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

NCT01006902 | Terminated DMC

• 1 other identifier: Oncology therapy in elderly
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Elderly; Function; Oncologic therapy; Functional change with chemotherapy

Outcome Measures

Primary Outcomes (2)

• Determine change from baseline of physical function in elderly cancer patients after oncologic therapy.

  Baseline, post therapy, 3 months post therapy

• Identify the relationship between cancer-related symptoms and physical function during oncologic therapy

  at end of therapy

Secondary Outcomes (2)

• Measure changes in quality of life during and after oncologic therapy

  Baseline, post therapy, 3 months post therapy

• Evaluate the relationship between functional status and quality of life in elderly cancer patients receiving oncologic therapy

  Baseline, post therapy, 3 months post therapy

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont/Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Dittus Kim, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant Professor

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 3, 2009
• Study Start: November 1, 2009
• Study Completion: May 1, 2011
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

US (1)