NCT03803696

Multimodal Sexual Dysfunction Intervention In HCT

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 120 people who have undergone a stem cell transplant 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 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. .

Conditions

• Hematopoietic Stem Cell Transplantation
• Hematologic Diseases
• Sexual Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced Standard Care	* Baseline data collection, registration and randomization * Inform primary transplant clinician of sexual dysfunction causing distress * Receive American Cancer Society sexual educational material
BEHAVIORAL	Multimodal Intervention to Address Sexual Dysfunction	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

Timeline

• Start date: 2019-02-01
• Primary completion: 2023-01-01
• Completion: 2025-12-31
• First posted: 2019-01-15
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States