N/A
Completed N=47
A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Source: ClinicalTrials.gov NCT02492100 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Feasibility Primary Endpoint — 38 Participants
Summary
This research study is evaluating the feasibility and impact of an intervention to improve sexual function in stem cell transplant survivors on participants' sexual function, quality of life, and mood.
- It is expected that about 50 stem cell transplant survivors will take part in this research study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility Primary Endpoint |
38 | — |
| SECONDARY Change in Sexual Function: Promis Sexual Function and Satisfaction Measure |
15.39 | — |
| SECONDARY Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant |
123.88 | — |
| SECONDARY Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9 |
2.33 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients (≥18 years) with hematologic malignancy who underwent an allogeneic HCT at least 6 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 National Comprehensive Cancer Network survivorship guidelines
Exclusion Criteria
- Patients with relapsed disease post-HCT.
- Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient's ability to participate in the informed consent procedures.
Data sourced from ClinicalTrials.gov (NCT02492100). 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.