NCT01949740

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

2.2 years

First QC Date

September 20, 2013

Last Update Submit

September 1, 2015

Conditions

Stage I Squamous Cell Carcinoma of the OropharynxStage II Squamous Cell Carcinoma of the OropharynxStage III Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the OropharynxTongue Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Reliability of HNPPQ scale, in terms of test-retest and internal consistency

    Up to 12 months

  • Validity of HNPOS

    Up to 12 months

Study Arms (1)

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 administrationProcedure: quality-of-life assessment

Interventions

questionnaire administrationOTHER

Ancillary studies

Observational (patient preferences)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Observational (patient preferences)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckTongue Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth NeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Study Officials

  • Alexander Langerman

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

September 24, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

US(1)