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

NCT00582413 | Completed

• 1 other identifier: 04-137
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of the Oral Cavity

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  conclusion of study

Secondary Outcomes (3)

• 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

  conclusion of study

• Assess patterns of tobacco and/or alcohol use in cancer of the oral cavity survivors.

  conclusion of the study

• Assess the impact of lifestyle and socio-economic issues on post-therapy quality of life.

  conclusion of the study

Study Arms (1)

1

Patients who have been diagnosed with Carcinoma of the oral cavity

Behavioral: questionnaires

Interventions

questionnaires BEHAVIORAL

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Monash University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

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

Study Officials

• Snehal Patel, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: December 1, 2004
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

US (1)