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Clinical Trials/NCT00106067
NCT00106067
Completed
Not Applicable

Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients

US Department of Veterans Affairs1 site in 1 country559 target enrollmentJune 2004
ConditionsAgingNeoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
US Department of Veterans Affairs
Enrollment
559
Locations
1
Primary Endpoint
The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.

Detailed Description

We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center. Recruitment and randomization are based on patient's diagnosis and age. The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). Patients are stratified by age group and then randomized to usual care or CCS intervention. Family care-givers are randomized along with the patient. Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners. They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
November 2008
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed within 1 year with advanced cancer (stage IV), aged 40 years or older.
  • Patients must be cognitively intact at time of enrollment.
  • Patient need not have family care-giver to be enrolled, but if there is one, FCG is enrolled with the patient. FCG need not be 40 years of age.

Exclusion Criteria

  • Less than stage IV cancer, stage IV cancer diagnosed over 1 year previously or younger than 40 years of age.

Outcomes

Primary Outcomes

The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.

Time Frame: one year

Secondary Outcomes

  • To assess the efficacy of the intervention among patients in coping and decisions around end of life.(two years)

Study Sites (1)

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