Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006902
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : November 3, 2009
Last Update Posted : November 29, 2011
Information provided by (Responsible Party):
Kim Dittus, University of Vermont

Brief Summary:
The proposed project will document the degree of function decline, assess the relationship between function and cancer- related symptoms and evaluate relationships between function and quality of life. Participants are evaluated before therapy, after therapy and again 3 months post therapy to evaluate functional change. Knowledge gained will help us plan interventions around the time of cancer therapy to help older adults preserve or improve function.

Condition or disease

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change
Study Start Date : November 2009
Actual Study Completion Date : May 2011

Individuals age 65 or older
Individuals age 65 or older receiving chemotherapy for cancer or short term androgen deprivation therapy for individuals 65 or older with prostate cancer.

Primary Outcome Measures :
  1. Determine change from baseline of physical function in elderly cancer patients after oncologic therapy. [ Time Frame: Baseline, post therapy, 3 months post therapy ]
  2. Identify the relationship between cancer-related symptoms and physical function during oncologic therapy [ Time Frame: at end of therapy ]

Secondary Outcome Measures :
  1. Measure changes in quality of life during and after oncologic therapy [ Time Frame: Baseline, post therapy, 3 months post therapy ]
  2. Evaluate the relationship between functional status and quality of life in elderly cancer patients receiving oncologic therapy [ Time Frame: Baseline, post therapy, 3 months post therapy ]

Biospecimen Retention:   Samples Without DNA
Serum samples will be obtained and stored at -80 degrees celsius

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals age 65 or older diagnosed with a malignancy and receiving chemotherapy or androgen deprivation therapy as part of their oncology therapy.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006902

United States, Vermont
University of Vermont/Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Principal Investigator: Dittus Kim, MD University of Vermont

Responsible Party: Kim Dittus, MD, PhD, Assistant Professor, University of Vermont Identifier: NCT01006902     History of Changes
Other Study ID Numbers: Oncology therapy in elderly
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: November 29, 2011
Last Verified: November 2011

Keywords provided by Kim Dittus, University of Vermont:
Oncologic therapy
Functional change with chemotherapy