Finding Predictors of Side Effects to Chemoradiation Treatment in Elderly Patients With Head and Neck Cancer

NCT01688323 | Completed DMC

• 2 other identifiers: LCCC120812-0805
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

To look at what types of measures can be used to predict how an older person will tolerate chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw to look at the different measures.

Conditions

Head and Neck Cancer

Keywords

Geriatrics; Oncology; Biological Markers; Survey Instruments; p16; Geriatric Oncology; Biological Markers of Aging; Symptom Assessment; Cancer; Older Persons; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Significant Change in Function from Baseline to Post-Treatment

  To determine if there is a significant change in the Instrumental Activities of Daily Living (IADL) subscore of the Geriatric Assessment (GA) from baseline to 90 days post-treatment.

  2 years

Secondary Outcomes (5)

• Explore Association between Baseline Measures and Decline in Living Status

  2 years

• Explore Association of Baseline Measures with Grade 3 or Higher Toxicity

  2 years

• Explore Association of Baseline p16 with Baseline GA Measures

  2 years

• Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.

  2 years

• Explore Association between Baseline Measures and Changes in IADL Subscore

  2 years

Study Arms (1)

Elderly Chemorads

Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy

Other: Collect Blood and Survey Instruments

Interventions

Collect Blood and Survey Instruments OTHER

Each subject will be administered the appropriate surveys and blood draws over the course of the study.

Also known as: Geriatric Assessment, FACT-HN, p16 Expression, Health Behavior Questionnaire

Elderly Chemorads

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly (65 and older) patients with Head and Neck Cancer

You may qualify if:

• Signed, IRB approved written informed consent.
• Age of at least 65 years.

You may not qualify if:

• Inability to read and speak English.
• Inability to comply with study for any other reason than language

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• UNC Geriatric Oncology Program

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Interventions

Surveys and Questionnaires; Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Status; Demography; Population Characteristics; Epidemiologic Measurements

Study Officials

• Jared Weiss, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 19, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: May 1, 2016
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

US (1)