Outcomes of Triaged Family Care in Advanced Cancer
FOCUS-Triage
3 other identifiers
interventional
484
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2005
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFebruary 11, 2014
October 1, 2013
4.9 years
July 1, 2008
February 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Quality of Life
Baseline, 3 and 6 months
Secondary Outcomes (13)
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
- +8 more secondary outcomes
Study Arms (3)
Brief
EXPERIMENTALDyads 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.
Extensive
EXPERIMENTALDyads 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.
Control
NO INTERVENTIONDyads randomized to CONTROL arm continued with standard clinical care.
Interventions
Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.
Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Wayne State Universitycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (5)
St. Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Center
Detroit, Michigan, 48202, United States
Wayne State University
Detroit, Michigan, 48202, United States
Providence Hospital Cancer Institute
Southfield, Michigan, 48075, United States
Related Publications (3)
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.
PMID: 15990903BACKGROUNDNorthouse 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.
PMID: 22290823RESULTGuan T, Chapman MV, de Saxe Zerden L, Zimmer C, Braden CJ, Rizo CF, Northouse L, Song L. Illness uncertainty and quality of life in patients with advanced cancer and their family caregivers: An actor-partner interdependence model analysis. Psychooncology. 2023 Nov;32(11):1744-1751. doi: 10.1002/pon.6228. Epub 2023 Oct 4.
PMID: 37794604DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurel L Northouse, PhD, RN
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 3, 2008
Study Start
June 1, 2005
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
February 11, 2014
Record last verified: 2013-10