Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00740961
First received: August 22, 2008
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

RATIONALE: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.


Condition Intervention
Breast Cancer
Cognitive/Functional Effects
Colorectal Cancer
Psychosocial Effects of Cancer and Its Treatment
Behavioral: compliance monitoring
Drug: systemic chemotherapy
Other: medical chart review
Other: study of socioeconomic and demographic variables
Other: survey administration
Procedure: cognitive assessment
Procedure: psychosocial assessment and care

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Vulnerable Elders Survey Study of Older Cancer Patients

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of impaired domains on Comprehensive Geriatric Assessment (CGA) [ Time Frame: at baseline and 12 months later. ] [ Designated as safety issue: No ]
  • Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities [ Time Frame: Patients are followed for 1 year for chemotherapy adherence and survival. ] [ Designated as safety issue: No ]
  • Vulnerable Elders Survey scores [ Time Frame: at baseline and 12 months later. ] [ Designated as safety issue: No ]
  • Functional decline [ Time Frame: at baseline and 12 months later. ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: Patients are followed for 1 year for chemotherapy adherence and survival. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores of individual battery of tools included in the CGA [ Time Frame: at baseline and 12 months later ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Approximately 13mls of blood will be drawn at each of the three time-points for testing for biologic correlates of frailty (pre study, mid-study and post-study).


Enrollment: 63
Study Start Date: March 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
Behavioral: compliance monitoring
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Drug: systemic chemotherapy
Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer
Other: medical chart review
A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
Other: study of socioeconomic and demographic variables
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Other: survey administration
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Procedure: cognitive assessment
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Procedure: psychosocial assessment and care
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Patients without cancer
non-cancer patients, seeking care at out-patient clinics
Behavioral: compliance monitoring
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Other: medical chart review
A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
Other: study of socioeconomic and demographic variables
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Other: survey administration
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Procedure: cognitive assessment
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Procedure: psychosocial assessment and care
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.

Detailed Description:

OBJECTIVES:

  • Determine the correlation between the Vulnerable Elders Survey (VES-13) and the battery of Comprehensive Geriatric Assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting.
  • Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients.
  • Examine the validity of the VES-13 screening tool to identify increased risk of death from all causes at one year after initial VES-13 screening in these patients.
  • Examine the validity of the VES-13 screening tool to identify increased risk of functional decline at one year after initial VES-13 screening in these patients.

OUTLINE: Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.

Patients are followed for 1 year for chemotherapy adherence and survival.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care clinic

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast or colon cancer

    • Newly diagnosed disease
    • Any stage disease
  • Undergoing treatment at the Ireland Cancer Center, University Hospitals Case Medical Center Site
  • Scheduled to start a new chemotherapy regimen (objective II only)
  • Not concurrently enrolled in a GEM trial (objectives II, III, and IV)
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Understands English
  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • See Diseases Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740961

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
UH-LUICC
Mentor, Ohio, United States, 44060
UH-Chagrin Highlands
Orange Village, Ohio, United States, 44122
UH-Green Road
South Euclid, Ohio, United States, 44121
UH-Westlake
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Cynthia Owusu, MD, MSC Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00740961     History of Changes
Other Study ID Numbers: CASE8Y07, P30CA043703, CASE8Y07
Study First Received: August 22, 2008
Last Updated: September 20, 2011
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
psychosocial effects of cancer and its treatment
cognitive/functional effects
breast cancer
colon cancer

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 21, 2014