Clinical trial NCT01949740: Patient Preferences in Making Treatment Decisions in Patients With Stage I-IVA Oropharyngeal Cancer
Official title: Patient Preferences in Head and Neck Cancer Treatment Decisions - a Pilot Study of the Durability of Patient Priorities
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stage I Squamous Cell Carcinoma of the Oropharynx
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
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-09-24
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be identified through the Hematology/Oncology and ENT clinics a at their first visit for newly diagnosed Head/ Neck Cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stability of HNPS ranking between pre- and post-treatment assessments
timeFrame: Up to 12 months
Secondary outcomes:
measure: Reliability of HNPPQ scale, in terms of test-retest and internal consistency
timeFrame: Up to 12 months
measure: Validity of HNPOS
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Alexander Langerman
role: PRINCIPAL_INVESTIGATOR
References: