Comprehensive Assessment of Head and Neck Cancer Survivors

NCT01222481 | Completed

• 1 other identifier: 09-0433
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Cancer survivorship has dramatically improved within the last four decades and a greater number of Americans are living after cancer diagnosis. An increase in the number of survivors has highlighted the need to investigate the quality of life experienced by these survivors. While Survivorship research has improved our understanding of the challenges faced by some cancer survivors, there is a paucity of research on the functional and cognitive health status of head and neck cancer survivors. The purpose of this study is to evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to increase our understanding of the complex interactions between cancer treatment, comorbid health ailments and quality of life.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Functional Status; Cognitive Status; Neurocognitive Assessments; Performance-based Assessments; Cancer; Function; Cognition; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Functional and Cognitive health status

  At the time of cancer diagnosis and Within 1 month of cancer therapy

Secondary Outcomes (1)

• Assess the effectiveness of novel performance-based tests in detecting subtle functional and cognitive health status changes

  At the time of cancer diagnosis and Within 1 month of cancer therapy

Study Arms (1)

Newly-diagnosed Head and Neck Cancer

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Washington University Physicians Faculty Practice clinics of Adult Otolaryngology, Medical Oncology and Radiation Oncology

You may qualify if:

• Subjects must be 40 years of age or older.
• Subjects must be able to read, write and speak English fluently.
• Subjects must be newly diagnosed with head and neck squamous cell cancer.
• Subjects must not have already had treatment for this cancer diagnosis.
• Subjects must be anticipated to receive at least one of the following types of therapy: surgery, chemotherapy or radiation.

You may not qualify if:

• Subjects with prior cancer diagnoses who have evidence of active disease.
• Subjects who have received cancer treatment within the past year.
• Subjects who have received chemotherapy or radiation treatment within the past year (for any disease state).
• Life expectancy of less than 3 months.
• Subjects with melanoma or other non-squamous cell cancer.
• Subjects who score \>9 on Short Blessed Test (SBT) at baseline.
• Subjects who are unable to complete all of the required forms and tasks at baseline, either because of cognitive deficits or physical limitations.
• Any medical condition the PI determines to affect safe study participation.

Sponsors & Collaborators

• Jay F. Piccirillo, MD: lead
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

• Oluwafunmilola T Okuyemi, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jay F Piccirillo, MD, FACS

  Washington University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Washington University School of Medicine

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: July 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 2, 2012

Record last verified: 2012-02

Locations

US (2)