Patient Preferences in Making Treatment Decisions in Patients With Stage I-IVA Oropharyngeal Cancer

The University of Chicago

Status: Terminated

Conditions: Stage II Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Tongue Cancer; Stage I Squamous Cell Carcinoma of the Oropharynx

Treatments: Other: questionnaire administration; Procedure: quality-of-life assessment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01949740

13-0552

P30CA014599 (U.S. NIH Grant/Contract)

IRB13-0552

NCI-2013-01181 (Registry Identifier)

Details and patient eligibility

About

This pilot research trial studies patient preferences in making treatment decisions in patients with stage I-IVA oropharyngeal cancer. Questionnaires that measure patient priorities before and after treatment may improve the ability to plan for better quality of life in patients with oropharyngeal cancer.

Full description

PRIMARY OBJECTIVES:

I. Determine the stability of Head and Neck Priorities Scale (HNPS) ranking between pre- and post-treatment assessments.

SECONDARY OBJECTIVES:

I. Use patient-interviews to refine and modify the HNPS for use in a larger scale trial.

II. Pilot the Head and Neck Patient Outcomes Survey (HNPOS) as a potential tool to identify priorities most important to quality-of-life outcomes.

III. Use the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) and EurolQoL-5D to determine the validity of the HNPOS.

OUTLINE:

Patients participate in a 45-minute interview comprising assessment of priorities and quality of life at baseline, 1, 6, and 12 months.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment naïve American Joint Committee on Cancer (AJCC) stage I-IVa squamous cell carcinoma of the head and neck with no definitive evidence of metastatic disease
• Sufficient vision, writing, and communication ability to complete the interviews and assessment tool
• Signed informed consent

Exclusion criteria

• Patients who are enrolled in other head and neck cancer treatment protocols are permitted to participate in this study if a) the other protocol permits this and b) the other protocol does not utilize the HNPS
• Patients who have previously undergone cancer treatment or are presently undergoing additional cancer treatments
• Patients who have already undergone unsuccessful curative-intent surgery on their head and neck cancer
• Patients, who have had a major surgery (defined as requiring general anesthesia but not including tonsillectomy, neck dissection, or panendoscopy [triple endoscopy or examination under general anesthesia]), or significant traumatic injury within 4 weeks of the study; patients who have not recovered from the side effects of any of the above surgeries
• Patients unwilling to or unable to comply with the protocol
• Patients unable to communicate with the interviewer

Trial design

37 participants in 1 patient group

Observational (patient preferences)

Description:

Patients participate in a 45-minute interview comprising assessment of priorities and quality of life at baseline, 1, 6, and 12 months.

Treatment:

Procedure: quality-of-life assessment

Other: questionnaire administration