AzTrials
AzTrials

Other CancerNCT03967379

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

A study of Other Cancer, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Other Cancer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Feb 2019to 1 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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

Read the 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
Other Cancer
Being tested
Mobile App + enhanced standard care, Enhanced Standard Care
Keywords
Other Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile App + enhanced standard careBehavioural

    An intervention to help address sexual dysfunction among HCT survivors

  • Enhanced Standard CareOther

    Standard of care administered by the institution

Study groups in NCT03967379
Study groupRoleWhat they receive
Mobile app plus enhanced standard careExperimental* 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.
Receives: Behavioral: Mobile App + enhanced standard care; Other: Enhanced Standard Care
Enhanced Standard CareOther* 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
Receives: Other: Enhanced Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility Based on Proportion of Subjects Enrolled

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

    Measured: 2 years

Secondary outcomes (8)

  1. 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.

    Measured: 8 weeks

  2. 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).

    Measured: 8 weeks

  3. 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).

    Measured: 8 weeks

  4. 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)

    Measured: 8 weeks

  5. 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)

    Measured: 8 weeks

  6. 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)

    Measured: 8 weeks

  7. 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)

    Measured: 8 weeks

  8. 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)

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2019
  2. Study start1 Feb 2019
  3. Primary completion1 Jan 2023
  4. Study completion1 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03967379
Sponsor's protocol ID
19-104
Status last verified
Aug 2026
First submitted
27 May 2019
Last updated
24 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 40490014

Questions about this trial

What is this clinical trial studying?

A study of Other Cancer, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Based on Proportion of Subjects Enrolled (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03967379, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in