A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Feasibility Primary Endpoint
Study Overview
Brief 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.
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 introduction of an intervention focused on improving sexual function may improve a participant's overall care and quality of life.
The intervention includes a comprehensive assessment by a transplant clinician who is trained in sexual dysfunction assessment to explore the reasons for sexual dysfunction and focus on ways to improve the participant's symptoms. The study will use a series of questionnaires to measure a participant's sexual function, quality of life, and mood.
The main purpose of this study is examine whether this intervention is feasible and helpful for participants in terms of improving their symptoms and overall quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Feasibility Primary Endpoint
Time Frame: 6 months
intervention deemed feasible if at least 75% of patients screening positive for sexual dysfunction causing distress agree to participate and at least 80% complete at least one additional follow-up visit. This is not a composite outcome. Study is deemed feasible (yes) if both criteria are met.
Secondary Outcomes
- Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant(Baseline to 6 Months)
- Change in Sexual Function: Promis Sexual Function and Satisfaction Measure(Baseline to 6 Months)
- Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9(Baseline to 6 Months)
Investigators
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital