Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04707937
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-07-25
First Post:
2020-09-30
Brief Title:
Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Evaluation of a Brachytherapy Discharge Education Program BrachDEP to Improve Patient Care A Randomized Control Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BrachDEP
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None