Clinical trial NCT02492100: A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Official title: A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Keywords: Sexual Dysfunction Post-Bone Marrow Transplant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility Primary Endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Change in Sexual Function: Promis Sexual Function and Satisfaction Measure
timeFrame: Baseline to 6 Months
measure: Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant
timeFrame: Baseline to 6 Months
measure: Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9
timeFrame: Baseline to 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: