Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care (BrachDEP)

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Other: Online education; Other: Regular standard of care education

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Online education; Access to online modules about brachytherapy education in addition to receiving regular standard of care education
Active Comparator: Regular standard of care education; Participants only receive current standard of care education (pamphlets and one on one teaching with health care provider)	Other: Regular standard of care education; Access only to regular standard of care education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Janet Papadakos, PhD, MEd, Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): December 5, 2025
• Study Completion (Actual): December 5, 2025

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Health Literacy; Brachytherapy; Online Education; Vaginal Stenosis; Vaginal Toxicity
• Other Study ID Numbers: 19-5955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No