Feasibility and Acceptability of Integrating Family Caregiver Support Into Cancer Clinical Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Absolute change in the Caregiver Reaction Assessment (CRA) score
Study Overview
Brief Summary
The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system.
Detailed Description
The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system. This study will allow us to examine the benefit of adding a personalized support program for the family caregiver of a patients participating in a cancer clinical trial. Findings will assist in strengthening patient/caregiver-centered care management and support programs developed to enhance the quality of life of patients with cancer and the caregivers, reduce barriers to clinical recruitment, and improve retention in clinical trials.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •dyad must be at least 18 years of age,
- •patient is enrolled or expressed intent to enroll in a therapeutic cancer clinical trial
- •caregiver is a self-identified primary caregiver,
- •able to speak, read, and understand English,
- •willing to participate in completion of surveys, and
- •co-residence
Exclusion Criteria
- Not provided
Arms & Interventions
Patient-caregiver dyads
Dyads will include family caregivers and patients with a diagnosis of cancer who agreed to participate in a therapeutic clinical trial.
Intervention: Benjamin Rose Institute (BRI) Care Consultation™ Program (Behavioral)
Outcomes
Primary Outcomes
Absolute change in the Caregiver Reaction Assessment (CRA) score
Time Frame: 1 year
Caregiver Reaction Assessment (CRA) will be used to measure caregiver burden. The instrument was designed as a questionnaire with Likert-type responses ranging from strongly agree (1) to strongly disagree. The 24 items form 5 distinct unidimensional subscales that include: family burden (lack of family support; 5 items), financial burden (struggle with bills; 3 items), health burden (caregivers' health decline; 4 items), schedule burden (disruption of daily tasks; 5 items), and caregiving esteem (7 items), a positive subscale that measures enjoyment and importance of caregiving. A higher score on the caregiver's esteem subscale indicates a more positive effect of caregiving while higher scores on the other subscales indicate greater negative effects of caregiving in those domains
Absolute change in the scores for the assessment domains included in the Ben Rose Institute (BRI) care consultation program
Time Frame: 1 year
Assessment of multiple caregiver and patient domains addressed by the BRI Care Consultation program
Secondary Outcomes
- Absolute change in the Functional Assessment of Cancer Therapy - General (FACT-G) score(1 year)
- Absolute change in Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events (PRO-CTCAE) scores(1 year)