Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT02492100
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
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.
Time frame: Baseline to 6 Months
Interest in sex at 6 months, raw score range 2-20 with higher scores indicating higher interest.
Time frame: Baseline to 6 Months
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.
Time frame: Baseline to 6 Months
change in HADS depression score, depression subscale of the HADS has a score range of 0-21, with higher scores indicating more depression symptoms.
Massachusetts General Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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