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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online education program designed to help individuals manage vaginal side effects after brachytherapy (internal radiation therapy), a common treatment for gynecological cancer. The program aims to simplify self-care and enhance quality of life by reducing issues that may interfere with follow-up exams. Participants will either use the online program alongside standard education or receive only the standard education, such as pamphlets and one-on-one teaching. This trial suits those scheduled to receive brachytherapy for gynecologic cancer at Princess Margaret Cancer Centre and who can read and write in English. As an unphased trial, it offers a unique opportunity to contribute to research that could improve patient education and care.

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 prior data suggests that this online education program is safe for gynecologic cancer care?

Research has shown that brachytherapy is generally safe for patients with gynecological cancer. It effectively targets tumors and often alleviates symptoms like vaginal bleeding. However, some patients may experience side effects later, particularly issues related to the vagina, which can affect quality of life and complicate cancer recurrence checks.

Brachytherapy places radiation close to the tumor, delivering high doses to the affected area while protecting nearby tissues. This targeted approach can reduce overall side effects compared to other radiation therapies. Patients should discuss potential risks and benefits with their healthcare team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the online education program for gynecologic cancer care because it offers a novel approach to patient education. Unlike standard methods, which rely on pamphlets and one-on-one teaching, this program integrates digital modules, making information more accessible and engaging. This method could potentially enhance patient understanding and involvement in their own care, leading to better health outcomes. By making learning more interactive and convenient, the program aims to empower patients in a way traditional education methods might not achieve.

What evidence suggests that this online education program is effective for managing vaginal toxicity in gynecologic cancer care?

Research has shown that online education programs can greatly improve the quality of life for patients with gynecological cancer. Studies have found that these programs enhance body image and overall well-being. A team-based online approach shows promise in supporting cancer survivors during recovery. Additionally, virtual educational programs have successfully removed obstacles to care for women with gynecologic cancers. This trial will compare an online education program with the regular standard of care education. These findings suggest that the online education program under evaluation could effectively help patients manage their health after brachytherapy. ^{6 7 8 9 10}

Who Is on the Research Team?

Janet Papadakos, PhD, MEd

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12492832/

Evaluating the impact of a national virtual continuing ... This study employed a two-level evaluation framework based on the Kirkpatrick Model to assess the effectiveness of a national virtual CPD course ...

2. academic.oup.com academic.oup.com/oncolo/article/30/3/oyaf033/8087942

Development of tele-lifestyle-based multidisciplinary ... A multidisciplinary tele-lifestyle-based survivorship program is a viable strategy to improve quality-of-life in gynecologic cancer survivors ...

3. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(20)30990-2/fulltext

The effectiveness of online interventions for patients with ... Online interventions improved quality of life and body images in patients with gynecological cancer, but there were inconclusive effects on ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e17581

Overcoming barriers in equitable care delivery for women ... Overcoming barriers in equitable care delivery for women with gynecologic cancers: Outcomes and analysis from an educational program on health ...

5. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-024-02391-0

The impact of a continuous care model utilizing a smartphone ... This study aimed to assess the impact of a continuous care model utilizing a smartphone application on quality of life and anxiety levels among gynecologic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11576414/

Brachytherapy for cervical cancer: from intracavitary to ... Brachytherapy for cervical cancer has gradually developed from traditional two-dimensional image-guided technology to three-dimensional image-guided technology.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK562190/

Brachytherapy - StatPearls - NCBI Bookshelf Brachytherapy (BT) is a radiotherapy technique where radioactive devices are inserted near tumors to safely deliver high doses of radiation to eliminate and ...

8. mdpi.com mdpi.com/2075-4426/14/12/1138

Safety and Efficacy of Brachytherapy in Inoperable ... Despite these weaknesses, our clinical results are promising. Vaginal bleeding stopped in 83% of patients, and the recurrence rate was 33.3%. It is important to ...

9. aetna.com aetna.com/cpb/medical/data/300_399/0371.html

Brachytherapy - Medical Clinical Policy Bulletins Han and colleagues (2017) evaluated the survival and pain relief outcomes of the I-seeds implantation brachytherapy in advanced pancreatic cancer patients.

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cnr2.2147

Efficacy and Safety of 125 I Seed Implantation in the ... Some studies have also shown that 125I seed implantation is effective and safe in the treatment of pelvic recurrent cervical cancer following ...