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Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients


N/A
18 Years
N/A
Not Enrolling
Both
Aging, Neoplasms

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Trial Information

Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Julia Rose, PhD MA

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Medical Center, Cleveland

Authority:

United States: Federal Government

Study ID:

IIR 03-255

NCT ID:

NCT00106067

Start Date:

June 2004

Completion Date:

November 2008

Related Keywords:

  • Aging
  • Neoplasms
  • aging
  • behavioral research
  • quality of life
  • end of life
  • family relations
  • supportive care
  • advanced care
  • bereavement
  • Neoplasms

Name

Location

VA Medical Center, ClevelandCleveland, Ohio  44106-3800