Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change
65 Years
90 Years
Both
Cancer
Trial Information
Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change
The study looks at functional change of elderly cancer patients. Approximately 52 cancer
patients age 65 or older will be asked to participate. Cancer patients asked to participate
will be receiving cancer therapy with the intention of providing a cure. Functional change
will be assessed from the time of diagnosis, through therapy to the early post therapy time
frame. A comprehensive model explaining reasons for function change is used as the
framework for choosing variables to measure. Components of function that will be measured
include a 6 minute walk test, lower extremity muscle strength, a Short Physical Performance
Battery assessing function of legs and a test that simulates typical household activities.
Surveys will be used to subjects own assessment of their activity and function. The four
most common cancer-related side effects will be measured and include fatigue, sleep
impairment, shortness of breath and pain. Some markers in the blood may be abnormal and be
related to declines in function. They will also be measured. Differences in function over
time will be determined and relationships between function, cancer-related side effects and
quality of life will be assessed.
Inclusion Criteria:
- Age 65 or older
- Diagnosis of a malignancy requiring chemotherapy as part of intent to cure oncologic
therapy or diagnosis of prostate cancer requiring 6 months or less of androgen
deprivation therapy as part of oncologic treatment.
- A planned oncologic regimen of at least 3 months but not more than 9 months excluding
surgery. This will include most solid tumors and lymphoma.
- Ability to understand and the willingness to sign a written informed consent
document.
Exclusion Criteria:
- Prior treatment for malignancy other than basal or squamous cell skin cancer
- Evidence of metastatic disease
- Individuals with acute and chronic leukemias and individuals receiving anti-estrogen
therapy only as their primary oncologic treatment.
- Dementia, psychotic condition or other central nervous system impairment limiting
compliance
- Medical conditions that limit ability to walk at least 4 meters.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Determine change from baseline of physical function in elderly cancer patients after oncologic therapy.
Outcome Time Frame:
Baseline, post therapy, 3 months post therapy
Safety Issue:
No
Principal Investigator
Dittus Kim, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Vermont
Authority:
United States: Institutional Review Board
Study ID:
Oncology therapy in elderly
NCT ID:
NCT01006902
Start Date:
November 2009
Completion Date:
May 2011
Related Keywords:
- Cancer
- Elderly
- Function
- Oncologic therapy
- Functional change with chemotherapy
Name | Location |
|---|---|
| University of Vermont/Fletcher Allen Health Care | Burlington, Vermont 05405 |
