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

NCT ID: NCT01949740

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (patient preferences)

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

questionnaire administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

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questionnaire administration

Ancillary studies

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

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quality of life assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Langerman

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Comprehensive Cancer Center

Locations

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University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2013-01181

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB13-0552

Identifier Type: -

Identifier Source: secondary_id

P30CA014599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-0552

Identifier Type: -

Identifier Source: org_study_id

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