A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Conditions
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Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Multi-modality sexual dysfunction intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-modality sexual dysfunction intervention<br>- Patients in remission > 6 months after allogeneic bone marrow transplant Patient Enrollment and Baseline Data Collection First Intervention Visit: Comprehensive assessment of sexual dysfunction Normalization & Education Therapeutic interventions Referral to Sexual Health Clinic if applicable Follow-Up Intervention Visit --- Referral to Sexual Health Clinic if applicable | Behavioral: Multi-modality sexual dysfunction intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility Primary Endpoint | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sexual Function: Promis Sexual Function and Satisfaction Measure | Interest in sex at 6 months, raw score range 2-20 with higher scores indicating higher interest. | Baseline to 6 Months | 
| Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant | quality of life at 6 months compared to baseline using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant. Score range 0-164 with higher score indicating better quality of life. | Baseline to 6 Months | 
| Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9 | change in HADS depression score, depression subscale of the HADS has a score range of 0-21, with higher scores indicating more depression symptoms. | Baseline to 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Dysfunction Post-Bone Marrow Transplant