N/A
Completed N=60
Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Other Cancer
Source: ClinicalTrials.gov NCT03967379 ↗
Enrolled (actual)
60
Serious AEs
—
Results posted
Feb 2025
Primary outcomePrimary: Feasibility Based on Proportion of Subjects Enrolled — 60 Participants
Summary
This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility Based on Proportion of Subjects Enrolled |
60 | — |
| SECONDARY Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups |
14.6; 12.3 | — |
| SECONDARY Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups |
6.70; 5.7 | — |
| SECONDARY Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups |
9.7; 8.3 | — |
| SECONDARY For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups |
36.6; 27.9 | — |
| SECONDARY For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups |
13.5; 12.1 | — |
| SECONDARY Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups |
115.6; 108.3 | — |
| SECONDARY Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups |
3.6; 5.4 | — |
| SECONDARY Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups |
4.5; 6.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03967379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.