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

Mass General Brigham

Status: Completed

Conditions: Sexual Dysfunction

Treatments: Behavioral: Multi-modality sexual dysfunction intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02492100

15-158

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

47 participants in 1 patient group

Multi-modality sexual dysfunction intervention

Experimental group

Description:

- 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

Treatment:

Behavioral: Multi-modality sexual dysfunction intervention