NCT00106067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
559

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2009

Enrollment Period

4.4 years

First QC Date

March 18, 2005

Last Update Submit

April 6, 2015

Conditions

AgingNeoplasms

Keywords

agingbehavioral researchquality of lifeend of lifefamily relationssupportive careadvanced carebereavement

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • To assess the efficacy of the intervention among patients in coping and decisions around end of life.

    two years

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

NO INTERVENTION

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

Interventions

coping and communication support (CCS) interventionBEHAVIORAL

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 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Less than stage IV cancer, stage IV cancer diagnosed over 1 year previously or younger than 40 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Related 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. doi: 10.1097/01.NCC.0000343367.98623.83.

    PMID: 19104204RESULT

  • 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.

    PMID: 18488881RESULT

  • 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.

    PMID: 18840801RESULT

MeSH Terms

Conditions

NeoplasmsDeath

Interventions

Coping SkillsMethods

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesInvestigative Techniques

Study Officials

  • Julia Rose, PhD MA

    Louis Stokes VA Medical Center, Cleveland, OH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2005

First Posted

March 21, 2005

Study Start

June 1, 2004

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

April 7, 2015

Record last verified: 2009-04

Locations

US(1)