None listed
Conditions
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
Interventions
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
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.
Sponsors
Peter MacCallum Cancer Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed