Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care
NCT ID: NCT04707937
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2020-08-19
2025-12-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Online education
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)
Online education
Access to online modules about brachytherapy education in addition to receiving regular standard of care education
Regular standard of care education
Participants only receive current standard of care education (pamphlets and one on one teaching with health care provider)
Regular standard of care education
Access only to regular standard of care education
Interventions
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Online education
Access to online modules about brachytherapy education in addition to receiving regular standard of care education
Regular standard of care education
Access only to regular standard of care education
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent
* Able to read and write in English
* \> 18 years of age
Exclusion Criteria
18 Years
100 Years
FEMALE
Yes
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Janet Papadakos, PhD, MEd
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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19-5955
Identifier Type: -
Identifier Source: org_study_id