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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02657850

Registration number

NCT02657850

Ethics application status

Date submitted

11/01/2016

Date registered

18/01/2016

Titles & IDs

Public title

Head and Neck Cancer Treatment Related Dysphagia

Scientific title

Multi-Institution Longitudinal Evaluation of Head and Neck Cancer Treatment - Related Dysphagia

Secondary ID [1]

IRB00074509

Secondary ID [2]

J1670

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Head and Neck Cancer

Dysphagia

Condition category

Condition code

Cancer

Head and neck

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Other interventions - non- head and neck self reporting
Other interventions - head neck self reporting
Other interventions - provider reporting

control cohort - study subject self-reporting - Participants who have another cancer (not head and neck cancer) and undergoing treatment will self-report their dysphagia symptoms.

study cohort - study subject self-reporting - Participants who have head and neck cancer and undergoing treatment will self-report their dysphagia symptoms.

study cohort - provider reporting - Participants who have head and neck cancer and undergoing treatment will have their dysphagia symptoms reported by the provider.

Other interventions: non- head and neck self reporting
non- head and neck patient self reports dysphagia symptoms

Other interventions: head neck self reporting
head and neck patient self reports dysphagia symptoms

Other interventions: provider reporting
provider reports on head and neck cancer patients' dysphagia symptoms

Intervention code [1]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Change in rate of dysphagia symptoms

Timepoint [1]

24 months

Secondary outcome [1]

Change in rate of dysphagia between non head and neck and head and neck patients

Timepoint [1]

24 months

Secondary outcome [2]

change in dysphagia across different patient treatments

Timepoint [2]

24 months

Secondary outcome [3]

change in dysphagia across different patient treatments

Timepoint [3]

24 months

Secondary outcome [4]

change in dysphagia across different patient treatments

Timepoint [4]

24 months

Secondary outcome [5]

change in dysphagia across different patient treatments

Timepoint [5]

24 months

Secondary outcome [6]

change in dysphagia across different patient treatments

Timepoint [6]

24 months

Secondary outcome [7]

change in rate of secondary treatment side effect

Timepoint [7]

24 months

Secondary outcome [8]

change in rate of secondary treatment side effect

Timepoint [8]

24 months

Secondary outcome [9]

change in rate of secondary treatment side effect

Timepoint [9]

24 months

Eligibility

Key inclusion criteria

Inclusion Criteria - Head and Neck Cancer Study Subjects:

1. Previously untreated head and neck cancer of any histology receiving treatment with curative oncologic intent regardless of the treatment modality.
2. Capable of providing informed consent.

Inclusion Criteria - Non-Head and Neck Cancer Study Subjects

1. Previously untreated cancer of any histology with no prior history of swallowing disorder and receiving radiation or concurrent chemoradiation or chemotherapy followed by radiation or concurrent chemoradiation.
2. Screening SSQ <234 prior to any cancer treatment.
3. Capable of providing informed consent.

Minimum age

18 Years

Maximum age

100 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Exclusion Criteria -

1. Potential study subjects who are unwilling or unable to be adherent to longitudinal assessment and follow-up. This will include potential study subjects who have poor performance status at the time of study enrollment evaluation.
2. Potential study subjects who have cognitive limitations / impairments that prevent a potential study subject's ability to provide self-reporting with the SSQ instrument and/or other data elements required as described in the study calendar.
3. Potential study subjects who have motor skill limitations that prevent a potential study subject's ability to provide self-reporting with the SSQ instrument and/or other data elements required as described in the study calendar.

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Withdrawn

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

9/06/2016

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

8/06/2017

Sample size

Target

Accrual to date

Final

0

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

University of New South Wales - St. George Hospital - Sydney

Recruitment postcode(s) [1]

- Sydney

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Arizona

Country [2]

United States of America

State/province [2]

Colorado

Country [3]

United States of America

State/province [3]

Minnesota

Country [4]

United States of America

State/province [4]

Missouri

Country [5]

United States of America

State/province [5]

New York

Country [6]

United States of America

State/province [6]

Washington

Country [7]

Canada

State/province [7]

Ontario

Country [8]

China

State/province [8]

Hong Kong

Funding & Sponsors

Primary sponsor type

Other

Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

Cancers located in the upper aerodigestive tract of the head and neck region present unique management challenges due to the crucial functions in this anatomic region along with its anatomic density. As such, cancers themselves and the actual treatment can affect these functions. Of these, the ability to effectively and safely transport a swallow bolus from the oral cavity to the esophagus is particularly important. This consideration has in fact been a major source of debate regarding the optimal management for head and neck cancers as both oncologic-effective and function-preserving therapies are desired. Accomplishing this therapeutic goal has been elusive and can be attributed to a lack of tools that effectively and longitudinally evaluate swallow function over the course of a treatment and in follow-up. As such, investigators surprisingly lack a clear understanding of the natural history of treatment -related swallow dysfunction (dysphagia) regardless of the treatment modality. As such, understanding the prevalence of this significant complication is in fact not well established. Understanding the true prevalence of treatment-related dysphagia is in fact critical to establish as it will help guide decisions as to whether or not treatment strategies require modification including de-intensification of treatment that is receiving considerable attention for favourable prognosis patients associated with the human papillomavirus (HPV).

To address this problem, winvestigators hypothesize that the quantitative and validated patient-reported outcome (PRO) instrument, the Sydney Swallow Questionnaire (SSQ), can be an effective tool to longitudinally measure swallow function to determine the natural history of head and neck cancer treatment-related swallow dysphagia. The SSQ is particularly well suited for longitudinal evaluation of swallow function as it quantifies various aspect of patient-perceived swallow function in contrast to other swallow PROs that measure the impact of swallow function on quality of life domains. To determine the two-year prevalence of dysphagia, investigators will employ a multi-institution prospective study design using our Oncospace® web-portal to facilitate secure prospective data curation and analysis that will include evaluations before, during and following standard of care definitive cancer treatment for a total of 36 months in the follow-up period.

Trial website

https://clinicaltrials.gov/study/NCT02657850

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Harry Quon, M.D.

Address

The SKCCC at Johns Hopkins

Country

Phone

Fax

Email

Contact person for public queries

Name

Address

Country

Phone

Fax

Email

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

When will data be available (start and end dates)?

Available to whom?

Available for what types of analyses?

How or where can data be obtained?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02657850