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

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year |  | at baseline, 3 months, and 1 year | 
| Co-morbidities by Charlson at baseline |  | at baseline | 
| Cognitive status by Short Orientation Concentration Memory Test at baseline, 3 months, and 1 year |  | at baseline, 3 months, and 1 year | 
| Quality of Life (QOL) by SF-12 at baseline |  | at baseline | 
| QOL and Symptoms by Functional Assessment of Cancer Therapy-General (FACT-G) at baseline, 3 months, and 1 year |  | at baseline, 3 months, and 1 year | 
| Spirituality by Functional Assessment of Chronic Illness Therapy (FACIT)-Sp at baseline, 3 months, and 1 year |  | at baseline, 3 months, and 1 year | 
| Social Support by Shortened Social Support Scale at baseline, 3 months, and 1 year |  | at baseline, 3 months, and 1 year | 
| Satisfaction with care by FACIT-TS-PS at 3 months and 1 year |  | at 3 months and 1 year | 
| Mood state by Profile of Mood States at baseline, 3 months, and 1 year |  | at baseline, 3 months, and 1 year | 
| Optimism by Life Orientation Test at baseline |  | at baseline | 
| Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year |  | at baseline, 3 months, and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at 3 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific