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

Tongue Cancer Clinical Trial

Official title:

Patient Preferences in Head and Neck Cancer Treatment Decisions - a Pilot Study of the Durability of Patient Priorities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01949740
• Other study ID #: 13-0552
• Secondary ID: NCI-2013-01181IR
• Status: Terminated
• Phase: N/A
• First received: September 20, 2013
• Last updated: September 1, 2015
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oropharyngeal Neoplasms
• 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

Intervention

Other:
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability of HNPS ranking between pre- and post-treatment assessments	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%.	Up to 12 months	No
Secondary	Reliability of HNPPQ scale, in terms of test-retest and internal consistency	Weighted kappa coefficients will serve as the measure of agreement between the two replicates. Cronbach's alpha will be used to assess internal consistency.	Up to 12 months	No
Secondary	Validity of HNPOS	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.	Up to 12 months	No