Multimodal Mobile Intervention Application (App) to Addre... | NCT03967379

NCT03967379

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mobile app plus enhanced standard care	Experimental	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.	Behavioral: Mobile App + enhanced standard care Other: Enhanced Standard Care
Enhanced Standard Care	Other	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	Other: Enhanced Standard Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mobile App + enhanced standard care	Behavioral	An intervention to help address sexual dysfunction among HCT survivors	Mobile app plus enhanced standard care

Outcomes Module

Measure	Description	Time Frame
Feasibility Based on Proportion of Subjects Enrolled	feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups	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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Areej El-Jawahri, MD	Massachusetts General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital Cancer Center		Boston	Massachusetts	02114	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40490014	Derived	Markovitz NH, Traeger L, Vanderklish J, Horick N, Newcomb R, Larizza IS, Boardman AC, DeFilipp Z, Chen YB, Dizon DS, Reese JB, Temel J, Amonoo HL, El-Jawahri A. Sexual Health in Hematopoietic Stem Cell Transplantation Survivors. J Natl Compr Canc Netw. 2025 Jun 9;23(7):e257019. doi: 10.6004/jnccn.2025.7019.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 3, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00030 BG00130 BG00260

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

Years

Title

Denominators

Categories

Title	Measurements
	BG00054.5(24.3 to 75) BG00157.7(27.9 to 77) BG00257.2(24.3 to 77)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00012 BG00112 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00028 BG00129 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00030 BG00130 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Feasibility Based on Proportion of Subjects Enrolled

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

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

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	Total Study Sample	The entire cohort

Units	Counts
Participants	OG00095

Title

Denominators

Categories

Title	Measurements
	OG00060

Secondary

Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups

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.

comparison of outcomes at week-8

Posted

Mean

95% Confidence Interval

score on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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

Secondary

Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups

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).

Posted

Mean

95% Confidence Interval

score on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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

Secondary

Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups

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

Posted

Mean

95% Confidence Interval

score on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups

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)

Posted

Mean

95% Confidence Interval

score on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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

Secondary

For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups

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)

Posted

Mean

95% Confidence Interval

score on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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

Secondary

Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups

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)

Posted

Mean

95% Confidence Interval

score on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups

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

Posted

Mean

95% Confidence Interval

score on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups

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

Posted

Mean

95% Confidence Interval

score on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	0	0	0	0	0
EG001	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	0	0	0	0	0	0

Units	Counts
Participants	OG00030 OG00130