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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00582413
• Date of registration: 21/12/2007
• Primary sponsor: Memorial Sloan-Kettering Cancer Center
• Public title: Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity
• Scientific title: Prospective Evaluation of Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity
• Date of first enrolment: December 2004
• Target sample size: 164
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00582413
• Study type: Observational
• Study design: Observational Model: Case-Crossover, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Snehal Patel, MD
• Affiliation: Memorial Sloan-Kettering Cancer Center

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer of the Oral Cavity

Intervention(s)

Behavioral: questionnaires

Primary Outcome(s)

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]

Secondary Outcome(s)

Assess patterns of tobacco and/or alcohol use in cancer of the oral cavity survivors. [Time Frame: 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]

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]

Secondary ID(s)

04-137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Monash University