Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Study Overview
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Brief Summary
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This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.

Detailed Description
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Frequently survivors of stem cell transplantation report significant problems with their sexual function that impacts their quality of life, mood, and their intimacy and relationship with their partners. These issues can be very distressing to patients and their loved ones. The study doctors want to know if the use of a mobile app intervention focused on improving sexual function may improve participants overall care.

Official Title
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Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Conditions
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Other Cancer

Intervention / Treatment
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* Behavioral: Mobile App + enhanced standard care
* Other: Enhanced Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (≥18 years) who underwent an autologous or allogeneic HCT at least 3 months prior to study enrollment. Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member. Positive screen for sexual dysfunction that is causing distress based on the NCCN survivorship guidelines Exclusion Criteria: Recurrent disease requiring treatment Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile app plus enhanced standard care<br>Patients will received enhanced standard care in addition to access to the sexual health mobile app. The app will also prompt patients to engage their partners with specific exercises. | Behavioral: Mobile App + enhanced standard care<br>* An intervention to help address sexual dysfunction among HCT survivors<br>Other: Enhanced Standard Care<br>* Standard of care administered by the institution<br>|
| Other: Enhanced Standard Care<br>Patients will receive Enhanced Standard Care Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD Patients will not have access to the sexual health mobile app | Other: Enhanced Standard Care<br>* Standard of care administered by the institution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of the intervention | feasibility will be defined if at least 60% of eligible patients enroll and engage with at least 70% of the intervention modules | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare patient-reported global satisfaction with sex (PROMIS Sexual Function and Satisfaction Measure) between the study groups | patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (there is a raw and T score. T score range 0-100) | 8 and 12 weeks | 
| Compare patient-reported interest in sexual activity (PROMIS Sexual Function and Satisfaction Measure - Interest in sexual activity domain) between the study groups | compare patient-reported interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain). higher score indicate better interest in sex (there is a raw and T score, T score range 0-100) | 8 and 12 weeks | 
| Compare patient-reported orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) between the study groups | compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (there is a raw and t-score, t-score range 0-100) | 8 and 12 weeks | 
| For males: compare patient-reported erectile function (PROMIS Sexual Function and Satisfaction Measure - Erectile function domain) between the study groups | for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (there is a raw and t-score, T-score range 0-100) | 8 and 12 weeks | 
| For females: compare patient-reported lubrication and vaginal comfort (PROMIS Sexual Function and Satisfaction Measure - lubrication and vaginal comfort domains) between the study groups | For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain). higher score indicate better lubrication and vagina comfort (there is a raw and T-score, T-score range 0-100) | 8 and 12 weeks | 
| Compare patient reported quality of life (FACT-BMT) between the study groups | compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). higher score indicate better quality of life (range 0-196) | 8 and 12 weeks | 
| Compare patient reported depression symptoms (HADS-depression) between the two study groups | compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21) | 8 and 12 weeks | 
| Compare patient reported anxiety symptoms (HADS-anxiety) between the two study groups | compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21) | 8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Other Cancer