Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change
| Tracking Information | |||||
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| First Received Date ICMJE | November 2, 2009 | ||||
| Last Updated Date | November 28, 2011 | ||||
| Start Date ICMJE | November 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT01006902 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Cancer-related symptoms, cognition and quality of life [ Time Frame: Baseline, post therapy, 3 months post therapy ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change | ||||
| Official Title ICMJE | Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum samples will be obtained and stored at -80 degrees celsius |
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| 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. |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 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. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 3 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01006902 | ||||
| Other Study ID Numbers ICMJE | Oncology therapy in elderly | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kim Dittus, University of Vermont | ||||
| Study Sponsor ICMJE | University of Vermont | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Vermont | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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