Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care

NCT04707937 | Completed

• 1 other identifier: 19-5955
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Gynecologic Cancer

Keywords

Brachytherapy; Vaginal Stenosis; Vaginal Toxicity; Online Education; Health Literacy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Rates of vaginal stenosis

  1 year

Study Arms (2)

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)

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)

Other: Regular standard of care education

Interventions

Online education OTHER

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

Online education

Regular standard of care education OTHER

Access only to regular standard of care education

Regular standard of care education

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Gynecological cancer patients receiving brachytherapy treatment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not receiving brachytherapy treatment

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Study Officials

• Janet Papadakos, PhD, MEd

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: January 13, 2021
• Study Start: August 19, 2020
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)