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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Brief FOCUS Program; Behavioral: Extensive FOCUS Program

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.

• Study Type: Interventional
• Enrollment (Actual): 484
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48106
      • St. Joseph Mercy Cancer Center
    • Detroit, Michigan, United States, 48202
      • Wayne State University
    • Detroit, Michigan, United States, 48202
      • Karmanos Cancer Center
    • Southfield, Michigan, United States, 48075
      • Providence Hospital Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief; 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.	Behavioral: Brief FOCUS Program; Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.; Other Names: Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S); Family-based Intervention; Cancer Patient and Family Member Intervention
Experimental: Extensive; 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.	Behavioral: Extensive FOCUS Program; Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.; Other Names: Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S); Family-based Intervention; Cancer Patient and Family Member Intervention
No Intervention: Control; Dyads randomized to CONTROL arm continued with standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Quality of Life	Baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Uncertainty	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 Depression	Baseline, 3 and 6 months
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Cancer Institute (NCI); Wayne State University
• Investigators: Principal Investigator: Laurel L Northouse, PhD, RN, University of Michigan

Publications and helpful links

General Publications

• Northouse L. Helping families of patients with cancer. Oncol Nurs Forum. 2005 Jul 1;32(4):743-50. doi: 10.1188/05.onf.743-750.
• Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, LoRusso P, Hayes DF, Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Psychooncology. 2013 Mar;22(3):555-63. doi: 10.1002/pon.3036. Epub 2012 Jan 31.

Helpful Links

• University of Michigan Comprehensive Cancer Center website

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: July 1, 2008
• First Submitted That Met QC Criteria: July 2, 2008
• First Posted (Estimate): July 3, 2008

Study Record Updates

• Last Update Posted (Estimate): February 11, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Family caregiver; Breast Cancer; Lung Cancer; Quality of Life; communication; depression; Prostate Cancer; coping; Colorectal Cancer; Caregivers; Advanced Cancer; self-efficacy; Randomized Clinical Trial; uncertainty; cancer survivorship; support; benefits of illness
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: R01CA107383 (U.S. NIH Grant/Contract); UMCC 2003-094 (Other Identifier: University of Michigan); IRBMED No. 2004-0129 (Other Identifier: University of Michigan)