Trial Outcomes & Findings for Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors (NCT NCT03967379)

NCT ID: NCT03967379

Last Updated: 2025-02-04

Results Overview

feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2025-02-04

Participant Flow

Participant milestones

Measure	Mobile App Plus Enhanced Standard Care * Patients will received enhanced standard care in addition to access to the sexual health mobile app. * The app will also prompt patients to engage their partners with specific exercises. Mobile App + enhanced standard care: An intervention to help address sexual dysfunction among HCT survivors Enhanced Standard Care: Standard of care administered by the institution	Enhanced Standard Care * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
Overall Study STARTED	30	30
Overall Study COMPLETED	24	22
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Baseline characteristics by cohort

Measure	Mobile App Plus Enhanced Standard Care n=30 Participants * Patients will received enhanced standard care in addition to access to the sexual health mobile app. * The app will also prompt patients to engage their partners with specific exercises. Mobile App + enhanced standard care: An intervention to help address sexual dysfunction among HCT survivors Enhanced Standard Care: Standard of care administered by the institution	Enhanced Standard Care n=30 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution	Total n=60 Participants Total of all reporting groups
Age, Continuous	54.5 Years n=5 Participants	57.7 Years n=7 Participants	57.2 Years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized White	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: This is the total number of patients identified as eligible for the study (to reflect feasibility metric)

feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study.

Outcome measures

Measure	Total Study Sample n=95 Participants The entire cohort	Enhanced Standard Care * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
Feasibility Based on Proportion of Subjects Enrolled	60 Participants	—

SECONDARY outcome

Timeframe: 8 weeks

Population: comparison of outcomes at week-8

patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (raw score range 4-25). We will use raw score for reporting in this study given the extent of illness in this population.

Outcome measures

Measure	Total Study Sample n=30 Participants The entire cohort	Enhanced Standard Care n=30 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups	14.6 score on a scale Interval 12.8 to 16.4	12.3 score on a scale Interval 10.5 to 14.1

SECONDARY outcome

Timeframe: 8 weeks

compare patient-reported interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain). higher score indicate better interest in sex (raw score range 2-10).

Outcome measures

Measure	Total Study Sample n=30 Participants The entire cohort	Enhanced Standard Care n=30 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups	6.70 score on a scale Interval 6.1 to 7.4	5.7 score on a scale Interval 5.0 to 6.4

SECONDARY outcome

Timeframe: 8 weeks

compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (raw score range 3-15).

Outcome measures

Measure	Total Study Sample n=30 Participants The entire cohort	Enhanced Standard Care n=30 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups	9.7 score on a scale Interval 8.4 to 10.8	8.3 score on a scale Interval 7.0 to 9.5

SECONDARY outcome

Timeframe: 8 weeks

for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (raw score range 0-55)

Outcome measures

Measure	Total Study Sample n=18 Participants The entire cohort	Enhanced Standard Care n=18 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups	36.6 score on a scale Interval 30.2 to 42.9	27.9 score on a scale Interval 21.3 to 34.5

SECONDARY outcome

Timeframe: 8 weeks

For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain). higher score indicate better lubrication (raw score 0-25)

Outcome measures

Measure	Total Study Sample n=12 Participants The entire cohort	Enhanced Standard Care n=12 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups	13.5 score on a scale Interval 10.4 to 16.4	12.1 score on a scale Interval 9.3 to 14.9

SECONDARY outcome

Timeframe: 8 weeks

compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). higher score indicate better quality of life (range 0-196)

Outcome measures

Measure	Total Study Sample n=30 Participants The entire cohort	Enhanced Standard Care n=30 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups	115.6 score on a scale Interval 110.8 to 120.4	108.3 score on a scale Interval 103.3 to 113.2

SECONDARY outcome

Timeframe: 8 weeks

compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21)

Outcome measures

Measure	Total Study Sample n=30 Participants The entire cohort	Enhanced Standard Care n=30 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups	3.6 score on a scale Interval 2.6 to 4.6	5.4 score on a scale Interval 4.3 to 6.4

SECONDARY outcome

Timeframe: 8 weeks

compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21)

Outcome measures

Measure	Total Study Sample n=30 Participants The entire cohort	Enhanced Standard Care n=30 Participants * Patients will receive Enhanced Standard Care * Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD * Patients will not have access to the sexual health mobile app Enhanced Standard Care: Standard of care administered by the institution
Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups	4.5 score on a scale Interval 3.3 to 5.7	6.4 score on a scale Interval 5.1 to 7.7

Adverse Events

Mobile App Plus Enhanced Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 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: 617-724-4000

Email: ael-jawahri@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place