caregivers, Medical Oncology

Intervention / Treatment
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* Behavioral: Problem-Solving Intervention
* Other: Unenhanced Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unenhanced Monitoring<br>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. | Other: Unenhanced Monitoring<br>* Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.<br>* Other names: Unenhanced Monitoring of Behavioral Health Outcomes;|
| Experimental: Problem-Solving Intervention<br>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. | Behavioral: Problem-Solving Intervention<br>* The problem-solving approach that will be taught in the problem-solving intervention is based on the ADAPT model, which encourages participants to follow five steps when solving problems: focus on adopting a positive attitude to problem-solving, define the problem and set goals, generate a list of alternative solutions to the problem, predict consequences of the alternative solutions, and try implementing the most promising solution from among the list of alternatives. The problem-solving intervention will be delivered by a trained interventionist in three structured sessions using videoconferencing tools.<br>* Other names: Problem-Solving Intervention for Family Caregivers;Other: Unenhanced Monitoring<br>* Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.<br>* Other names: Unenhanced Monitoring of Behavioral Health Outcomes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Caregivers, Medical Oncology