Patient Preferences in Making Treatment Decisions in Pati... | NCT01949740

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

NCT01949740

Sponsor

University of Chicago

Status

Terminated

Last Update Posted

Sep 2, 2015Estimated

Enrollment

37Actual

Phase

Not provided

Conditions

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

Interventions

questionnaire administration
quality-of-life assessment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2013-01181	Registry Identifier	CTRP (Clinical Trial Reporting Program)
IRB13-0552
P30CA014599	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor accrual

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 20, 2013

First Submission Date that Met QC Criteria

Sep 20, 2013

First Posted Date

Sep 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2015

Last Update Posted Date

Sep 2, 2015Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Procedure: quality-of-life assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire administration	Other	Ancillary studies	Observational (patient preferences)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Validity of HNPOS

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects will be identified through the Hematology/Oncology and ENT clinics a at their first visit for newly diagnosed Head/ Neck Cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander Langerman	University of Chicago Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago Comprehensive Cancer Center		Chicago	Illinois	60637-1470	United States

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck
D014062	Tongue Neoplasms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009062	Mouth Neoplasms
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014060	Tongue Diseases