Cancer Clinical Trial
Official title:
Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
Informal caregivers provide a majority of care for patients at the end of life. Lack of end
of life preparation and completion may leave caregivers less capable of caring for a loved
one or making crucial decisions influencing care.
This study will examine whether a preparation and completion intervention reduces caregiver
anxiety, depression, anticipatory grief, and burden and improves patient quality of life and
health care use
The investigators propose a randomized control trial to evaluate an intervention of
end-of-life preparation and completion with Veterans and their caregivers at end-of-life.
Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on
caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the
impact of the home versus in hospital, emergency department, or nursing facility; 3)
Evaluate the impact of the intervention session's qualitative content, examining variation
associated with selected demographic variables, quality of family communication, and stage
of illness on change.
Caregivers in the first group ("treatment") will meet with a facilitator three times for a
period of forty-five minutes each. In the first session, subjects will be asked to discuss
issues related to relationship life review.
In session two, participants will be asked to speak in more depth about issues such as
regret and forgiveness. In the final session, subjects will focus on legacy and celebration.
Caregivers in the second group ("attention control") will meet with a facilitator three
times for a period of forty-five minutes each and be asked to listen to a non-guided
relaxation CD or participate in a guided relaxation exercise.
Participants in both groups will receive pre and post-test measures administered by a
blinded interviewer. Outcome measures will be measures by the Functional Assessment of
Cancer Therapy - General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory
Grief Scale, Caregiver Reaction Assessment, the Qual-E completion and preparation
sub-scales, and patient days at home.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Supportive Care
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