Depression, Anxiety, Palliative Care, Caregivers, Cancer
Conditions
Brief summary
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.
Detailed description
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care. Study participants will be randomized to receive either a three-session problem-solving therapy intervention in addition to usual care or three sessions of attention-matched control in addition to usual care.
Interventions
Over an approximately 3-week period, family caregivers randomized to the intervention study arm will learn and apply a problem-solving approach based on the ADAPT model, which encourages participants to follow five steps when solving caregiving problems: 1) focus on adopting a positive attitude to problem solving, 2) define the problem and set goals, 3) generate a list of alternative solutions to the problem, 4) predict consequences of the alternative solutions, and 5) try implementing the most promising solution from among the list of alternatives. The intervention will be delivered by a trained interventionist over the course of three structured sessions via telephone or videoconferencing technology, depending on the FCG's preference. Session content will be summarized in an intervention manual, which we will provide to all intervention participants. Sessions will last approximately 45-60 minutes.
Over an approximately 3-week period, family caregivers randomized to the attention control study arm will participate in informal conversations (friendly visits) with a trained member of the research team.
The 30 key stakeholders interviews will discuss how the PST intervention fits into existing clinical practice and institutional values, what might incentivize adoption of the PST intervention, and how the intervention compares to alternative existing or proposed programs.
Sponsors
Study design
Intervention model description
The randomized portion of the trial will enroll 540 family caregivers. An additional portion of the trial will enroll 30 key stakeholders to participate in individual interviews focused on potential barriers and facilitators to adoption of the problem-solving therapy (PST) intervention into clinical practice.
Eligibility
Inclusion criteria
for Family Caregivers (FCGs) * Must be 18 years of age or older * Must serve as the unpaid family caregiver of a patient with cancer receiving outpatient palliative care from one of the participating clinical sites. As is common in caregiving research, we will define family caregiver as anyone substantially involved in a patient's care on an unpaid basis; a legal or biological relationship will not be required * Must consent to participate Inclusion Criteria for Non-Family Caregiver Stakeholders * Must be 18 years of age or older * Must be employed by or affiliated with the healthcare system housing one of the participating clinical sites. * Must consent to participate.
Exclusion criteria
for Family Caregivers (FCGs) * Younger than 18 years of age * Paid caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a | At the time of enrollment, Week 4, and 30-day follow-up | Family caregivers indicate the frequency with which they experience eight different symptoms of anxiety (8 items); higher scores reflect higher anxiety severity. |
| Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a | At the time of enrollment, Week 4, and 30-day follow-up | Family caregivers indicate the frequency with which they experience eight different symptoms of depression (8 items); higher scores reflect higher depression severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items) | At the time of enrollment, Week 4, and 30-day follow-up | * Family caregivers indicate good things that they experience as a caregiver with seven different statements. The caregivers answer with 1=I disagree with this statement a lot; 2=I disagree with this statement a little; 3=I neither agree nor disagree with this statement; 4=I agree with this statement a little; or 5=I agree with this statement a lot. * Higher scores indicate a more positive caregiving experience |
Countries
United States