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Helping clinicians and patients make sense of human papillomavirus (HPV)-related oropharyngeal cancer: implementation of an information resource

Helping clinicians and patients make sense of HPV-related oropharyngeal cancer: assessing the feasibility, acceptability and efficacy of an information resource

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000353594
Enrollment
260
Registered
2024-03-27
Start date
2025-02-24
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026