Know Cancer

or
forgot password

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


N/A
N/A
N/A
Open (Enrolling)
Both
Cancer of the Oral Cavity

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Crossover, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Snehal Patel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-137

NCT ID:

NCT00582413

Start Date:

December 2004

Completion Date:

December 2013

Related Keywords:

  • Cancer of the Oral Cavity
  • Head and Neck Cancer

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021