Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients (A&SC)

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Aging; Neoplasms

Treatments: Behavioral: coping and communication support (CCS) intervention

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT00106067

IIR 03-255

Details and patient eligibility

About

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.

Full 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.

Enrollment: 559 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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559 participants in 2 patient groups

Arm 1

Experimental group

Description:

In the intervention arm, Patients and their family caregivers have access to a coping and communication support practitioner (CCSP) (see intervention description) in addition to receiving the usual care in the site.

Treatment:

Behavioral: coping and communication support (CCS) intervention

Arm 2

No Intervention group

Description:

In the control arm, Patients are receiving the usual care in the site.