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

NCT02492100 | Completed Results

• 1 other identifier: 15-158
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction

Keywords

Sexual Dysfunction Post-Bone Marrow Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Sexual Function: Promis Sexual Function and Satisfaction Measure

  Baseline to 6 Months

• Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant

  Baseline to 6 Months

• Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9

  Baseline to 6 Months

Study Arms (1)

Multi-modality sexual dysfunction intervention

EXPERIMENTAL

\- 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

Behavioral: Multi-modality sexual dysfunction intervention

Interventions

Multi-modality sexual dysfunction intervention BEHAVIORAL

Multi-modality sexual dysfunction intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Areej El-Jawahri
• Organization: Massachusetts General Hospital

ael-jawahri@partners.org

248-763-3912

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 8, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (1)