Online Education Program for Gynecologic Cancer Care

(BrachDEP Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Not receiving brachytherapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Brachytherapy, Internal Radiation Therapy, Radioactive Seed Implantation, Online education for gynecologic cancer care?

Research shows that brachytherapy, a type of internal radiation therapy, is crucial in treating gynecologic cancers and has improved outcomes with less side effects due to advances in technology. Additionally, simulation-based education has been shown to boost confidence and competence in medical professionals, which can enhance the delivery of brachytherapy. ^{1 2 3 4 5}

Is the Online Education Program for Gynecologic Cancer Care safe for humans?

Research on treatments like Brachytherapy and Radioactive Seed Implantation, which are related to the program, shows that safety procedures and guidelines are in place to ensure they are safe for humans. These treatments have been used safely in various conditions, including gynecological tumors, with established protocols to manage and monitor their use. ^{6 7 8 9 10}

How is brachytherapy different from other treatments for gynecologic cancer?

Brachytherapy is unique because it involves placing radioactive material directly inside or near the tumor, allowing for a high dose of radiation to target the cancer while minimizing exposure to surrounding healthy tissue. This internal approach can lead to better outcomes and less toxicity compared to external radiation treatments. ^{1 5 8 11 12}

What is the purpose of this 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.

Research Team

Janet Papadakos, PhD, MEd

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

This trial is for adults over 18 who can read and write in English, diagnosed with gynecologic cancer, and scheduled to receive brachytherapy at Princess Margaret Cancer Centre. They must be able to give informed consent. Those not undergoing brachytherapy are excluded.

Inclusion Criteria

Able to read and write in English

I am scheduled for brachytherapy at Princess Margaret Cancer Centre for gynecologic cancer.

I am scheduled for brachytherapy at Princess Margaret Cancer Centre for gynecologic cancer.

Exclusion Criteria

I am not undergoing brachytherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brachytherapy and are provided with either the online education program or standard care education

Duration not specified

In-person visits for brachytherapy sessions

Education Intervention

Participants in the experimental arm receive access to online education modules in addition to standard care education

Throughout treatment

Follow-up

Participants are monitored for patient satisfaction, quality of life, and vaginal stenosis post-treatment

1 year

Regular follow-up visits and assessments

Treatment Details

Interventions

• Brachytherapy
• Online education

Trial Overview The study is testing a new online education program (BrachDEP) against the regular standard of care education for patients receiving brachytherapy for gynecologic cancers. The goal is to improve self-management and reduce vaginal toxicity post-treatment.

Participant Groups

Group I: Online education Experimental Treatment 1 Intervention

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)

Group II: Regular standard of care education Active Control 1 Intervention

Participants only receive current standard of care education (pamphlets and one on one teaching with health care provider)

Brachytherapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Approved in European Union as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer
• Brain tumors

Approved in Canada as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Education in gynecological brachytherapy. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

The impact of a vaginal brachytherapy boost to pelvic radiation in stage III endometrial cancer. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Patient Reported Outcomes for Women Undergoing Definitive Chemoradiation for Gynecologic Cancer: A Prospective Clinical Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Does brachytherapy improve survival in addition to external beam radiation therapy in patients with high risk stage I and II endometrial carcinoma? [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Simulation-based learning for enhanced gynecologic brachytherapy training among radiation oncology residents. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Brachytherapy patient safety events in an academic radiation medicine program. [2019]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety and efficacy of 3D-printed templates assisted CT-guided radioactive iodine-125 seed implantation for the treatment of recurrent cervical carcinoma after external beam radiotherapy. [2021]

8. China pubmed.ncbi.nlm.nih.gov

[Short- and medium-term clinical effects of CT guided (125)I radioactive seeds implantation in treatment of recurrent/metastatic malignant pelvic tumors]. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Procedures for radioactive I-125 seed implants. [2019]

10. India pubmed.ncbi.nlm.nih.gov

Comparison of three-dimensional-printed template-guided and traditional implantation of 125I seeds for gynecological tumors: A dosimetric and efficacy study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Impact of High-Dose-Rate Brachytherapy Training via Telehealth in Low- and Middle-Income Countries. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

High dose-rate intracavitary brachytherapy for cervical carcinomas with lower vaginal infiltration. [2019]