Outcomes of Triaged Family Care in Advanced Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Advanced Cancer
- Sponsor
- University of Michigan
- Enrollment
- 484
- Locations
- 5
- Primary Endpoint
- Change in Quality of Life
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.
Detailed Description
The purpose of this study is to: 1. determine if family dyads randomly assigned to either a brief or extensive family-based program of care have better proximal and distal outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care 2. determine if the brief or extensive program of care has a differential effect on patient and caregiver outcomes depending on the patient's baseline risk for distress status (high versus low). A longitudinal, randomized clinical trial is being used for patients with advanced lung, colorectal, prostate, and breast cancer and their caregivers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with Stage 3 or 4 breast, prostate, colorectal and lung cancers.
- •Patients must be 21 years old or older, physically and mentally able to participate, speak and understand English, have a minimum life expectancy of six months, live within 75 miles of one of the participating sites and have a family caregiver who is willing to participate in the study.
- •For this study "family caregiver" is defined as the person who provides the patient with physical and/or emotional support during cancer treatment.
- •Family caregivers must be 18 years old or older, physically and mentally able to participate, and speak and understand English.
Exclusion Criteria
- •Patients will be excluded if they have multiple primary cancer sites.
- •Family caregivers will be excluded if they, themselves, have been diagnosed with cancer during the previous year and/or are in active treatment for cancer.
Outcomes
Primary Outcomes
Change in Quality of Life
Time Frame: Baseline, 3 and 6 months
Secondary Outcomes
- Change in Health Care Resource Utilization(Baseline, 3 and 6 months)
- Change in Caregiver Burden(Baseline, 3 and 6 months)
- Change in Emotional Distress(Baseline, 3 and 6 months)
- Change in Uncertainty(Baseline, 3 and 6 months)
- Change in Hopelessness(Baseline, 3 and 6 months)
- Change in Benefits of Illness(Baseline, 3 and 6 months)
- Change in Depression(Baseline, 3 and 6 months)
- Risk for Distress(Baseline)
- Change in Coping(Baseline, 3 and 6 months)
- Change in Appraisal of Illness/Caregiving(Baseline, 3 and 6 months)
- Change in Self-efficacy(Baseline, 3 and 6 months)
- Change in Family Communication(Baseline, 3 and 6 months)
- Change in Support(Baseline, 3 and 6 months)