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

October 8, 2015 updated by: Case Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

863

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year
Time Frame: at baseline, 3 months, and 1 year
at baseline, 3 months, and 1 year
Co-morbidities by Charlson at baseline
Time Frame: at baseline
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
at baseline, 3 months, and 1 year
Quality of Life (QOL) by SF-12 at baseline
Time Frame: at baseline
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
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
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
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
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
at baseline, 3 months, and 1 year
Optimism by Life Orientation Test at baseline
Time Frame: at baseline
at baseline
Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year
Time Frame: at baseline, 3 months, and 1 year
at baseline, 3 months, and 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: at 3 months and 1 year
at 3 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Barbara Daly, PhD, RN, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria

November 18, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CASE8Z05 (Other Identifier: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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