Clinical trial NCT00709176: Outcomes of Triaged Family Care in Advanced Cancer
Official title: Outcomes of Triaged Family Care in Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: 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
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Wayne State University
name: National Cancer Institute (NCI)
First posted: 2008-07-03
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Risk for Distress
timeFrame: Baseline
measure: Change in Emotional Distress
timeFrame: Baseline, 3 and 6 months
measure: Change in Appraisal of Illness/Caregiving
timeFrame: Baseline, 3 and 6 months
measure: Change in Uncertainty
timeFrame: Baseline, 3 and 6 months
measure: Change in Hopelessness
timeFrame: Baseline, 3 and 6 months
measure: Change in Self-efficacy
timeFrame: Baseline, 3 and 6 months
measure: Change in Benefits of Illness
timeFrame: Baseline, 3 and 6 months
measure: Change in Family Communication
timeFrame: Baseline, 3 and 6 months
measure: Change in Support
timeFrame: Baseline, 3 and 6 months
measure: Change in Depression
timeFrame: Baseline, 3 and 6 months
measure: Change in Coping
timeFrame: Baseline, 3 and 6 months
measure: Change in Health Care Resource Utilization
timeFrame: Baseline, 3 and 6 months
measure: Change in Caregiver Burden
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Cancer Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital Cancer Institute
state: Michigan
Study officials:
affiliation: University of Michigan
name: Laurel L Northouse, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 patients and their family caregivers. Psychooncology. 2013 Mar;22(3):555-63. doi: 10.1002/pon.3036. Epub 2012 Jan 31.