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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Chicago
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01949740
First received: September 20, 2013
Last updated: October 14, 2014
Last verified: October 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949740

Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Alexander Langerman    773-702-4036    alangerm@surgery.bsd.uchicago.edu   
Principal Investigator: Alexander Langerman         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Alexander Langerman University of Chicago Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01949740     History of Changes
Other Study ID Numbers: 13-0552, NCI-2013-01181, IRB13-0552, P30CA014599
Study First Received: September 20, 2013
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014