Stage III Squamous Cell Carcinoma of the Oropharynx, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Tongue Cancer
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERquestionnaire administration
Ancillary studies
PROCEDUREquality-of-life assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Chicago
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stability of HNPS ranking between pre- and post-treatment assessments | Up to 12 months | Proportion of patients for whom the domain was considered stable calculated. Exact binomial tests will be used to test whether each proportion is greater than 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reliability of HNPPQ scale, in terms of test-retest and internal consistency | Up to 12 months | Weighted kappa coefficients will serve as the measure of agreement between the two replicates. Cronbach's alpha will be used to assess internal consistency. |
| Validity of HNPOS | Up to 12 months | Nine HNPOS items will be compared to corresponding items on the FACT H&N scale. For each item, Kendall's tau-c will be computed for a measure of association suitable for contingency analyses of two ordinal variables. |
Countries
United States
Outcome results
None listed