Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients (A&SC)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aging Neoplasms |
Behavioral: coping and communication support (CCS) intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients |
- 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 ] [ Designated as safety issue: No ]
- To assess the efficacy of the intervention among patients in coping and decisions around end of life. [ Time Frame: two years ] [ Designated as safety issue: No ]
| Enrollment: | 559 |
| Study Start Date: | June 2004 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
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.
|
Behavioral: coping and communication support (CCS) intervention
Trained clinical nurse specialists with masters� degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families. |
|
No Intervention: Arm 2
In the control arm, Patients are receiving the usual care in the site.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00106067 History of Changes |
| Other Study ID Numbers: | IIR 03-255 |
| Study First Received: | March 18, 2005 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
aging behavioral research quality of life end of life |
family relations supportive care advanced care bereavement |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013