Multimodal Sexual Dysfunction Intervention In HCT

Study Overview
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Brief Summary
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This research study is evaluating the 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 230 people who have undergone a stem cell transplant 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 Investigators 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 main purpose of this study is to compare two types of care - the study intervention versus enhanced standard care which includes receiving an educational handout about sexual dysfunction. The main goal is to assess if the intervention will improve participant's sexual function, quality of life, and mood. The intervention includes a comprehensive assessment by a transplant clinician (a transplant physician or nurse practitioner) who is trained in sexual dysfunction assessment to explore the reasons for sexual dysfunction and focus on ways to improve symptoms. -- If the transplant clinician feels additional help is needed by a sexual health expert, the participant will be referred to the sexual health clinic. In the sexual health clinic, the participant will be evaluated by an expert physician who will also focus on strategies to improve sexual function. The study will use a series of questionnaires to measure sexual function, quality of life, physical symptoms, and mood. Study questionnaires will be completed in the clinic or remotely with assistance provided as needed. .

Official Title
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Randomized Trial of a Multimodal Sexual Dysfunction Intervention for Hematopoietic Stem Cell Transplant Survivors

Conditions
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Hematopoietic Stem Cell Transplantation, Hematologic Diseases, Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Enhanced Standard Care
* Behavioral: Multimodal Intervention to Address Sexual Dysfunction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (≥ 18 years) with hematologic malignancy who underwent autologous or allogeneic HCT ≥ three months prior to study enrollment. Positive screen for sexual dysfunction that is causing distress based on the National Comprehensive Cancer Network (NCCN) survivorship guidelines Ability to read and respond to questions in English or to complete questionnaires with assistance from an interpreter. Exclusion Criteria: Patients with relapsed disease requiring treatment Patients with a planned second transplant Patients > 5 years from their HCT Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Standard Care<br>Baseline data collection, registration and randomization Inform primary transplant clinician of sexual dysfunction causing distress Receive American Cancer Society sexual educational material | Behavioral: Enhanced Standard Care<br>* Baseline data collection, registration and randomization Inform primary transplant clinician of sexual dysfunction causing distress Receive American Cancer Society sexual educational material<br>|
| Active Comparator: Multimodal Intervention to Address Sexual Dysfunction<br>Baseline data collection, registration and randomization 3 Monthly visits with trained study nurse practitioners Referral to specialist if Psychological etiology Sexual Trauma Relationship Discord Concern for Malignancy or anatomic scarring requiring surgery | Behavioral: Multimodal Intervention to Address Sexual Dysfunction<br>* Baseline data collection, registration and randomization - 3 Monthly visits with trained study nurse practitioners Referral to specialist if Psychological etiology Sexual Trauma Relationship Discord Concern for Malignancy or anatomic scarring requiring surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Patient Global Satisfaction with Sex | compare patients' global satisfaction with sex using PROMIS Sexual Function and Satisfaction Measure (global satisfaction domain) at three months between the study groups using linear regression controlling for baseline values (as necessary for any imbalances in baseline variables | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Patient reported interest in sexual activity | PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain) | 3 Months | 
| Compare Patient global satisfaction with sex longitudinally | compare PROMIS Sexual function and Satisfaction Measure - global satisfaction with sex domain) longitudinally between study groups | up to 9 months | 
| Compare Patient reported interest in sexual activity longitudinally | compare PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain) longitudinally between study groups | up to 9 months | 
| Compare patient-reported orgasm | Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain | 3 Months | 
| Compare patient-reported orgasm longitudinally | Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) longitudinally between the study groups | up to 9 months | 
| For males: compare patient-reported erectile function | PROMIS Sexual Function and Satisfaction Measure - Erectile function domain | 3 Months | 
| For males: compare patient-reported erectile function longitudinally | Compare PROMIS Sexual Function and Satisfaction Measure - Erectile function domain longitudinally between the two groups | up to 9 months | 
| For females: compare patient-reported vaginal lubrication | compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain) | 3 Months | 
| For females: compare patient-reported vaginal lubrication longitudinally | compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain) longitudinally between the two study groups | up to 9 months | 
| For females: compare patient-reported vaginal comfort | compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain | 3 months | 
| For females: compare patient-reported vaginal comfort longitudinally | compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain) longitudinally between the two study groups | up to 9 months | 
| Compare Patient Reported Quality of Life | Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | 3 Months | 
| Compare Patient Reported Quality of Life longitudinally | Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) longitudinally between the two groups | up to 9 months | 
| Compare Patient Reported Anxiety Symptoms | Compare patient reported anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS- anxiety subscale). Subscale ranges from 0-21 with higher score indicating higher anxiety symptoms | 3 Months | 
| Compare Patient Reported Anxiety Symptoms Longitudinally | Compare patient reported anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS- anxiety subscale) longitudinally between the two study groups. Subscale ranges from 0-21 with higher score indicating higher anxiety symptoms | up to 9 months | 
| Compare Patient Reported Depression Symptoms | Compare Patient Reported Depression Symptoms using the Hospital Anxiety and Depression Scale (HADS - depression subscale). Subscale ranges from 0-21 with higher score indicating higher depression symptoms | 3 Months | 
| Compare Patient Reported Depression Symptoms Longitudinally | Compare Patient Reported Depression Symptoms using the Hospital Anxiety and Depression Scale (HADS - depression subscale) longitudinally between the two study groups. Subscale ranges from 0-21 with higher score indicating higher depression symptoms | up to 9 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic Stem Cell Transplantation, Hematologic Diseases, Sexual Dysfunction