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

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ClinicalTrials.gov Identifier: NCT04707937
Recruitment Status : Enrolling by invitation
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Other: Online education Other: Regular standard of care education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Brachytherapy Discharge Education Program (BrachDEP) to Improve Patient Care: A Randomized Control Trial
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

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




Primary Outcome Measures :
  1. Patient Satisfaction with access to education (CBI) [ Time Frame: 1 year ]

    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


  2. Patient Satisfaction with access to education (EQ-5D-5L) [ Time Frame: 1 year ]

    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


  3. Patient Satisfaction with access to education (EORTC-QOL) [ Time Frame: 1 year ]

    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


  4. Patient Satisfaction with access to education (SVQ) [ Time Frame: 1 year ]

    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


  5. Patient Satisfaction with access to education (PS-CaTE) [ Time Frame: 1 year ]

    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



Secondary Outcome Measures :
  1. Rates of vaginal stenosis [ Time Frame: 1 year ]

    To determine whether the online brachytherapy discharge education program:

    1. Increases patient quality of life
    2. Improves vaginal dilator compliance
    3. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gynecological cancer patients receiving brachytherapy treatment
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707937


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Janet Papadakos, PhD, MEd Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04707937    
Other Study ID Numbers: 19-5955
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Brachytherapy
Vaginal Stenosis
Vaginal Toxicity
Online Education
Health Literacy