Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients

Aging Clinical Trial

— A&SC  

Official title:

Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106067
• Other study ID #: IIR 03-255
• Status: Completed
• Phase: N/A
• First received: March 18, 2005
• Last updated: April 6, 2015
• Start date: June 2004
• Est. completion date: November 2008

Study information

• Verified date: April 2009
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Aging
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bowman KF, Rose JH, Radziewicz RM, O'Toole EE, Berila RA. Family caregiver engagement in a coping and communication support intervention tailored to advanced cancer patients and families. Cancer Nurs. 2009 Jan-Feb;32(1):73-81. — View Citation

Rose JH, O'Toole EE, Einstadter D, Love TE, Shenko CA, Dawson NV. Patient age, well-being, perspectives, and care practices in the early treatment phase for late-stage cancer. J Gerontol A Biol Sci Med Sci. 2008 Sep;63(9):960-8. — View Citation

Rose JH, Radziewicz R, Bowmans KF, O'Toole EE. A coping and communication support intervention tailored to older patients diagnosed with late-stage cancer. Clin Interv Aging. 2008;3(1):77-95. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		one year	No
Secondary	To assess the efficacy of the intervention among patients in coping and decisions around end of life.		two years	No