Quality of Life of Older Patients Who Are Undergoing Treatment for Cancer and of Their Family Caregivers

Completed

• Conditions: Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00255697
• Lead Sponsor: Case Comprehensive Cancer Center

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

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-21
• Primary Completion: 2012-03
• Study Completion: 2012-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 863

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States