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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction
• Intervention / Treatment: Behavioral: Multi-modality sexual dysfunction intervention

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 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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multi-modality sexual dysfunction intervention; - Patients in remission > 6 months after allogeneic bone marrow transplant; Patient Enrollment and Baseline Data Collection; First Intervention Visit:Comprehensive assessment of sexual dysfunctionNormalization & EducationTherapeutic interventionsReferral to Sexual Health Clinic if applicable; Follow-Up Intervention Visit --- Referral to Sexual Health Clinic if applicable

Behavioral: Multi-modality sexual dysfunction intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 10, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Sexual Dysfunction Post-Bone Marrow Transplant
• Other Study ID Numbers: 15-158