Outcomes of Triaged Family Care in Advanced Cancer (FOCUS-Triage)

University of Michigan

Status: Completed

Conditions: Advanced Cancer

Treatments: Behavioral: Brief FOCUS Program; Behavioral: Extensive FOCUS Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00709176

UMCC 2003-094 (Other Identifier)

R01CA107383 (U.S. NIH Grant/Contract)

IRBMED No. 2004-0129 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 484 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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484 participants in 3 patient groups

Brief

Experimental group

Description:

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.

Treatment:

Behavioral: Brief FOCUS Program

Extensive

Experimental group

Description:

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.

Treatment:

Behavioral: Extensive FOCUS Program

Control

No Intervention group

Description:

Dyads randomized to CONTROL arm continued with standard clinical care.