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Clinical Trials/NCT00255697
NCT00255697
Completed
N/A

Quality of Life Study Registry for Persons With Cancer and Family Caregivers

Case Comprehensive Cancer Center1 site in 1 country863 target enrollmentJuly 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosocial Effects of Cancer and Its Treatment
Sponsor
Case Comprehensive Cancer Center
Enrollment
863
Locations
1
Primary Endpoint
Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
July 2005
End Date
December 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year

Time Frame: at baseline, 3 months, and 1 year

Co-morbidities by Charlson at baseline

Time Frame: at baseline

Cognitive status by Short Orientation Concentration Memory Test at baseline, 3 months, and 1 year

Time Frame: at baseline, 3 months, and 1 year

Quality of Life (QOL) by SF-12 at baseline

Time Frame: at baseline

QOL and Symptoms by Functional Assessment of Cancer Therapy-General (FACT-G) at baseline, 3 months, and 1 year

Time Frame: at baseline, 3 months, and 1 year

Spirituality by Functional Assessment of Chronic Illness Therapy (FACIT)-Sp at baseline, 3 months, and 1 year

Time Frame: at baseline, 3 months, and 1 year

Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year

Time Frame: at baseline, 3 months, and 1 year

Social Support by Shortened Social Support Scale at baseline, 3 months, and 1 year

Time Frame: at baseline, 3 months, and 1 year

Satisfaction with care by FACIT-TS-PS at 3 months and 1 year

Time Frame: at 3 months and 1 year

Mood state by Profile of Mood States at baseline, 3 months, and 1 year

Time Frame: at baseline, 3 months, and 1 year

Optimism by Life Orientation Test at baseline

Time Frame: at baseline

Secondary Outcomes

  • 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(at 3 months and 1 year)

Study Sites (1)

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