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

Tracking Information

First Received Date ^ICMJE

November 18, 2005

Last Updated Date

August 19, 2009

Start Date ^ICMJE

July 2005

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00255697 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00255697

Responsible Party

Study ID Numbers ^ICMJE

CDR0000448642, CASE-8Z05

Study Sponsor ^ICMJE

Case Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Barbara Daly, PhD, RN

Case Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP