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NCT Number: NCT04707937

Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care

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.

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Key information

Conditions

Gynecologic Cancer

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Not receiving brachytherapy treatment

Treatment and study plan

Online education

Other

Access to online modules about brachytherapy education in addition to receiving regular standard of care education

Regular standard of care education

Other

Access only to regular standard of care education

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Rates of vaginal stenosis

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Evaluation of a Brachytherapy Discharge Education Program (BrachDEP) to Improve Patient Care: A Randomized Control Trial

Acronym: BrachDEP

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2021
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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