Stage I Squamous Cell Carcinoma of the OropharynxNCT01949740
Patient Preferences in Making Treatment Decisions in Patients With Stage I-IVA Oropharyngeal Cancer
An observational study of Stage I Squamous Cell Carcinoma of the Oropharynx and Stage II Squamous Cell Carcinoma of the Oropharynx, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Squamous Cell Carcinoma of the Oropharynx, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Oropharynx
- What is being tested?
- questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470
About this study
Official title: Patient Preferences in Head and Neck Cancer Treatment Decisions - a Pilot Study of the Durability of Patient Priorities
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the stability of Head and Neck Priorities Scale (HNPS) ranking between pre- and post-treatment assessments.
SECONDARY OBJECTIVES:
- 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
- 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
- Being tested
- questionnaire administration, quality-of-life assessment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Up to 12 months
Secondary outcomes (2)
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.
Measured: Up to 12 months
Validity of HNPOS
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Squamous Cell Carcinoma of the OropharynxStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexander Langerman, Principal investigator, University of Chicago Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949740
- Sponsor's protocol ID
- 13-0552
- Other IDs
- NCI-2013-01181, IRB13-0552, P30CA014599
- Status last verified
- Sep 2015
- First submitted
- 20 Sep 2013
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preferences in Head and Neck Cancer Treatment Decisions - a Pilot Study of the Durability of Patient Priorities
- ClinicalTrials.gov ID
- NCT01949740
- Acronym / sponsor ID
- 13-0552
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the stability of Head and Neck Priorities Scale (HNPS) ranking between pre- and post-treatment assessments.
SECONDARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (patient preferences) | – | Other: questionnaire administration, Procedure: quality-of-life assessmentPatients participate in a 45-minute interview comprising assessment of priorities and quality of life at baseline, 1, 6, and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Observational (patient preferences) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Observational (patient preferences) |
Primary outcome
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%.
2 secondary outcomes
Reliability of HNPPQ scale, in terms of test-retest and internal consistency
Time frame: Up to 12 months
Validity of HNPOS
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Langerman principal investigator
University of Chicago Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage I Squamous Cell Carcinoma of the Oropharynx and Stage II Squamous Cell Carcinoma of the Oropharynx, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of HNPS ranking between pre- and post-treatment assessments (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.