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Completed

NCT Number: NCT00255697

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychosocial assessment and care

Procedure

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.

quality-of-life assessment

Procedure

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.

Primary outcomes

  1. Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year

    Time frame: at baseline, 3 months, and 1 year

  2. Co-morbidities by Charlson at baseline

    Time frame: at baseline

  3. Cognitive status by Short Orientation Concentration Memory Test at baseline, 3 months, and 1 year

    Time frame: at baseline, 3 months, and 1 year

  4. Quality of Life (QOL) by SF-12 at baseline

    Time frame: at baseline

  5. 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

  6. 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

  7. Social Support by Shortened Social Support Scale at baseline, 3 months, and 1 year

    Time frame: at baseline, 3 months, and 1 year

  8. Satisfaction with care by FACIT-TS-PS at 3 months and 1 year

    Time frame: at 3 months and 1 year

  9. Mood state by Profile of Mood States at baseline, 3 months, and 1 year

    Time frame: at baseline, 3 months, and 1 year

  10. Optimism by Life Orientation Test at baseline

    Time frame: at baseline

  11. Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year

    Time frame: at baseline, 3 months, and 1 year

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Nov 21, 2005
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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