Clinical trial NCT00873600: Outpatient Health Care Program for Older Patients Receiving Chemotherapy for Newly Diagnosed Breast Cancer or Colon Cancer
Official title: A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Cognitive/Functional Effects
Colorectal Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: cognitive/functional effects
psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
adenocarcinoma of the colon
stage I colon cancer
stage II colon cancer
stage III colon cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: RATIONALE: Gathering health information from older patients undergoing chemotherapy may help doctors plan better treatment and improve the quality of life for these patients.

PURPOSE: This randomized clinical trial is studying how well an outpatient health care program works for older patients receiving chemotherapy for newly diagnosed breast cancer or colon cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the effect of a 1-year geriatric evaluation and management (GEM) program on adherence to adjuvant chemotherapy (defined as tolerance and timely completion of planned dose) in patients with newly diagnosed breast or colon cancer.

Secondary

* Evaluate the effect of a 1-year GEM program on the health-related quality of life and functional, cognitive, and mental status of these patients.
* Evaluate the effect of a 1-year GEM program on 3-year disease-free survival of these patients.
* Compare the number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization to a GEM program vs no program.

OUTLINE: Patients are stratified according to tumor site (breast vs colon). Patients are randomized to 1 of 2 arms.

* Arm I (intervention): Patients complete health-related quality-of-life (QOL) and comprehensive geriatric assessment questionnaires at baseline, within 30 days after chemotherapy or at 6 months, and then at 12-13 months to assess functional status (i.e., activities of daily living), comorbidity (i.e., medical problems), medications, mood and memory, nutrition, and social support from family members and friends. Patients receive a home visit from a social worker and visit the Senior Adult Oncology clinic within 1 month after the first course of chemotherapy. The clinic staff develops an individualized care plan for the patient and communicates the results of the assessment questionnaires and their recommendations (e.g., medication and/or specialty referrals) to the patient's primary care provider and oncologist. The staff meets weekly to monitor and update the patient care plan. Patients are followed in the Senior Adult Oncology clinic at least every 3 months for 1 year. Follow-up telephone calls and in-home visits are also conducted as needed. Patients are also assessed prior to each course of chemotherapy for toxicities related to the chemotherapy.
* Arm II (control): Patients complete a health-related QOL questionnaire at baseline, within 30 days after chemotherapy or at 6 months, and then at 12-13 months. Patients receive oncology and primary care by their usual health care providers.

After completion of the study intervention, patients' medical charts are reviewed periodically for up to 2 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma, including one of the following:

  * Breast cancer (female), meeting the following criteria:

    * Stage I-III (T1-4, N0-3, M0) disease
    * Has undergone complete surgical removal of invasive cancer by mastectomy or lumpectomy
    * Has undergone either sentinel lymph node dissection or axillary lymph node dissection with adequate TNM staging
  * Colon cancer (male or female), meeting the following criteria:

    * Stage I-III (T1-3, any N, M0) disease
    * Has undergone appropriate surgical resection with TNM staging
* Newly diagnosed disease
* Scheduled to receive chemotherapy

  * Agrees to receive chemotherapy AND is able to receive chemotherapy within 3 months after surgery
* No distant metastases
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Life expectancy ≥ 6 months
* Fluent in English
* Not living in a nursing home
* No end-stage disease
* No severe dementia
* No other clinically active malignancy within the past 5 years or within 3 months after diagnosis of current malignancy

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy for the malignancy
* More than 1 year since prior treatment on an inpatient/outpatient geriatric evaluation and management unit

Primary outcomes:
measure: Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities
Secondary outcomes:
measure: Mean change in comprehensive geriatric assessment scores and quality-of-life scores from baseline to post-chemotherapy and from baseline to 12 months following randomization
measure: Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization
measure: 3-year disease-free survival
Other outcomes:
Locations:
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Cynthia Owusu, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References: