Cancer--Coping with Cancer |
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Clinical Trial: Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients
This study is currently recruiting patients.
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Purpose
The diagnosis of advanced, incurable cancer at different stages of the adult life span holds different meaning 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 caregiving from cancer treatment, through end-of-life care and, depending on their own coping resources and well-being. This proposal takes advantage of a time-limited opportunity to expand a National Cancer Institute (NCI R01)-funded coping and communication support (CCS) intervention study that is targeted for middle-aged and older advanced cancer patients by adding the assessment of family caregiver. Although caregiver outcomes are critically important, due to funding constraints, the NCI-funded study proposed to assess the effects of the CCS intervention only in patients. This VA HSR&D proposal is a request for additional funding to examine processes and outcomes of the intervention for family caregivers. We propose to test 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. This randomized controlled trial (RCT) will be 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.
This combined study will test effects of the CCS intervention for newly diagnosed stage IV cancer patients and their family caregivers over the period of time when goals of care are expected to shift. 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 primary goal of this project is to examine main effects 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. Hypotheses include main effects and patient age group interaction effects of the CCS intervention on care perspectives and well-being for family caregivers of middle-aged patients (40-60; N=139 caregivers in the intervention and 139 in the control group) and for family caregivers of young-old patients (61-80; N=139 caregivers in the intervention and 139 in the control group) during advanced cancer and in bereavement.
| Condition | Treatment or Intervention |
|---|---|
| Cancer | Behavior: Coping and communication support (CCS) intervention |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 556
Study start: June 2004; Expected completion: November 2008
Primary analyses include tests for overall (main) effects of the CCS intervention on family caregivers during advanced cancer care and in bereavement as well as patient age group by intervention interactions. We will be able to merge data collected in the associated NCI project on patients with this new information on family caregivers to incorporate patient-related variables in explaining variation in family caregiver outcomes. Congruence between caregivers and patients on satisfaction and communication during advanced cancer care will also be analyzed. Exploratory analyses will be conducted to examine (1) patient age group differences in preference for involvement of family caregivers, (2) patient age group differences in family caregiver engagement/contact with the CCS intervention and (3) differences in outcomes for family caregivers of veterans versus non-veterans.
Eligibility
Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
- Middle or older aged patients with advanced stages of cancer and their caregivers
Location and Contact Information
Ohio
VA Medical Center, Cleveland, Cleveland, Ohio, 44106-3800, United States; Recruiting
More Information
Publications
Rose JH, O'Toole EE, Dawson NV, Thomas C, Connors AF Jr, Wenger N, Phillips RS, Hamel MB, Reding DT, Cohen HJ, Lynn J. Generalists and oncologists show similar care practices and outcomes for hospitalized late-stage cancer patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks for Treatment. Med Care. 2000 Nov;38(11):1103-18.
Rose JH, Bowman KF, Kresevic D. Nurse versus family caregiver perspectives on hospitalized older patients: an exploratory study of agreement at admission and discharge. Health Commun. 2000;12(1):63-80.
Rose JH, O'Toole EE, Dawson NV, Lawrence R, Gurley D, Thomas C, Hamel MB, Cohen HJ. Perspectives, preferences, care practices, and outcomes among older and middle-aged patients with late-stage cancer. J Clin Oncol. 2004 Dec 15;22(24):4907-17. Epub 2004 Nov 1.
Hershkovitz A, Rothschild BM, Rose JH, Hornick T, O'Toole EE. Medical care perceptions in elderly patients with musculoskeletal complaints. Isr Med Assoc J. 2001 Nov;3(11):822-7.
D'eramo AL, Papp KK, Rose JH. A program on complementary therapies for long-term care nursing assistants. Geriatr Nurs. 2001 Jul-Aug;22(4):201-7.
Record last reviewed: March 2005
Last Updated: March 18, 2005
Record first received: March 18, 2005
ClinicalTrials.gov Identifier: NCT00106067
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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