Symptoms and General Pathology

All Conditions

Constriction, Pathologic

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)

Participants only receive current standard of care education (pamphlets and one on one teaching with health care provider)

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

Online education

Access only to regular standard of care education

Regular standard of care education

Janet Papadakos, PhD, MEd

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.

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.

Gynecological cancer patients receiving brachytherapy treatment

Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care

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

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

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

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

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

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

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

University Health Network, Toronto

Participants will receive a Hyivy device with both verbal and written instructions. Recommended use is three times per week for 12 weeks and consists of: 10 minutes of heat (37-42ºC) per session and 10 minutes of dilation per session

Intravaginal use of Hyivy device three times per week for 12 weeks, with each use session consisting of: 10 minutes of heat (37-42ºC) and 10 minutes of dilation therapy

Vaginal Dilator Therapy by Hyivy device

Sabrina Collins, BSc

Tea Lulic, PhD

Daniel Glick, MD

The objective of this study is to evaluate the feasibility of using the Hyivy device as a non-hormonal therapy in post-radiation patients with pelvic malignancies

Prior to study enrollment, all prospective participants will have the ability to contact the study team to learn more about the study and be provided with the relevant study-specific information. After being informed about the study and potential risks, all participants giving written informed consent will be assessed for their eligibility for the study, and enrolled participants will undergo a maximum 30-day screening period. On Day 0, eligible participants will start a 12-week use of Hyivy device with one visit on Week 6-7 and another on Week 12. After completing the 12-week intervention period, a virtual follow-up will be conducted on Week 16.

A prospective single-arm pre/post repeated-measures pilot intervention study

Hyivy Device in Post-radiation Patients

Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies

There is no plan to make individual participant data available to other researchers

The usability and satisfaction of the Hyivy device for Hyivy's product development as assessed by study-specific questionnaires ranging from 11 (worst usability and satisfaction) to 55 (best usability and satisfaction)

Changes in quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better state of the patient, while higher scores on the symptom and single-item scales indicate a worse state of the patient.

Changes in sexual function as assessed by the EORTC-SHQ-22. The EORTC-SHQ-22 score range is from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Changes in pelvic pain as assessed by visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

Safety of the Hyivy device assessed by the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)

Adherence to the study regimen as assessed by comparing usage data collected by the Hyivy device to the recommended intervention regimen(adherence rate = # of times of patients did dilation therapy/# of times of patients should do dilation therapy \*100%)

Grand River Hospital

Hyivy Health Inc

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Endometrial Neoplasms

Pathological Conditions, Anatomical

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants in control arm (active comparator) will receive standard vaginal dilator with standard set of instructions for dilator use, including both verbal and written instructions. Recommended dilator use is three-times weekly for ten minutes

Participants in experimental arm will receive standard vaginal dilator with addition of silicone ring with standard set of instructions for dilator use, including both verbal and written instructions. Recommended dilator use is three-times weekly for ten minutes

Addition of silicone band to standard vaginal dilator

Silicone Dilator

Standard Dilator

Danielle M Krause, MD

Margaret R Liotta, DO

Danielle Krause, MD

Margaret Liotta, DO

This is a randomized control trial aimed to decreased radiation-induced vaginal stenosis in patients with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. The intervention is an enhanced vaginal dilator model, including a silicone band placed at the desired depth of dilator insertion. The new model will be compared against the traditional vaginal dilator model used as our institutional standard of care. We hypothesize the enhanced model will improve adherence, correct use and efficacy of vaginal dilator use.

Pelvic radiotherapy and vaginal brachytherapy play an integral role in managing gynecological malignancies, including endometrial and cervical cancer. Radiation-induced vaginal stenosis is a well recognized complication of radiation therapy and can result in painful, inadequate pelvic exams and sexual dysfunction. Current recommendations to prevent and manage vaginal stenosis include regular use of vaginal dilators, with our institutional recommendation being three times weekly for 10 minutes. Compliance varies among studies but is generally perceived to be low. Limited literature exists regarding ways to improve adherence and correct use of vaginal dilators. The goal of this study is to enhance the standard vaginal dilator model to improve patient outcomes. Eligibility includes women with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. Patients will be randomized to either the standard vaginal dilator or an enhanced model. The enhanced dilator model includes the addition of a silicone band placed at the desired depth of vaginal dilator insertion, aimed to aide in correct insertion length. The primary aim of the study is patient adherence to vaginal dilator use. Secondary aims include vaginal length, CTCAE v5.0 grading scale for vaginal stricture, sexual function, self-reported comfort with use, and discomfort during office pelvic exams. Outcomes will be obtained based on physician reporting and patient surveys. All analyses will be completed by a biostatistician in the Clinical Research Office using SAS version 9.4.

Randomized control trial with two arms including control arm and experimental arm

An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial

Number of participants who use the vaginal dilator at least three times per week

Vaginal length (in centimeters) measured using a POP-Q wooden stick

The vaginal stenosis grading scale is an ordinal scale ranging from 0 (no vaginal stenosis) to 3 (severe vaginal stenosis) as defined by the Common Terminology Criteria for Adverse Events Version 5.0 - vaginal stricture.

The female sexual function index (FSFI) is a measure of sexual functioning in women. Scores range from 2 to 36 with higher scores indicating greater functioning. The baseline FSFI score is subtracted from the 12-month follow-up FSFI score for each participant.

