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

Mass General Brigham

Status: Active, not recruiting

Conditions: Other Cancer

Treatments: Behavioral: Mobile App + enhanced standard care; Other: Enhanced Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03967379

19-104

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Mobile app plus enhanced standard care

Experimental group

Description:

* 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.

Treatment:

Behavioral: Mobile App + enhanced standard care

Other: Enhanced Standard Care

Enhanced Standard Care

Other group

Description:

* 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

Treatment:

Other: Enhanced Standard Care