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

Mass General Brigham logo

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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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