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

This study has been terminated.
(Poor accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01949740
First Posted: September 24, 2013
Last Update Posted: September 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago
  Purpose
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.

Condition Intervention
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 Other: questionnaire administration Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Preferences in Head and Neck Cancer Treatment Decisions - a Pilot Study of the Durability of Patient Priorities

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Stability of HNPS ranking between pre- and post-treatment assessments [ Time Frame: 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:
  • Reliability of HNPPQ scale, in terms of test-retest and internal consistency [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 37
Study Start Date: June 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949740


Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Investigators
Principal Investigator: Alexander Langerman University of Chicago Comprehensive Cancer Center
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01949740     History of Changes
Other Study ID Numbers: 13-0552
NCI-2013-01181 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB13-0552
P30CA014599 ( U.S. NIH Grant/Contract )
First Submitted: September 20, 2013
First Posted: September 24, 2013
Last Update Posted: September 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Neoplasms
Mouth Diseases
Tongue Diseases