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Outcomes of Triaged Family Care in Advanced Cancer

18 Years
Not Enrolling
Advanced Cancer

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Trial Information

Outcomes of Triaged Family Care in Advanced Cancer

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Change in Quality of Life

Outcome Time Frame:

Baseline, 3 and 6 months

Safety Issue:


Principal Investigator

Laurel L Northouse, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

R01CA 107383



Start Date:

June 2005

Completion Date:

May 2010

Related Keywords:

  • Advanced Cancer
  • 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
  • Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Wayne State University Detroit, Michigan  48202
Karmanos Cancer Center Detroit, Michigan  48201
St. Joseph Mercy Cancer Center Ann Arbor, Michigan  48106
Providence Hospital Cancer Institute Southfield, Michigan  48075