## Protocol Section
### Identification Module
**NCT ID:** NCT03967379

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

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

#### Organization Study ID Info
**ID:** 19-104
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2024-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-27

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-23

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-01-01

**Type:** ACTUAL

#### Start Date
**Date:** 2019-02-01

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2019-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2019-05-27
**Study First Submit QC Date:** 2019-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Investigator Affiliation:** Massachusetts General Hospital

**Investigator Full Name:** El-Jawahri, Areej,M.D.

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.

**Detailed Description:** 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 use of a mobile app intervention focused on improving sexual function may improve participants overall care.

### Conditions Module

**Conditions:**

- Other Cancer

**Keywords:**

- Other Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** * 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.

**Intervention Names:**

- Behavioral: Mobile App + enhanced standard care

- Other: Enhanced Standard Care

**Label:** Mobile app plus enhanced standard care

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** * 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

**Intervention Names:**

- Other: Enhanced Standard Care

**Label:** Enhanced Standard Care

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mobile app plus enhanced standard care

**Description:** An intervention to help address sexual dysfunction among HCT survivors

**Name:** Mobile App + enhanced standard care

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Enhanced Standard Care

- Mobile app plus enhanced standard care

**Description:** Standard of care administered by the institution

**Name:** Enhanced Standard Care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** feasibility will be defined if at least 60% of eligible patients enroll and engage with at least 70% of the intervention modules

**Measure:** To assess the feasibility of the intervention

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (there is a raw and T score. T score range 0-100)

**Measure:** Compare patient-reported global satisfaction with sex (PROMIS Sexual Function and Satisfaction Measure) between the study groups

**Time Frame:** 8 and 12 weeks

**Description:** 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 (there is a raw and T score, T score range 0-100)

**Measure:** Compare patient-reported interest in sexual activity (PROMIS Sexual Function and Satisfaction Measure - Interest in sexual activity domain) between the study groups

**Time Frame:** 8 and 12 weeks

**Description:** compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (there is a raw and t-score, t-score range 0-100)

**Measure:** Compare patient-reported orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) between the study groups

**Time Frame:** 8 and 12 weeks

**Description:** for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (there is a raw and t-score, T-score range 0-100)

**Measure:** For males: compare patient-reported erectile function (PROMIS Sexual Function and Satisfaction Measure - Erectile function domain) between the study groups

**Time Frame:** 8 and 12 weeks

**Description:** 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 and vagina comfort (there is a raw and T-score, T-score range 0-100)

**Measure:** For females: compare patient-reported lubrication and vaginal comfort (PROMIS Sexual Function and Satisfaction Measure - lubrication and vaginal comfort domains) between the study groups

**Time Frame:** 8 and 12 weeks

**Description:** 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)

**Measure:** Compare patient reported quality of life (FACT-BMT) between the study groups

**Time Frame:** 8 and 12 weeks

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

**Measure:** Compare patient reported depression symptoms (HADS-depression) between the two study groups

**Time Frame:** 8 and 12 weeks

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

**Measure:** Compare patient reported anxiety symptoms (HADS-anxiety) between the two study groups

**Time Frame:** 8 and 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients (≥18 years) who underwent an autologous or allogeneic HCT at least 3 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 NCCN survivorship guidelines

Exclusion Criteria:

* Recurrent disease requiring treatment
* Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital Cancer Center

**State:** Massachusetts

**Zip:** 02114

#### Overall Officials

**Official 1:**

**Affiliation:** Massachusetts General Hospital

**Name:** Areej El-Jawahri, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

**Description:** The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** Data can be shared no earlier than 1 year following the date of publication

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2024-01-01

- Date Unknown: Unknown

#### Event: RESET

- Date: 2024-01-22

- Date Unknown: Unknown

## Derived Section

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-01-01

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2024-01-01

- Reset Date: 2024-01-22

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- MCP Release N: Unknown

- Release Date: 2024-02-06

- Reset Date: Unknown

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
