Outcomes of Triaged Family Care in Advanced Cancer

University of Michigan484 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

484

Conditions

Advanced Cancer

Interventions

Brief FOCUS ProgramBEHAVIORAL

Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.

Extensive FOCUS ProgramBEHAVIORAL

Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

St. Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Wayne State University

Detroit, Michigan, United States