Outcomes of Triaged Family Care in Advanced Cancer

Advanced Cancer Clinical Trial

— FOCUS-Triage  

Official title:

Outcomes of Triaged Family Care in Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709176
• Other study ID #: R01CA107383
• Secondary ID: R01CA107383UMCC
• Status: Completed
• Phase: N/A
• First received: July 1, 2008
• Last updated: February 10, 2014
• Start date: June 2005
• Est. completion date: May 2010

Study information

• Verified date: October 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	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	Providence Hospital Cancer Institute	Southfield	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Northouse L. Helping families of patients with cancer. Oncol Nurs Forum. 2005 Jul 1;32(4):743-50. — View Citation

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 patient — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life		Baseline, 3 and 6 months	No
Secondary	Risk for Distress		Baseline	No
Secondary	Change in Emotional Distress		Baseline, 3 and 6 months	No
Secondary	Change in Appraisal of Illness/Caregiving		Baseline, 3 and 6 months	No
Secondary	Change in Uncertainty		Baseline, 3 and 6 months	No
Secondary	Change in Hopelessness		Baseline, 3 and 6 months	No
Secondary	Change in Self-efficacy		Baseline, 3 and 6 months	No
Secondary	Change in Benefits of Illness		Baseline, 3 and 6 months	No
Secondary	Change in Family Communication		Baseline, 3 and 6 months	No
Secondary	Change in Support		Baseline, 3 and 6 months	No
Secondary	Change in Depression		Baseline, 3 and 6 months	No
Secondary	Change in Coping		Baseline, 3 and 6 months	No
Secondary	Change in Health Care Resource Utilization		Baseline, 3 and 6 months	No
Secondary	Change in Caregiver Burden		Baseline, 3 and 6 months	No

External Links

•   Principal Investigator's Faculty website
•   University of Michigan Comprehensive Cancer Center website