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

Terminated

• Conditions: Stage I Squamous Cell Carcinoma of the Oropharynx; Tongue Cancer; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage II Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Oropharynx
• Interventions: Other: questionnaire administration; Procedure: quality-of-life assessment

• Registration Number: NCT01949740
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (patient preferences)	questionnaire administration	Patients participate in a 45-minute interview comprising assessment of priorities and quality of life at baseline, 1, 6, and 12 months.
Observational (patient preferences)	quality-of-life assessment	Patients participate in a 45-minute interview comprising assessment of priorities and quality of life at baseline, 1, 6, and 12 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States