Gynecologic CancerBrachDEPNCT04707937
Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care
A study testing Online education in people with Gynecologic Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Online education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 19 Aug 2020to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled to receive brachytherapy for treatment of gynecologic cancer at Princess Margaret Cancer Centre.
- Able to provide written informed consent
- Able to read and write in English
- > 18 years of age
Who cannot join
- Not receiving brachytherapy treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Brachytherapy Discharge Education Program (BrachDEP) to Improve Patient Care: A Randomized Control Trial
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.
Read the detailed description
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.
- Conditions
- Gynecologic Cancer
- Being tested
- Online education, Regular standard of care education
- Keywords
- Brachytherapy, Vaginal Stenosis, Vaginal Toxicity, Online Education, Health Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online educationOther
Access to online modules about brachytherapy education in addition to receiving regular standard of care education
Regular standard of care educationOther
Access only to regular standard of care education
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Online education |
| 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) Receives: Other: Regular standard of care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (1)
Rates of vaginal stenosis
To determine whether the online brachytherapy discharge education program:
- Increases patient quality of life
- Improves vaginal dilator compliance
- Reduces rates of vaginal stenosis for gynecological cancer patients post treatment
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start19 Aug 2020
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet Papadakos, PhD, MEd, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707937
- Sponsor's protocol ID
- 19-5955
- Acronym
- BrachDEP
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2020
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Brachytherapy Discharge Education Program (BrachDEP) to Improve Patient Care: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04707937
- Acronym / sponsor ID
- BrachDEP / 19-5955
- Conditions
- Gynecologic Cancer
- Keywords
- Brachytherapy, Vaginal Stenosis, Vaginal Toxicity, Online Education, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online education | Experimental | Other: Online educationParticipants 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 | Other: Regular standard of care educationParticipants only receive current standard of care education (pamphlets and one on one teaching with health care provider) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to receive brachytherapy for treatment of gynecologic cancer at Princess Margaret Cancer Centre.
- Able to provide written informed consent
- Able to read and write in English
- > 18 years of age
Key exclusion criteria (1 listed)
- Not receiving brachytherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online educationAccess to online modules about brachytherapy education in addition to receiving regular standard of care education | Other | Online education |
| Regular standard of care educationAccess only to regular standard of care education | Other | Regular standard of care education |
Primary outcome
Patient Satisfaction with access to education (CBI)
Time frame: 1 year
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
Patient Satisfaction with access to education (EQ-5D-5L)
Time frame: 1 year
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
Patient Satisfaction with access to education (EORTC-QOL)
Time frame: 1 year
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
Patient Satisfaction with access to education (SVQ)
Time frame: 1 year
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
Patient Satisfaction with access to education (PS-CaTE)
Time frame: 1 year
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 secondary outcome
Rates of vaginal stenosis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Papadakos, PhD, MEd principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online education in people with Gynecologic Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction with access to education (CBI) (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.