Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00582413

Purpose

The purpose of this study is to learn more about the quality of life and emotional changes that patients experience during their treatment for cancer of the mouth. We want to learn more about the emotional and quality of life problems that occur during and after treatment. This will help us better understand these complex issues and improve treatment.

Condition	Intervention
Cancer of the Oral Cavity	Behavioral: questionnaires

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Crossover, Prospective
Official Title:	Prospective Evaluation of Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

is to assess quality of life and psychosocial adaptation in patients undergoing treatment for cancer of the oral cavity so that we can develop empirically-informed interventions to improve the adaptation of these patients. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Validate two new measures of psychosocial adjustment in patients treated for cancer of the oral cavity and upper aerodigestive SCC: The Shame and Stigma in Head and Neck Cancer Scale and the Demoralization Scale [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	133
Study Start Date:	December 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients who have been diagnosed with Carcinoma of the oral cavity	Behavioral: questionnaires Patient will fill out questionnaires, initial clinic visit, first post-surgery clinic evaluation and 3, 6, 12, 18 and 24 months following completion of all therapy.

Detailed Description:

The objectives of this project are to prospectively assess quality of life (QOL) and psychosocial adaptation in patients undergoing treatment for carcinoma of the oral cavity, including squamous cell carcinoma of the oral cavity (SCCOC) and to validate new instruments (shame & stigma, demoralization) that will guide quality of life assessment of patients with cancer of the oral cavity. We will utilize modifications of previously described and validated questionnaires that will be administered to eligible patients before the start of their therapy and at several predefined time points during the post-therapy period. This prospective longitudinal assessment will allow us to study the impact of patient demographic, tumor, treatment and lifestyle related variables on the quality of life of patients treated for oral cavity cancer.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients seen on the Head and Neck Surgery Service, Radiation Oncology Service, Medical Oncology Service and Dental Service.

Criteria

Inclusion Criteria:

PATIENT INCLUSION CRITERIA FOR THE LONDITUDINAL STUDY:

Carcinoma of the oral cavity including one or more of the following anatomic sub-sites: Anterior 2/3rds of the tongue, the floor of the mouth, the upper and lower gums, buccal mucosa, retromolar trigone, hard palate and minor salivary glands.
Surgically resectable disease in the oral cavity and the neck.
Patients with prior cancers other than Head and Neck cancers who are currently in remission, have no evidence of disease and are not undergoing any active chemotherapy or radiation therapy.

Exclusion Criteria:

EXCLUSION FOR THE LONDITUDINAL STUDY:

Primary tumor of the lips (these are skin cancers).
Surgical treatment excluding diagnostic biopsy of the primary site or biopsy of neck node/s prior to referral to MSKCC.
Surgically unresectable disease in the neck; including carotid encasement, massive dermal infiltration, and other clinical and radiographic findings which would preclude surgically resectable nodal disease in the neck, prior to initiation of treatment.
Evidence of distant metastases by clinical or radiographic examination.
Patients with more than one simultaneous primary tumor.
Patient unable to read or comprehend the content of the questionnaires due to language barriers or psychiatric disorders.

PATIENT INCLUSION CRITERIA FOR THE CROSS-SECTIONAL STUDY:

Upper aerodigestive squamous cell carcinoma, including the oropharynx, hypopharynx and larynx - newly diagnosed or recurrent cancers.
Newly diagnosed and recurrent carcinoma of the oral cavity including one or more of the following anatomic sub-sites: Anterior 2/3rds of the tongue, the floor of the mouth, the upper and lower gums, buccal mucosa, retromolar trigone, hard palate and minor salivary glands.

EXCLUSION CRITERIA FOR THE CROSS-SECTIONAL STUDY:

Primary tumor of the lips (these are skin cancers).
Patient unable to read or comprehend the content of the questionnaires due to language barriers or psychiatric disorders.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582413

Contacts

Contact: David Kissane, MD	646-888-0019	kissaned@mskcc.org
Contact: Bhuvanesh Singh, MD	212-639-2024	singhb@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: David Kissane, MD 646-888-0019 kissaned@mskcc.org
Contact: Bhuvanesh Singh, MD 212-639-2024 singhb@mskcc.org
Principal Investigator: David Kissane, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

David Kissane, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( David Kissane, MD )
Study ID Numbers:	04-137
Study First Received:	December 21, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00582413
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Head and Neck Cancer

Study placed in the following topic categories:

Head and Neck Neoplasms
Quality of Life

ClinicalTrials.gov processed this record on February 06, 2009