Clinical trial NCT03967379: Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Official title: Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Cancer
Keywords: Other Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility Based on Proportion of Subjects Enrolled
timeFrame: 2 years
Secondary outcomes:
measure: Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups
timeFrame: 8 weeks
measure: Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups
timeFrame: 8 weeks
measure: Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups
timeFrame: 8 weeks
measure: For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups
timeFrame: 8 weeks
measure: For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups
timeFrame: 8 weeks
measure: Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups
timeFrame: 8 weeks
measure: Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups
timeFrame: 8 weeks
measure: Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: