This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
532
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.
University of Missouri
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States
Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a
Family caregivers indicate the frequency with which they experience eight different symptoms of anxiety (8 items); higher scores reflect higher anxiety severity.
Time frame: At the time of enrollment, Week 4, and 30-day follow-up
Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a
Family caregivers indicate the frequency with which they experience eight different symptoms of depression (8 items); higher scores reflect higher depression severity
Time frame: At the time of enrollment, Week 4, and 30-day follow-up
Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items)
* 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
Time frame: At the time of enrollment, Week 4, and 30-day follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.