Discomfort with pelvic exams is measured using a visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

Discomfort with use of the dilator is measured using a visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

Margaret Liotta

Assistant Professor

Behaviors and Mental Disorders

Pelvic Neoplasms

Quality of Life

The self-questionnaire of 104 questions collected personal and socio-demographics data, global and sexual quality of life characteristics (European Organisation for Research and Treatment of Cancer \[EORTC\] quality of life questionnaires: QLQ-C30 and gynecologic and cervical cancer specific-questionnaire QLQ-CX24), vaginal dilatators and moisturizers use, and barriers and facilitators of their use. Clinical data were extracted from the patients' medical files. Vaginal stenosis was evaluated at 6 weeks after the end of brachytherapy and after 1-year follow-up by in-town gynecologists or in our Institute, and censored in case of complete vaginal obliteration

Questionnaires

Christine KERR, MD

Gynecologic cancer treatments (chemoradiotherapy, brachytherapy and surgery) greatly impact patients' sexual quality of life (QoL). Use of the vaginal dilators may reduce vaginal stenosis. Since 2011, our "Gyn and Co LR" patient education program aims to optimize early care of sexual disorders following treatment of cervical and endometrial cancer.

Pelvic cancer accounts for 38,000 cancer cases in France; among them, 15,500 are gynecologic, i.e. endometrial, ovarian, cervical, vaginal and vulval. In 2017, 8,367 new endometrial cancer cases were reported in France1. Endometrial cancer mostly affects women who already underwent menopause; indeed, the median age at diagnosis is 68 years. Cervical cancer is less frequent, with 2,835 new cases reported in France in 2017, but affects younger women. The incidence peak is reported at 40 years, with a median age at death of around 50 years.

The standard of care for cervical cancer combines chemoradiotherapy with utero-vaginal brachytherapy, followed or not with surgery. For endometrial cancer, post-operative vaginal brachytherapy is recommended for intermediate-risk tumors or following radiotherapy for high-risk patients. However, in both cancer localizations, the combination of external radiation and brachytherapy induces numerous adverse effects affecting the patients' overall and sexual quality of life. Digestive, urinary and sexual disorders reported include abdominal pain, incontinence, cystitis, dyspareunia, vaginal irritation, pain during intercourse. A major adverse effect reported is reduction of vaginal elasticity together with vaginal shrinking (shorter and tighter vagina), up to vaginal stenosis. The EMBRACE study showed in 630 patients with locally-advanced cervical cancer a grade ≥ 2 vaginal stenosis rate of 21% at 2 years. A study reported that among sexually active women, 54% were not satisfied or little satisfied with their sexual activity; about 50% women also reported vaginal dryness and more than 40% pain during penetration. The EMBRACE study reported in locally-advanced cervical cancer patients the persistence of treatment-related symptoms, diarrhea, menopausal symptoms, peripheral neuropathy and sexual functioning problems two years after diagnosis. Vaginal dryness, hot flashes and pain at penetration were reported up to 5 to 10 years after diagnosis in cancer survivors as compared with controls in a case-control study. In endometrial cancer patients, a long-term analysis of the PORTEC-2 study reported vaginal dryness, short or narrow vagina and pain during intercourse at 7 years after treatment.

Studies in psycho-oncology or nursing care have assessed the impact of these disorders and are bringing up some solutions, among which use of vaginal dilators to prevent vaginal stenosis and improve sexual quality of life. International guidelines were issued on the use of vaginal dilators by these patients. Both guidelines and studies assessing patient education interventions to increase the patients' use of the vaginal dilators concluded on the possible benefit of educational programs stenosis prevention. Some programs well integrated in the patients' care pathway have been published. Early interventions starting as soon as the disease announcement consult with the radiation oncologist are still needed to improve vaginal stenosis prevention and the patients' sexual quality of life.

In this context, the investigator have initiated, for the first time in France, the "Gyn and Co LR" patient education program, approved by the Regional Health Agency. This program, fully integrated in the patients' care pathway, aimed to optimize an early care of sexual disorders and prevent vaginal stenosis in patients treated with brachytherapy for cervical or endometrial cancer.

Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.

Vaginal Dilatators and Moisturizers Use and Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.

Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24

Clinical data from the patient medical file

Sexual quality of life questionnaire:EORTC QLQ-CX24

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care	NCT04707937	Gynecologic Can...	Online educatio... Regular standar...	18 Years - 100 Years	University Health Network, Toronto
Hyivy Device in Post-radiation Patients	NCT05648253	Vaginal Stenosi... Radiation Thera... Cancer	Vaginal Dilator...	18 Years -	Hyivy Health Inc
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis	NCT03876860	Endometrial Can... Cervical Cancer Vaginal Strictu... Radiation Toxic...	Silicone Dilato... Standard Dilato...	18 Years -	Loyola University
Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.	NCT04184154	Pelvic Cancer Cervical Cancer	Questionnaires	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care	NCT04707937	Gynecologic Can...	Online educatio... Regular standar...	18 Years - 100 Years	University Health Network, Toronto
Hyivy Device in Post-radiation Patients	NCT05648253	Vaginal Stenosi... Radiation Thera... Cancer	Vaginal Dilator...	18 Years -	Hyivy Health Inc
Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.	NCT04184154	Pelvic Cancer Cervical Cancer	Questionnaires	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

Spots Global Cancer Trial Database for vaginal stenosis