ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12620001027909

Ethics application status

Approved

Date submitted

27/07/2020

Date registered

9/10/2020

Date last updated

28/03/2023

Date data sharing statement initially provided

9/10/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Longitudinal Assessment of Sexual Health in patients with human papillomavirus associated oropharyngeal cancer

Scientific title

Longitudinal Assessment of changes in Sexual Health of patients with human papillomavirus associated oropharyngeal cancer, prior to, during and following chemoradiotherapy or radiotherapy treatment

Secondary ID [1]

Peter Mac No. 20/76

Universal Trial Number (UTN)

Trial acronym

LASH (Longitudinal Assessment of Sexual Health)

Linked study record

Health condition

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

oropharyngeal cancer

sexual health

human papillomavirus

Condition category

Condition code

Cancer

Head and neck

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This patient-reported outcomes study will enrol 100 patients with human papillomavirus-associated oropharyngeal cancer and will longitudinally assess changes in sexual health outcomes using validated quantitative measure (EORTC QLQ-SHQ22) from diagnosis to two years after completion of (chemo)radiotherapy. Patients will also answer validated questionnaires reporting their quality of life (EORTC QLQ-C30), symptom burden (MD Anderson Symptom Inventory - Head and Neck), emotional distress (PROMIS Anxiety and Depression scales), body image (FACE-Q), resilience (Connor Davidson Resilience Scale) and predispositional optimism (Life Orientation Test-Revised). Patients will also undertake an established prioritisation exercise (Chicago Priorities Scale) at baseline and one year after treatment in which patients will arrange the order of the importance of disease and functional outcomes in head and neck cancer populations, including additional item regarding the importance of sexual function.

Assessments will be answered at five times points, including baseline (first week of radiotherapy), at the end of radiotherapy (week 7) and then at 3, 12 and 24 months after treatment using an electronic platform, with the exception of the Chicago priorities scale which will be performed face to face at baseline and 12 months. Assessments will be scheduled at typical follow up schedules, and patients will have option to answer at home on the electronic platform on their own device or at their follow up appointment with a hospital device. Each assessment will take between 20-40 minutes. The total duration of the study will continue for 24 months after completion of (chemo)radiation.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Report changes in sexual health prior to, during and following a course of (chemo)radiotherapy in human papillomavirus-associated oropharyngeal cancer using the EORTC QLQ-SHQ22

Timepoint [1]

Baseline, completion of (chemo)radiotherapy, and 3 months, 12 months (primary endpoint) and 24 months following completion of (chemo)radiotherapy.

Primary outcome [2]

Determine sociodemographic, patient-reported and treatment factors associated with variations in the sexual satisfaction scale of the EORTC QLQ-SHQ-22

Timepoint [2]

Baseline and 12 months following completion of (chemo)radiotherapy

Primary outcome [3]

Determine sociodemographic, patient-reported and treatment factors associated with variations in the importance of sexual activity item of the EORTC QLQ-SHQ-22

Timepoint [3]

Baseline and 12 months following completion of (chemo)radiotherapy

Secondary outcome [1]

Report long-term changes in sexual health following a course of (chemo)radiotherapy in human papillomavirus-associated oropharyngeal cancer using the EORTC QLQ-SHQ22

Timepoint [1]

24 months following completion of (chemo)radiotherapy

Secondary outcome [2]

To report patient-reported preferences of treatment outcome priorities in human papillomavirus-associated oropharyngeal cancer at baseline and follow up using the Chicago Priorities Scale, including a modified sexual function item

Timepoint [2]

Baseline and 12 months following completion of (chemo)radiotherapy

Secondary outcome [3]

To report quality of life trajectories in human papillomavirus-assocated oropharyngeal cancer survivors treated with (chemo)radiation using the EORTC QLQ-C30

Timepoint [3]

Baseline, completion of (chemo)radiotherapy, and 3 months, 12 months and 24 months following completion of (chemo)radiotherapy.

Secondary outcome [4]

To report symptom burden trajectories in human papillomavirus-assocated oropharyngeal cancer survivors treated with (chemo)radiation using the MDASI-HN instrument

Timepoint [4]

Baseline, completion of (chemo)radiotherapy, and 3 months, 12 months and 24 months following completion of (chemo)radiotherapy.

Secondary outcome [5]

To report emotional distress trajectories in human papillomavirus-assocated oropharyngeal cancer survivors treated with (chemo)radiation using the PROMIS Anxiety and Depression scales

Timepoint [5]

Baseline, completion of (chemo)radiotherapy, and 3 months, 12 months and 24 months following completion of (chemo)radiotherapy.

