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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00255697
First received: November 18, 2005
Last updated: December 3, 2012
Last verified: December 2012
  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:


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 ]

Enrollment: 863
Study Start Date: July 2005
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: psychosocial assessment and care
    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.
    Procedure: quality-of-life assessment
    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
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Barbara Daly, PhD, RN Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
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: December 3, 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 April 17, 2014