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

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
Kim Dittus, University of Vermont
ClinicalTrials.gov Identifier:
NCT01006902
First received: November 2, 2009
Last updated: November 28, 2011
Last verified: November 2011

November 2, 2009
November 28, 2011
November 2009
Not Provided
  • Determine change from baseline of physical function in elderly cancer patients after oncologic therapy. [ Time Frame: Baseline, post therapy, 3 months post therapy ] [ Designated as safety issue: No ]
  • Identify the relationship between cancer-related symptoms and physical function during oncologic therapy [ Time Frame: at end of therapy ] [ Designated as safety issue: No ]
Function as measured by strength, 6min walk test, PFP-10 and SPPB [ Time Frame: Baseline, post therapy, 3 months post therapy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01006902 on ClinicalTrials.gov Archive Site
  • Measure changes in quality of life during and after oncologic therapy [ Time Frame: Baseline, post therapy, 3 months post therapy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Cancer-related symptoms, cognition and quality of life [ Time Frame: Baseline, post therapy, 3 months post therapy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change
Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum samples will be obtained and stored at -80 degrees celsius

Non-Probability Sample

Individuals age 65 or older diagnosed with a malignancy and receiving chemotherapy or androgen deprivation therapy as part of their oncology therapy.

Cancer
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
May 2011
Not Provided

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.
Both
65 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01006902
Oncology therapy in elderly
Yes
Kim Dittus, University of Vermont
University of Vermont
Not Provided
Principal Investigator: Dittus Kim, MD University of Vermont
University of Vermont
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP