Outcomes of Triaged Family Care in Advanced Cancer
- Conditions
- Advanced Cancer
- Interventions
- Behavioral: Brief FOCUS ProgramBehavioral: Extensive FOCUS Program
- Registration Number
- NCT00709176
- Lead Sponsor
- University of Michigan
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 484
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief Brief FOCUS Program Dyads randomized to BRIEF arm received the Brief FOCUS Program (two home visits and one phone call by a trained nurse) in addition to standard clinical care. Extensive Extensive FOCUS Program Dyads randomized to EXTENSIVE arm received the Extensive FOCUS Program (4 home visits and two phone calls by a trained nurse) in addition to standard clinical care.
- Primary Outcome Measures
Name Time Method Change in Quality of Life Baseline, 3 and 6 months
- Secondary Outcome Measures
Name Time Method 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 Change in Health Care Resource Utilization Baseline, 3 and 6 months Change in Caregiver Burden Baseline, 3 and 6 months
Trial Locations
- Locations (5)
Providence Hospital Cancer Institute
🇺🇸Southfield, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
St. Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Wayne State University
🇺🇸Detroit, Michigan, United States