Secondary outcome [6]

Self-reported resilience using the Connor Davidson Resilience Scale

Timepoint [6]

Baseline

Secondary outcome [7]

Self-reported predispositional optimism using the Life Orientation Test-Revised

Timepoint [7]

Baseline

Eligibility

Key inclusion criteria

1. Male or female aged 18 years and over at screening.
2. Received curative-intent CRT/RT for human papillomavirus associated oropharyngeal cancer (based on p16 status).
3. Will be available for routine post treatment follow up
4. Sufficient English literacy to complete study measures

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Evidence of metastatic oropharyngeal cancer
2. Carcinoma of unknown primary
3. Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
4. Medical comorbidities which impact the validity of the study result (sexual health outcomes) e.g. Parkinson’s Disease, recent MI
5. Other active or treated malignancy which may interfere with the validity of results e.g. breast or prostate cancer

Study design

Purpose

Psychosocial

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

A number of validated statistical measures will be employed, including descriptive statistics, median rankings, effect size estimates and regression modelling.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

12/10/2020

Actual

19/10/2020

Date of last participant enrolment

Anticipated

31/12/2021

Actual

18/11/2021

Date of last data collection

Anticipated

14/01/2024

Actual

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [2]

Peter Maccallum Cancer Centre - Moorabbin Campus - Bentleigh East

Recruitment hospital [3]

GenesisCare - St. Vincent's Melbourne - Fitzroy

Recruitment postcode(s) [1]

3000 - Melbourne

Recruitment postcode(s) [2]

3165 - Bentleigh East

Recruitment postcode(s) [3]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Peter MacCallum Cancer Centre

Address [1]

305 Grattan Street Melbourne, Victoria, Australia, 3000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Peter MacCallum Cancer Centre

Address

305 Grattan Street
Melbourne, Victoria, Australia, 3000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre Human Research Ethics and Governance Committee

Ethics committee address [1]

305 Grattan Street
Melbourne, Victoria, Australia, 3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/06/2020

Ethics approval number [1]

Summary

Brief summary

The purpose of this research study is to observe any changes in sexual health that patients may have following the diagnosis and treatment of a head and neck cancer called oropharyngeal cancer (which includes tonsil and base of tongue cancers).

Who is it for?
You may be eligible for this study if you are aged 18 years or older, and you have started chemoradiotherapy or radiotherapy for human papillomavirus (HPV)-associated oropharyngeal cancer in the last week, or are about to start chemoradiotherapy or radiotherapy for HPV-associated oropharyngeal cancer soon.

Participants enrolled in this study will be asked to attend up to five study visits at the Peter MacCallum Cancer Centre, starting from enrolment and continuing each year up until 2 years after they have completed chemoradiotherapy or radiotherapy treatments. Each study visit will take approximately 40 minutes and participants will be asked to complete a series of questionnaires about their sexual health, quality of life, head and neck symptom burden, emotional distress, body image, resilience and levels of optimism. Participants will also be asked to list in order how important sexual function is compared to other functions such as swallowing and eating.  These questionnaires will be administered in either a paper or electronic format and patients will be able to answer the majority of the questionnaires at home, except for the exercise where patients will be asked to order their priorities (sexual function, swallowing, eating) which will be done in the hospital face to face with a member of the study team.  

It is hoped this research may be used to improve health outcomes for future patients with human papillomavirus-associated oropharyngeal cancer by determining how chemoradiotherapy and radiotherapy treatments impacts sexual health and function

Trial website

N/A

Trial related presentations / publications

N/A

Public notes

N/A

Contacts

Principal investigator

Name

Dr Lachlan McDowell

Address

Department of Radiation Oncology Peter MacCallum Cancer Centre 305 Grattan Street Melbourne, Victoria, Australia, 3000

Country

Australia

Phone

+61 3 85597789

Fax

[email protected]

Contact person for public queries

Name

Lachlan McDowell

Address

Department of Radiation Oncology Peter MacCallum Cancer Centre 305 Grattan Street Melbourne, Victoria, Australia, 3000

Country

Australia

Phone

+61 3 85597789

Fax

[email protected]

Contact person for scientific queries

Name

Lachlan McDowell

Address

Department of Radiation Oncology Peter MacCallum Cancer Centre 305 Grattan Street Melbourne, Victoria, Australia, 3000

Country

Australia

Phone

+61 3 85597789

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Case by case subject to approval by Principal Investigator and sponsor ([email protected])

Conditions for requesting access:
• -

What individual participant data might be shared?

• de-identified patient data including demographic data and results from questionnaires

What types of analyses could be done with individual participant data?

• Data queries from journal editors, systematic reviews, collaborations with questionnaire developers

When can requests for individual participant data be made (start and end dates)?

From:
Data will be available for up to 5 years after completion of the study (finalisation of all publications)

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically