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

Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492100
• Other study ID #: 15-158
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sexual Dysfunction

Intervention

Behavioral:
• Multi-modality sexual dysfunction intervention

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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