Clinical trial NCT04707937: Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care
Official title: Evaluation of a Brachytherapy Discharge Education Program (BrachDEP) to Improve Patient Care: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Brachytherapy
Vaginal Stenosis
Vaginal Toxicity
Online Education
Health Literacy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction with access to education (CBI)
timeFrame: 1 year
measure: Patient Satisfaction with access to education (EQ-5D-5L)
timeFrame: 1 year
measure: Patient Satisfaction with access to education (EORTC-QOL)
timeFrame: 1 year
measure: Patient Satisfaction with access to education (SVQ)
timeFrame: 1 year
measure: Patient Satisfaction with access to education (PS-CaTE)
timeFrame: 1 year
Secondary outcomes:
measure: Rates of vaginal stenosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Janet Papadakos, PhD, MEd
role: PRINCIPAL_INVESTIGATOR
References: