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

Sponsor:	Case Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Case Comprehensive Cancer Center
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 of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific	Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
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 Case Comprehensive Cancer Center:

Primary Outcome Measures:

Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year [ Time Frame: at baseline, 3 months, and 1 year ] [ Designated as safety issue: No ]
Co-morbidities by Charlson at baseline [ Time Frame: at baseline ] [ Designated as safety issue: No ]
Cognitive status by Short Orientation Concentration Memory Test at baseline, 3 months, and 1 year [ Time Frame: at baseline, 3 months, and 1 year ] [ Designated as safety issue: No ]
Quality of Life (QOL) by SF-12 at baseline [ Time Frame: at baseline ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Social Support by Shortened Social Support Scale at baseline, 3 months, and 1 year [ Time Frame: at baseline, 3 months, and 1 year ] [ Designated as safety issue: No ]
Satisfaction with care by FACIT-TS-PS at 3 months and 1 year [ Time Frame: at 3 months and 1 year ] [ Designated as safety issue: No ]
Mood state by Profile of Mood States at baseline, 3 months, and 1 year [ Time Frame: at baseline, 3 months, and 1 year ] [ Designated as safety issue: No ]
Optimism by Life Orientation Test at baseline [ Time Frame: at baseline ] [ Designated as safety issue: No ]
Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year [ Time Frame: at baseline, 3 months, and 1 year ] [ Designated as safety issue: No ]

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 [ Time Frame: at 3 months and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	July 2005
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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
Sampling Method:	Probability Sample

Study Population

Primary care clinic

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 Medical Center, University Hospitals Seidman Cancer Center, 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 Medical Center, University Hospitals Seidman Cancer Center, 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

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00255697 History of Changes
Other Study ID Numbers:	CASE8Z05, P30CA043703, CASE8Z05
Study First Received:	November 18, 2005
Last Updated:	February 1, 2012
Health Authority:	United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:

psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on February 13, 2012