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

NCT00255697 | Completed DMC

• 2 other identifiers: CASE8Z05P30CA043703
• Study Type: observational
• Target: 863
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• 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 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

  at 3 months and 1 year

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Interventions

Psychiatric Rehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Barbara Daly, PhD, RN

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 21, 2005
• Study Start: July 1, 2005
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

US (1)