Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients

NCT ID: NCT00106067

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 559 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2008-11-30

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.

Conditions

Aging; Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

coping and communication support (CCS) intervention

Intervention Type: BEHAVIORAL

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.

Arm 2

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Rose, PhD MA

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Countries

United States

References

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. doi: 10.1097/01.NCC.0000343367.98623.83.

Reference Type: RESULT

PMID: 19104204 (View on PubMed)

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. doi: 10.2147/cia.s1262.

Reference Type: RESULT

PMID: 18488881 (View on PubMed)

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. doi: 10.1093/gerona/63.9.960.

Reference Type: RESULT

PMID: 18840801 (View on PubMed)

Other Identifiers

IIR 03-255

Identifier Type: -

Identifier Source: org_study_id