Digital App for Stem Cell Transplant Survivors

(SHIFT Trial)

Recruiting at 2 trial locations

Overseen By Sajeewani Samarakoon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Uncontrolled psychiatric, Cognitive conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital app called SHIFT to determine its effectiveness in improving sexual health, enhancing quality of life, and reducing stress in individuals who have undergone a stem cell transplant. The app features engaging activities such as gamification, videos, and intimacy exercises. Participants will be divided into two groups: one using the app and the other receiving standard care. This trial suits those who had a stem cell transplant over three months ago and are experiencing distressing sexual health issues. Participants must understand English or Spanish to take part. As an unphased trial, this study provides a unique opportunity to explore innovative digital solutions for enhancing well-being after a stem cell transplant.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital application is safe for hematopoietic stem cell transplant survivors?

Research shows that the SHIFT app helps stem cell transplant survivors with sexual health, quality of life, and emotional well-being. Studies have found that survivors can use it easily and that it may improve sexual health.

As a digital tool, the SHIFT app is safe because it doesn't involve medication or medical procedures. Users simply interact with the app on their devices. Patients and health professionals contributed to its creation to ensure it meets users' needs effectively and safely.

Overall, no safety concerns have been reported with the SHIFT app, making it a low-risk option for those interested in this type of digital health support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SHIFT app for stem cell transplant survivors because it offers a unique, interactive approach to post-transplant care. Unlike standard follow-up treatments that mainly involve regular clinician visits, SHIFT is a self-administered digital app designed to engage users through gamification, survivor videos, and intimacy exercises. This innovative method not only encourages health behavior changes but also empowers patients with a sense of control over their recovery process, potentially leading to better long-term outcomes.

What evidence suggests that this digital app is effective for improving sexual health outcomes in stem cell transplant survivors?

Research has shown that the SHIFT digital app, which participants in this trial may receive, can help improve sexual health and overall quality of life for those who have undergone a stem cell transplant. In early studies, users of the SHIFT app experienced better sexual health and reduced psychological distress. The app engages users with fun features and personal stories from other transplant survivors to encourage positive changes. These early results suggest that the SHIFT app could be a valuable tool for enhancing health after a stem cell transplant. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone a hematopoietic stem cell transplant and are experiencing sexual dysfunction or complications from the procedure. Participants should be interested in using a digital application to improve their sexual health, quality of life, and psychological well-being.

Inclusion Criteria

Screen positive for sexual health concerns causing distress based on the National Comprehensive Network (NCCN) survivorship guidelines screening questions

I had a stem cell transplant more than three months ago.

Exclusion Criteria

I do not have any severe mental health issues that would prevent me from understanding and consenting to the study.

I understand either English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SHIFT digital application to improve sexual health outcomes, quality of life, and psychological distress

8 weeks

Self-administered, no in-person visits required

Follow-up

Participants are monitored for quality of life, sexual satisfaction, and psychological outcomes

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SHIFT

Trial Overview The study is testing a new self-help digital app called SHIFT designed to help stem cell transplant survivors with their sexual health. It compares outcomes between those using SHIFT and those receiving enhanced usual care without the app.

How Is the Trial Designed?

Group I: SHIFT Intervention Group Experimental Treatment 1 Intervention

SHIFT is a self-administered, multi-component digital application for HCT survivors, incorporating several features to promote engagement and health behavior change, and includes gamification strategies, videos of HCT survivors, intimacy exercises, and optional content.

Group II: Enhanced Usual Care Group Active Control 1 Intervention

Patients assigned to enhanced usual care group will not receive access to the SHIFT application. They will meet with their HCT clinician and maybe referred to specialist care at the patients' request or at the discretion of the HCT clinician.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The TRU-BMT mHealth app was developed to help hematopoietic stem cell transplantation (HCT) patients monitor their health daily, aiming to improve symptom tracking and early detection of complications, with a pilot study involving 30 patients over 180 days.

Adherence to the app was around 30% daily and 44% weekly, and higher adherence correlated with better health outcomes, such as increased meal completion and shorter hospital stays, indicating the app's potential to enhance patient management during HCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. Racioppi, A., Dalton, T., Ramalingam, S., et al.[2023]

A new intervention module was developed to improve medication adherence for patients undergoing allogeneic stem cell transplantation, focusing on the implementation and persistence phases of adherence using a structured approach based on behavior change theories.

