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Quality of Life of Older Patients Who Are Undergoing Treatment for Cancer and of Their Family Caregivers
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
First Received: November 18, 2005   Last Updated: May 9, 2009   History of Changes
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00255697
  Purpose

RATIONALE: Studying quality-of-life in patients having cancer treatment and in their caregivers may help identify the intermediate- and long-term effects of treatment on patients with cancer and on their caregivers.

PURPOSE: This clinical trial is studying quality of life of older patients who are undergoing treatment for cancer and of their family caregivers.


Condition Intervention
Psychosocial Effects/Treatment
Quality of Life
Unspecified Adult Solid Tumor, Protocol Specific
 Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Observational
Official Title: Quality of Life Study Registry for Persons With Cancer and Family Caregivers

Resource links provided by NLM:

MedlinePlus related topics: Cancer Caregivers
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year
  • Co-morbidities by Charlson at baseline
  • Cognitive status by Short Orientation Concentration Memory Test at baseline, 3 months, and 1 year
  • Quality of Life (QOL) by SF-12 at baseline
  • QOL and Symptoms by Functional Assessment of Cancer Therapy-General (FACT-G) at baseline, 3 months, and 1 year
  • Spirituality by Functional Assessment of Chronic Illness Therapy (FACIT)-Sp at baseline, 3 months, and 1 year
  • Social Support by Shortened Social Support Scale at baseline, 3 months, and 1 year
  • Satisfaction with care by FACIT-TS-PS at 3 months and 1 year
  • Mood state by Profile of Mood States at baseline, 3 months, and 1 year
  • Optimism by Life Orientation Test at baseline
  • Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year

Secondary Outcome Measures:
  • Trends over time (mood state, satisfaction, symptoms, QOL, caregiver burden, and cognitive status) for patient and caregiver by the tools listed above at 3 months and 1 year

Study Start Date: July 2005
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Obtain quality of life and psychosocial data from older patients who are undergoing treatment for cancer and from their family caregivers.

OUTLINE: This is a pilot, cross-sectional study.

Patients undergo a 45-minute interview in person or by phone to provide demographic data and to complete quality of life questionnaires, including Functional Assessment of Cancer Therapy (FACT), Spiritual tool, Quality and Satisfaction with Treatment (QUEST), and Profile of Mood State (POMS), at baseline and at 3 and 12 months. Caregivers undergo a 20- to 30-minute interview in person or by phone to provide demographic data and complete quality of life questionnaires, including the Caregiver Reaction Assessment (CRA), Quest, and POMS, at baseline and at 3 and 12 months. Caregivers complete the Quality of Death and Dying (QODD) questionnaire 2-3 months after the patient's death.

PROJECTED ACCRUAL: Not specified

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Patient:

    • Confirmed diagnosis of any type of cancer
    • Undergoing cancer treatment at Ireland Cancer Center

  • Caregiver:

    • Identified family caregiver of a patient diagnosed with cancer
  • Patient and caregiver may participate regardless of whether the other person agrees to participate or not

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-3 (patient)

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Able to speak and comprehend English
  • Cognitively competent to be interviewed (patient)

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255697

Locations
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara Daly, PhD, RN Case Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000448642, CASE-8Z05
Study First Received: November 18, 2005
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00255697     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
quality of life
psychosocial effects/treatment
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Quality of Life

ClinicalTrials.gov processed this record on July 06, 2009



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