Trial Outcomes & Findings for A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors (NCT NCT02492100)

Last Updated: 2019-11-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

6 months

Results posted on

2019-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Pre and Post Sexual Health Intervention A total of 47 patients who screened positive for sexual dysfunction causing distress agreed to participate in this pre-/post- design single-arm study
Overall Study STARTED	47
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Pre and Post Sexual Health Intervention A total of 47 patients who screened positive for sexual dysfunction causing distress agreed to participate in this pre-/post- design single-arm study
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multi-modality Sexual Dysfunction Intervention n=47 Participants \- 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 Multi-modality sexual dysfunction intervention
Age, Continuous	52.5 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Global satisfaction with sex	16.07 units on a scale STANDARD_DEVIATION 8.16 • n=5 Participants
Interest in sex	10.98 units on a scale STANDARD_DEVIATION 3.88 • n=5 Participants
quality of life	107.98 units on a scale STANDARD_DEVIATION 22.00 • n=5 Participants
Depression (HADS)	4.28 units on a scale STANDARD_DEVIATION 3.10 • n=5 Participants
Anxiety (HADS)	4.59 units on a scale STANDARD_DEVIATION 3.32 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: overall 94% (47 of 50) patients who screened positive for sexual dysfunction agreed to participate in the study and 80% attended at least 2 intervention visits

Outcome measures

Outcome measures
Measure	Single Arm Study n=47 Participants single arm study, pre/post design
Feasibility Primary Endpoint	38 Participants

SECONDARY outcome

Timeframe: Baseline to 6 Months

Interest in sex at 6 months, raw score range 2-20 with higher scores indicating higher interest.

Outcome measures

Outcome measures
Measure	Single Arm Study n=46 Participants single arm study, pre/post design
Change in Sexual Function: Promis Sexual Function and Satisfaction Measure	15.39 units on a scale Standard Deviation 3.69

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study n=46 Participants single arm study, pre/post design
Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant	123.88 units on a scale Standard Deviation 17.10

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study n=46 Participants single arm study, pre/post design
Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9	2.33 units on a scale Standard Deviation 2.56

Adverse Events

Single Arm Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Areej El-Jawahri

Massachusetts General Hospital

Phone: 248-763-3912

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place