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Trial registered on ANZCTR


Registration number
ACTRN12624000353594p
Ethics application status
Submitted, not yet approved
Date submitted
6/03/2024
Date registered
27/03/2024
Date last updated
27/03/2024
Date data sharing statement initially provided
27/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Helping clinicians and patients make sense of human papillomavirus (HPV)-related oropharyngeal cancer: implementation of an information resource
Scientific title
Helping clinicians and patients make sense of HPV-related oropharyngeal cancer: assessing the feasibility, acceptability and efficacy of an information resource
Secondary ID [1] 311678 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HPV-related oral squamous cell carcinoma 333138 0
Condition category
Condition code
Cancer 329834 329834 0 0
Head and neck
Public Health 329954 329954 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We designed an evidence-based booklet for HPV-related oral squamous cell carcinoma (HPV-OSCC) patients, informed by interviews with health professionals, patients, and their partners. The booklet contains information about HPV, and the link between HPV and oropharyngeal cancer. It aimed to deliver information in everyday language, and to provide a tool supporting health professionals communicating about HPV-OSCC to patients.

There is no prescribed manner in which clinicians are instructed use the booklet with individuals diagnosed with HPV-OSCC in our study. Instead, the qualitative component of this trial takes an exploratory approach to understanding how clinicians integrate the booklet into their clinical practice, and experiences of this from the perspective of patients and clinicians. However, the booklets will be presented individually to patients and/or their family/friend carers by their treating clinician - this health professional will be a member of the patient's treating team in a medical specialist (e.g., radiation oncologist, head and neck surgeon), nursing, or allied health role. The booklet will be available in hardcopy and/or digital form, depending on the individual's preference, and will be provided at or shortly after diagnosis, and prior to treatment commencement.

We plan to evaluate the booklet with patients and health professionals in a clinical setting - that is, in public or private hospitals/clinics in Australia. The booklet will be evaluated quantitatively and qualitatively; participants will be asked to complete a purpose-designed questionnaire, and will be invited to participate in a semi-structured interview. The questionnaire will facilitate the monitoring of adherence, as well as capture key outcomes (e.g., knowledge of HPV and HPV-related oropharyngeal cancer).

Regarding the semistructured interviews, these will be 45-60minutes in duration and will be audio-recorded with participants' consent. Interviews will be conducted by a member of the research team. We will aim to recruit approximately 20 clinician-participants and 20 patient/carer-participants. No specific sampling strategy will be used - the first 20 participants who opt-in to the additional qualitative component of the study in each participant group will be recruited.
Intervention code [1] 328142 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337602 0
Knowledge/comprehension of the booklet content (patient-participants only)
Timepoint [1] 337602 0
(1) Pre-intervention, (2) post-intervention (i.e., within 1-week of reading booklet), and (3) follow-up (3-months after completing cancer treatment, or later under advice from treating clinician).
Primary outcome [2] 337603 0
Acceptability of the intervention
Timepoint [2] 337603 0
Patient-participants:
(1) Pre-intervention, (2) post-intervention (i.e., within 1-week of reading booklet), and (3) follow-up (3-months after completing cancer treatment, or later under advice from treating clinician).

Clinician-participants:
(1) Pre-implementation of booklet in clinical practice, (2) post-implementation (approximately 6-months after implementation)
Primary outcome [3] 337604 0
Feasibility of the intervention (clinician-participants only)
Timepoint [3] 337604 0
(1) Pre-implementation of the booklet into clinical practice, (2) Post-implementation (approximately six months after implementation)
Secondary outcome [1] 432485 0
Benefit of intervention
Timepoint [1] 432485 0
Patient-participants:
(1) Pre-intervention, (2) post-intervention (i.e., within 1-week of reading booklet), and (3) follow-up (3-months after completing cancer treatment, or later under advice from treating clinician).

Clinician-participants:
(1) Pre-implementation of the booklet into clinical practice, (2) Post-implementation (approximately six months after implementation)
Secondary outcome [2] 432486 0
Appropriateness of intervention
Timepoint [2] 432486 0
Patient-participants:
(1) Pre-intervention, (2) post-intervention (i.e., within 1-week of reading booklet), and (3) follow-up (3-months after completing cancer treatment, or later under advice from treating clinician).

