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Trial registered on ANZCTR


Registration number
ACTRN12620001027909
Ethics application status
Approved
Date submitted
27/07/2020
Date registered
9/10/2020
Date last updated
20/05/2021
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] 301893 0
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 318397 0
sexual health 318398 0
human papillomavirus 318712 0
Condition category
Condition code
Cancer 316412 316412 0 0
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] 318178 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324566 0
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] 324566 0
Baseline, completion of (chemo)radiotherapy, and 3 months, 12 months (primary endpoint) and 24 months following completion of (chemo)radiotherapy.
Primary outcome [2] 324866 0
Determine sociodemographic, patient-reported and treatment factors associated with variations in the sexual satisfaction scale of the EORTC QLQ-SHQ-22
Timepoint [2] 324866 0
Baseline and 12 months following completion of (chemo)radiotherapy
Primary outcome [3] 325167 0
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] 325167 0
Baseline and 12 months following completion of (chemo)radiotherapy
Secondary outcome [1] 384984 0
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] 384984 0
24 months following completion of (chemo)radiotherapy
Secondary outcome [2] 386021 0
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] 386021 0
Baseline and 12 months following completion of (chemo)radiotherapy
Secondary outcome [3] 386022 0
To report quality of life trajectories in human papillomavirus-assocated oropharyngeal cancer survivors treated with (chemo)radiation using the EORTC QLQ-C30
Timepoint [3] 386022 0
Baseline, completion of (chemo)radiotherapy, and 3 months, 12 months and 24 months following completion of (chemo)radiotherapy.
Secondary outcome [4] 386023 0
To report symptom burden trajectories in human papillomavirus-assocated oropharyngeal cancer survivors treated with (chemo)radiation using the MDASI-HN instrument
Timepoint [4] 386023 0
Baseline, completion of (chemo)radiotherapy, and 3 months, 12 months and 24 months following completion of (chemo)radiotherapy.
Secondary outcome [5] 386024 0
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] 386024 0
Baseline, completion of (chemo)radiotherapy, and 3 months, 12 months and 24 months following completion of (chemo)radiotherapy.
Secondary outcome [6] 386025 0
Self-reported resilience using the Connor Davidson Resilience Scale
Timepoint [6] 386025 0
Baseline
Secondary outcome [7] 386026 0
Self-reported predispositional optimism using the Life Orientation Test-Revised
Timepoint [7] 386026 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17156 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 17157 0
Peter Maccallum Cancer Centre - Moorabbin Campus - Bentleigh East
Recruitment postcode(s) [1] 30837 0
3000 - Melbourne
Recruitment postcode(s) [2] 30838 0
3165 - Bentleigh East

Funding & Sponsors
Funding source category [1] 306307 0
Hospital
Name [1] 306307 0
Peter MacCallum Cancer Centre
Address [1] 306307 0
305 Grattan Street
Melbourne, Victoria, Australia, 3000
Country [1] 306307 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street
Melbourne, Victoria, Australia, 3000
Country
Australia
Secondary sponsor category [1] 306802 0
None
Name [1] 306802 0
N/A
Address [1] 306802 0
N/A
Country [1] 306802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306522 0
Peter MacCallum Cancer Centre Human Research Ethics and Governance Committee
Ethics committee address [1] 306522 0
305 Grattan Street
Melbourne, Victoria, Australia, 3000
Ethics committee country [1] 306522 0
Australia
Date submitted for ethics approval [1] 306522 0
Approval date [1] 306522 0
24/06/2020
Ethics approval number [1] 306522 0

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 104154 0
Dr Lachlan McDowell
Address 104154 0
Department of Radiation Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne, Victoria, Australia, 3000
Country 104154 0
Australia
Phone 104154 0
+61 3 85597789
Fax 104154 0
Email 104154 0
lachlan.mcdowell@petermac.org
Contact person for public queries
Name 104155 0
Dr Lachlan McDowell
Address 104155 0
Department of Radiation Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne, Victoria, Australia, 3000
Country 104155 0
Australia
Phone 104155 0
+61 3 85597789
Fax 104155 0
Email 104155 0
lachlan.mcdowell@petermac.org
Contact person for scientific queries
Name 104156 0
Dr Lachlan McDowell
Address 104156 0
Department of Radiation Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne, Victoria, Australia, 3000
Country 104156 0
Australia
Phone 104156 0
+61 3 85597789
Fax 104156 0
Email 104156 0
lachlan.mcdowell@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified patient data including demographic data and results from questionnaires
When will data be available (start and end dates)?
Data will be available for up to 5 years after completion of the study (finalisation of all publications)
Available to whom?
Case by case subject to approval by Principal Investigator and sponsor (lachlan.mcdowell@petermac.org)
Available for what types of analyses?
Data queries from journal editors, systematic reviews, collaborations with questionnaire developers
How or where can data be obtained?
Subject to approvals by Principal Investigator (lachlan.mcdowell@petermac.org)
What supporting documents are/will be available?
No other documents available
Summary results
No Results