Clinical trial NCT00255697: Quality of Life of Older Patients Who Are Undergoing Treatment for Cancer and of Their Family Caregivers
Official title: Quality of Life Study Registry for Persons With Cancer and Family Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-11-21
Enrollment: 863
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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

Eligibility 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

Primary outcomes:
measure: Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year
timeFrame: at baseline, 3 months, and 1 year
measure: Co-morbidities by Charlson at baseline
timeFrame: at baseline
measure: Cognitive status by Short Orientation Concentration Memory Test at baseline, 3 months, and 1 year
timeFrame: at baseline, 3 months, and 1 year
measure: Quality of Life (QOL) by SF-12 at baseline
timeFrame: at baseline
measure: QOL and Symptoms by Functional Assessment of Cancer Therapy-General (FACT-G) at baseline, 3 months, and 1 year
timeFrame: at baseline, 3 months, and 1 year
measure: Spirituality by Functional Assessment of Chronic Illness Therapy (FACIT)-Sp at baseline, 3 months, and 1 year
timeFrame: at baseline, 3 months, and 1 year
measure: Social Support by Shortened Social Support Scale at baseline, 3 months, and 1 year
timeFrame: at baseline, 3 months, and 1 year
measure: Satisfaction with care by FACIT-TS-PS at 3 months and 1 year
timeFrame: at 3 months and 1 year
measure: Mood state by Profile of Mood States at baseline, 3 months, and 1 year
timeFrame: at baseline, 3 months, and 1 year
measure: Optimism by Life Orientation Test at baseline
timeFrame: at baseline
measure: Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year
timeFrame: at baseline, 3 months, and 1 year
Secondary outcomes:
measure: 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
timeFrame: at 3 months and 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Barbara Daly, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: