Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity

October 15, 2014 updated by: Memorial Sloan Kettering Cancer Center

Prospective Evaluation of Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of study
Assess patterns of tobacco and/or alcohol use in cancer of the oral cavity survivors.
Time Frame: conclusion of the study
conclusion of the study
Assess the impact of lifestyle and socio-economic issues on post-therapy quality of life.
Time Frame: conclusion of the study
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Monash University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 28, 2007

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 04-137

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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