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Although brachytherapy is an effective treatment modality for gynecological cancer, a significant proportion of patients develop late treatment-related vaginal toxicity, negatively impacting their quality of life and limiting recurrent disease detection by preventing adequate clinical examination during the post-treatment surveillance period. Consistent with the literature, results from a study at Princess Margaret revealed that current vaginal toxicity management education and training may be inadequate. The investigators seek to implement and evaluate a new online brachytherapy discharge education program (BrachDEP) to support patient engagement in self-management.
Background:
Brachytherapy is a type of radiation therapy used to treat patients with gynecological cancers. Brachytherapy delivers radiation to cancerous tissue by inserting or placing the radiation next to the target tissue. A common side effect that develops as a result of repeated brachytherapy is fibrosis, a thickening and hardening of tissue, as well as narrowing of the vagina, known as vaginal stenosis. To reduce the impact of vaginal stenosis, vaginal dilation is recommended upon discharge of brachytherapy. Vaginal dilation involves the insertion of a smooth plastic tube into the vagina 3 to 4 times per week. Despite the benefits of vaginal dilation, use of vaginal dilators is low among patients following brachytherapy. This poor adherence to vaginal dilator use may be due to embarrassment, discomfort, and lack of awareness of the benefits to patients.
Objective:
The primary objective of this study is to evaluate the whether an online brachytherapy discharge education program increases patient satisfaction with education and care. Secondary objectives are to determine whether the online education program increases patient quality of life, improves vaginal dilator compliance and reduces rates of vaginal stenosis post-treatment.
Methods:
The research team will use a randomized, controlled trial study design. The impact of the online education program will be identified by comparing the outcomes of participants in the intervention arm against those patients in the control arm. Participants will be recruited and randomized to one of two arms that will determine whether they will receive the education intervention.
Significance The results from this study will be used to improve the brachytherapy discharge education program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online education | Experimental | Participants will gain access to the online education modules in addition to receiving current standard of care education (pamphlets and one on one teaching with health care provider) |
|
| Regular standard of care education | Active Comparator | Participants only receive current standard of care education (pamphlets and one on one teaching with health care provider) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online education | Other | Access to online modules about brachytherapy education in addition to receiving regular standard of care education |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction with access to education (CBI) | To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. CBI: Cancer Behavioural Inventory Brief min score: 12 max score: 108 higher scores indicates greater coping efficacy | 1 year |
| Patient Satisfaction with access to education (EQ-5D-5L) | To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. Health Status min value set: 11111 max value set: 55555 lower value set indicates better health min score: 0% max score: 100% higher percentage indicates best possible health | 1 year |
| Patient Satisfaction with access to education (EORTC-QOL) | To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. Quality of Life min score: 1 max score 100 higher score indicates higher level of functioning | 1 year |
| Patient Satisfaction with access to education (SVQ) | To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. The sexual function vaginal changes questionnaire higher scores indicate better overall sexual functioning | 1 year |
| Patient Satisfaction with access to education (PS-CaTE) | To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. Patient Satisfaction with Cancer Treatment Education min score = 1 max score = 5 higher score indicates greater satisfaction with information | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of vaginal stenosis | To determine whether the online brachytherapy discharge education program:
Will be measured by tracking dilator compliance diary and measuring vaginal toxicity at baseline and 1-year post treatment (Vaginal Morbidity at Gynecological Examination) Higher scores indicate lower vaginal morbidity |
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Inclusion Criteria:
Exclusion Criteria:
Gynecological cancer patients receiving brachytherapy treatment
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| Name | Affiliation | Role |
|---|---|---|
| Janet Papadakos, PhD, MEd | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
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| Regular standard of care education | Other | Access only to regular standard of care education |
|
| 1 year |