Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care

Gynecologic Cancer Clinical Trial

— BrachDEP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04707937
• Other study ID #: 19-5955
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Other:
• Online education
Access to online modules about brachytherapy education in addition to receiving regular standard of care education
• Regular standard of care education
Access only to regular standard of care education

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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