Advanced Cancer
Conditions
Keywords
Quality of Life, Randomized Clinical Trial, Advanced Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Family caregiver, cancer survivorship, coping, communication, uncertainty, support, depression, self-efficacy, benefits of illness, Caregivers
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.
Interventions
BEHAVIORALBrief FOCUS Program
Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.
BEHAVIORALExtensive FOCUS Program
Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.
Sponsors
Wayne State University
National Cancer Institute (NCI)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Quality of Life | Baseline, 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Coping | 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 |
| Risk for Distress | Baseline |
| Change in Emotional Distress | Baseline, 3 and 6 months |
| Change in Appraisal of Illness/Caregiving | Baseline, 3 and 6 months |
| Change in Depression | Baseline, 3 and 6 months |
| Change in Hopelessness | Baseline, 3 and 6 months |
| Change in Self-efficacy | Baseline, 3 and 6 months |
| Change in Benefits of Illness | Baseline, 3 and 6 months |
| Change in Family Communication | Baseline, 3 and 6 months |
| Change in Support | Baseline, 3 and 6 months |
| Change in Uncertainty | Baseline, 3 and 6 months |
Countries
United States
Outcome results
None listed