The intervention identified key behaviors and barriers related to immunosuppressant use, and selected specific strategies like education and goal setting to enhance adherence, which could serve as a model for future eHealth solutions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theory-driven development of a medication adherence intervention delivered by eHealth and transplant team in allogeneic stem cell transplantation: the SMILe implementation science project. Ribaut, J., Leppla, L., Teynor, A., et al.[2021]

The INTERACCT mobile app significantly improved the quality of self-reported medical data in adolescent HSCT patients compared to traditional paper diaries, with a score of 4.14 versus 3.77 (P=.02).

Adolescents, especially those with treatment-related complications, used the app longer and reported higher satisfaction, indicating that the app is a promising tool for enhancing patient compliance and communication in long-term cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Mobile App (INTERACCT App) for Adolescents Undergoing Cancer and Hematopoietic Stem Cell Transplantation Aftercare to Improve the Quality of Medical Information for Clinicians: Observational Study. Lawitschka, A., Buehrer, S., Bauer, D., et al.[2021]

The MY-Medula mHealth platform was successfully implemented in a pilot study with 28 allogeneic stem cell transplantation (allo-SCT) recipients, showing high usability with a median of 143 app visits per patient over 2 months.

Patients and healthcare professionals reported high satisfaction rates (95% and 100%, respectively) with the integrated care model, indicating that mHealth tools can enhance follow-up care for allo-SCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study. Redondo, S., De Dios, A., Gomis-Pastor, M., et al.[2023]

A qualitative study involving 10 adult caregivers of patients who underwent hematopoietic stem cell transplantation (HSCT) was conducted to refine the survey for the Roadmap 2.0 mobile health app, highlighting the importance of user feedback in app development.

Cognitive interviews revealed areas for improvement in the survey design, such as clarifying transplant types and care contexts, which will enhance the app's effectiveness in supporting caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a National Caregiver Health Survey for Hematopoietic Stem Cell Transplant: Qualitative Study of Cognitive Interviews and Verbal Probing. Kedroske, J., Koblick, S., Chaar, D., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06541002?draw=2&rank=1

A Novel Digital Application (SHIFT) to Improve Outcomes ... SHIFT is a self-administered, multi-component digital application for HCT survivors, incorporating several features to promote engagement and health behavior ...

2. astctjournal.org astctjournal.org/article/S2666-6367(24)00605-5/fulltext

Design and Development of a Multimodal Digital ... We describe a five-step process involving diverse stakeholders for developing a digital health intervention (SHIFT) to address sexual dysfunction in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39938468/

A Digital Intervention to Address Sexual Health in ... The SHIFT digital app to address sexual dysfunction demonstrated feasibility and promising preliminary efficacy in improving sexual health outcomes, QoL, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666636724006055

Design and Development of a Multimodal Digital ... SHIFT is novel, patient-centered digital application to address sexual dysfunction in HSCT survivors. Iterative feedback from key stakeholders including HSCT ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/524743

A Novel Digital Application (SHIFT) to Improve Outcomes for ... SHIFT is a self-administered, multi-component digital application for HCT survivors, incorporating several features to promote engagement and health behavior ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06541002

Study Details | NCT06541002 | A Novel Digital Application ... SHIFT is a self-administered, multi-component digital application for HCT survivors, incorporating several features to promote engagement and health behavior ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39181537/

Design and Development of a Multimodal Digital Intervention ... SHIFT is novel, patient-centered digital application to address sexual dysfunction in HSCT survivors. Iterative feedback from key stakeholders including HSCT ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123117435

Multimodal Mobile Application to Address Sexual ... A multimodal mobile app to address sexual dysfunction is feasible to use for HCT survivors and has promising preliminary efficacy for improving sexual health ...

9. trialx.com trialx.com/clinical-trials/listings/298838/a-novel-digital-application-shift-to-improve-outcomes-for-hematopoietic-stem-cell-transplant-survivors/

Stem Cell Transplant Complications This multi-site randomized trial will test the efficacy SHIFT for improving sexual health outcomes, quality of life, and psychological distress ...