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

Trial Summary

What is the purpose of this trial?

This research study is evaluating the efficacy of a novel self-administered digital application for improving sexual health outcomes, quality of life, and psychological distress in hematopoietic stem cell transplant survivors.

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 data supports the effectiveness of the treatment SHIFT for stem cell transplant survivors?

Research on similar mobile health apps for stem cell transplant patients shows that these apps can help track symptoms and improve patient outcomes by allowing earlier detection of issues and better management of health. For example, the TRU-BMT app showed that greater adherence was linked to better health outcomes like increased meal completion and shorter hospital stays. ^{1 2 3 4 5}

Is the digital app for stem cell transplant survivors safe to use?

The digital app for stem cell transplant survivors has been tested in small studies and found to be feasible and well-received by patients and healthcare professionals, with no specific safety concerns reported. However, more research is needed to fully understand its long-term safety and effectiveness. ^{1 2 3 6 7}

How does the SHIFT treatment differ from other treatments for stem cell transplant survivors?

The SHIFT treatment is unique because it involves a digital app designed to help stem cell transplant survivors by tracking their symptoms and health daily, potentially allowing for earlier detection of complications and improving outcomes. Unlike traditional treatments, this app-based approach offers a novel way to monitor patients' health remotely and continuously. ^{1 2 3 6 8}

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. [2023]

2. United States 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. [2023]

3. Canada 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. [2021]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Consistency and construct validity of the Activity Card Sort (modified) in measuring activity resumption after stem cell transplantation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

eHealth-Generated Patient Data in an Outpatient Setting after Hematopoietic Stem Cell Transplantation: A Scoping Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Survivor and Clinician Assessment of Survivorship Care Plans for Hematopoietic Stem Cell Transplantation Patients: An Engineering, Primary Care, and Oncology Collaborative for Survivorship Health. [2020]

8. Canada 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. [2020]