An observational study in Psychosocial Effects of Cancer and Its Treatment and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-09.
Sponsored by Case Comprehensive Cancer Center · Observational
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.
OBJECTIVES:
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
Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Primary care clinic
DISEASE CHARACTERISTICS:
Patient:
Caregiver:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Not specified
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.
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.
Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year
Time frame: at baseline, 3 months, and 1 year
Co-morbidities by Charlson at baseline
Time frame: 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
Quality of Life (QOL) by SF-12 at baseline
Time frame: 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
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
Social Support by Shortened Social Support Scale at baseline, 3 months, and 1 year
Time frame: 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
Mood state by Profile of Mood States at baseline, 3 months, and 1 year
Time frame: at baseline, 3 months, and 1 year
Optimism by Life Orientation Test at baseline
Time frame: at baseline
Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year
Time frame: at baseline, 3 months, and 1 year
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
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Case Comprehensive Cancer Center