Clinician-participants:
(1) Pre-implementation of the booklet into clinical practice, (2) Post-implementation (approximately six months after implementation)
Secondary outcome [3] 432487 0
Intervention adoption (clinician-participants only)
Timepoint [3] 432487 0
(1) Pre-implementation of the booklet into clinical practice, (2) Post-implementation (approximately six months after implementation)
Secondary outcome [4] 432488 0
Perceived sustainability of the intervention (clinician-participants only)
Timepoint [4] 432488 0
(1) Pre-implementation of the booklet into clinical practice, (2) Post-implementation (approximately six months after implementation)
Secondary outcome [5] 432489 0
Confidence speaking about HPV with patients diagnosed with HPV-OSCC
Timepoint [5] 432489 0
(1) Pre-implementation of the booklet into clinical practice, (2) Post-implementation (approximately six months after implementation)
Secondary outcome [6] 432490 0
Psychological distress (patient-participants only)
Timepoint [6] 432490 0
(1) Pre-intervention, (2) post-intervention (i.e., within 1-week of reading booklet), and (3) follow-up (3-months after completing cancer treatment, or later under advice from treating clinician).
Secondary outcome [7] 432491 0
Fear of cancer recurrence (patient-participants only)
Timepoint [7] 432491 0
(1) Pre-intervention, (2) post-intervention (i.e., within 1-week of reading booklet), and (3) follow-up (3-months after completing cancer treatment, or later under advice from treating clinician).

Eligibility
Key inclusion criteria
Patients:
- Diagnosis of HPV-OSCC, or the family/friend carer of an individual diagnosed with HPV-OSCC
- Aged 18 years or over
- Currently a patient of designated site, or the family/friend carer of a patient of designated site
- Cognitively able to provide informed consent, or supported by a family member, authorised representative or another carer

Clinicians:
Inclusion criteria:
- Currently overseeing the care of people diagnosed with HPV-OSCC
- Currently employed by designated site
- Healthcare professionals involved in a multidisciplinary Head and Neck Cancer team, including but not limited to: Doctors, Nurses, Allied Health Professionals, Psychologists, Social Workers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient exclusion criteria:
- Insufficient English language ability to read and understand the participant information sheet, consent form, or simple English-language health information.

Clinician exclusion criteria:
- Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 316007 0
Other Collaborative groups
Name [1] 316007 0
Sydney Health Partners Implementation Science Academy
Country [1] 316007 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318158 0
None
Name [1] 318158 0
N/A
Address [1] 318158 0
Country [1] 318158 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314831 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 314831 0
https://www.slhd.nsw.gov.au/rpa/research/
Ethics committee country [1] 314831 0
Australia
Date submitted for ethics approval [1] 314831 0
05/02/2024
Approval date [1] 314831 0
Ethics approval number [1] 314831 0

Summary
Brief summary
This study is evaluating the implementation and psychological impacts of an evidence-based booklet designed to assist clinicians with delivering information to individuals diagnosed with HPV-OSCC.

Who is it for?
You may be eligible for this study if you are a patient with a diagnosis of HPV-OSCC, or the family/friend carer of an individual diagnosed with HPV-OSCC. Healthcare professionals who are involved in a multidisciplinary Head and Neck Cancer team and are overseeing the care of patients diagnosed with HPV-OSCC will also be recruited for this study.

Study details
Clinicians will supply the booklet to patients in hardcopy and/or digital form, depending on the patient's preference. The booklet will be provided at or shortly after diagnosis, and prior to treatment commencement. This is an exploratory study to understand how clinicians integrate the booklet into their clinical practice, and patients and clinicians will be asked to complete questionnaires and interviews evaluating their experiences.

Findings from this study will help researchers understand the effectiveness and implementation outcomes of a patient education material in the context of newly diagnosed HPV-OSCC patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132866 0
Dr Rachael Dodd
Address 132866 0
Rm 127A, Edward Ford Building A27, The University of Sydney, NSW, 2006
Country 132866 0
Australia
Phone 132866 0
+61 2 9351 5102
Fax 132866 0
Email 132866 0
rachael.dodd@sydney.edu.au
Contact person for public queries
Name 132867 0
Rachael Dodd
Address 132867 0
Rm 127A, Edward Ford Building A27, The University of Sydney, NSW, 2006
Country 132867 0
Australia
Phone 132867 0
+61 2 9351 5102
Fax 132867 0
Email 132867 0
rachael.dodd@sydney.edu.au
Contact person for scientific queries
Name 132868 0
Rachael Dodd
Address 132868 0
Rm 127A, Edward Ford Building A27, The University of Sydney, NSW, 2006
Country 132868 0
Australia
Phone 132868 0
+61 2 9351 5102
Fax 132868 0
Email 132868 0
rachael.dodd@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Releasing individual participant data is not appropriate for this trial, given the study involves a qualitative component through which participants could be identified by their responses, and also due to the sensitive nature of the topics discussed in this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21814Study protocol  rachael.dodd@sydney.edu.au
21815Informed consent form  rachael.dodd@sydney.edu.au
21816Ethical approval  rachael.dodd@sydney.edu.au



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.