SCThrive for Sickle Cell Anemia

(SC-Thrive Trial)

Recruiting at 3 trial locations

Overseen By Taylor Richardson, BA

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Chronic disease, Non-English, Cognitive disorder

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests SCThrive, a program designed to help young people with sickle cell disease (SCD) manage their condition more effectively. Researchers aim to determine if SCThrive can enhance self-care skills, improve daily life, and reduce emergency room visits. Participants will either use the SCThrive app and join virtual group sessions or receive standard care with educational texts. Adolescents and young adults with SCD who visit one of the participating clinics might be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Do I need to stop my current medications for the SCThrive trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on a behavioral intervention, so it's likely you can continue your usual medications, but please confirm with the study team.

What prior data suggests that this behavioral self-management intervention is safe for adolescents and young adults with sickle cell disease?

Research has shown that SCThrive helps young people with sickle cell disease manage their condition. Unlike medications, SCThrive focuses on improving skills and behaviors, avoiding direct side effects associated with drugs.

SCThrive includes virtual group sessions and a mobile app, making it generally safe. No reports of negative effects have emerged, as it doesn't involve drugs or physical treatments. Some participants might feel stressed or anxious about group activities, but this is common in any group setting and not specific to SCThrive.

Overall, SCThrive is well-received and aids participants in managing their condition better without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for sickle cell anemia, which often focus on medications like hydroxyurea to reduce pain and complications, SCThrive is a game-changer as it is a virtual, behavioral self-management intervention. This innovative approach combines an 8-week group-based program with a daily companion mobile app, empowering patients to manage their condition more effectively through behavioral strategies. Researchers are excited about SCThrive because it provides a holistic, accessible way to improve patients' quality of life and self-efficacy, potentially reducing reliance on medication and medical interventions.

What evidence suggests that SCThrive is effective for sickle cell disease?

Research shows that programs like SCThrive, which participants in this trial may receive, can boost confidence in young people with sickle cell disease (SCD) to manage their own health. Studies have found that participants appreciate SCThrive's mix of in-person and online sessions because it helps them learn important skills. The program aims to engage patients more in their health care. Better self-management has been linked to improved daily life and fewer emergency room visits. These early findings suggest that SCThrive may help young people with SCD manage their condition more effectively. ^{1 2 6 7 8}

Who Is on the Research Team?

Lori E. Crosby, PsyD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 13-21 with a confirmed diagnosis of sickle cell disease (SCD), who are patients at one of the participating SCD clinics. It's not specified what conditions exclude someone from participation.

Inclusion Criteria

I am a patient at a participating SCD Clinic.

I have been diagnosed with sickle cell disease.

I am between 13 and 21 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week virtual group intervention with the SCThrive app

8 weeks

Virtual sessions

Follow-up

Participants are monitored for maintenance of improvements in self-management behaviors and patient activation

3-4 months

What Are the Treatments Tested in This Trial?

Interventions

• SCThrive

Trial Overview The study tests SCThrive, an 8-week virtual group intervention with a mobile app, against standard care plus educational texts (SCHealthED). The goal is to see if SCThrive improves patient activation, self-management behaviors, daily functioning, and reduces emergency room visits.

How Is the Trial Designed?

Group I: Active Treatment Active Control 1 Intervention

SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.

Group II: Control Condition Placebo Group 1 Intervention

Participants randomized to SCHealthED will receive usual care plus 7 text messages consisting of SCD educational facts to ensure the care is uniform across sites.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Nemours Children's Health System

Collaborator

Trials

11

Recruited

17,400+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Research into drugs that can induce fetal hemoglobin (HbF) is crucial for treating sickle cell anemia (SCA), with a focus on understanding the mechanisms of β-globin regulation to design effective therapies.

Promising strategies include targeting gamma-globin regulation through epigenetic enzymes and exploring the guanylate cyclase and NO/cGMP signaling pathways, which may not only induce HbF but also provide cardiovascular protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of the art of fetal hemoglobin-inducing agents. Pavan, AR., Lopes, JR., Dos Santos, JL.[2023]

Neonatal screening (NS) for sickle cell disease (SCD) in Belgium has led to early detection and improved management, resulting in no deaths in the last 10 years despite the high morbidity associated with the disease.

Out of 96 children studied, 27% experienced no severe clinical events, while 39.6% had severe anemia, highlighting the need for comprehensive care, including prophylactic measures and treatments like hydroxyurea, to enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sickle cell disease from Africa to Belgium, from neonatal screening to clinical management. Lê, PQ., Ferster, A., Cotton, F., et al.[2022]

In a study of 78 children with sickle cell anemia (SCA) admitted over 58 months, 32.1% experienced musculoskeletal complications, highlighting a significant health concern in this population.

Acute osteomyelitis was identified as the most common complication, affecting 12.8% of the patients, indicating the need for careful monitoring and management of bone health in children with SCA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal complications among children with sickle cell admitted in university of Nigeria teaching hospital ituku - ozalla enugu: a 58 month review. Chinawa, J., Chukwu, B., Ikefuna, A., et al.[2021]

Pregnant women with sickle cell disease (SCD) experienced significantly higher rates of complications such as preterm delivery (5 times more likely) and cesarean sections (5 times more likely) compared to healthy pregnant women, based on a study of 60 pregnancies in SCD patients versus 192 in controls.

The SCD-SS subgroup had the most severe outcomes, including lower birth weights for babies (2080 g compared to 2737 g for SCD-SC and 3035 g for controls) and a higher prevalence of maternal complications, indicating that SCD significantly impacts both maternal and neonatal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy in patients with sickle cell disease: maternal and perinatal outcomes. Costa, VM., Viana, MB., Aguiar, RA.[2022]

Recent FDA-approved treatments for sickle cell disease (SCD), including L-Glutamine, Crizanlizumab, and Voxelotor, have demonstrated significant efficacy in reducing pain crises, hospitalizations, and improving hemolytic anemia.

These new therapies can be used alone or alongside hydroxyurea, providing patients with more options to manage their symptoms and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancements in Sickle Cell Disease (SCD) Treatment: A Review of Novel Pharmacotherapies and Their Impact on Patient Outcomes. Khan, SJ., Zaidi, SAT., Murtaza, SF., et al.[2023]

Citations

1. withpower.com withpower.com/trial/scthrive-for-sickle-cell-anemia-d2086

SCThrive for Sickle Cell Anemia (SC-Thrive Trial) The SCD-SS subgroup had the most severe outcomes, including lower birth weights for babies (2080 g compared to 2737 g for SCD-SC and 3035 g for controls) and a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7722105/

Improving Self-Management in Adolescents with Sickle ... The results support the potential for a self-management intervention to improve self-efficacy in AYA with SCD. Healthcare providers are encouraged to target BA ...

3. researchgate.net researchgate.net/publication/349725331_Perceptions_of_a_self-management_intervention_for_adolescents_with_sickle_cell_disease

Perceptions of a Self-Management Intervention for ... Results: SCThrive was reported to be highly feasible due to the mixed in-person/online format and acceptable because they learned skills to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10558056/

The Effectiveness of Common Interventions ... - PubMed Central It causes significant reduction in pain and vaso-occlusive crises, frequency of hospitalizations, need for blood transfusions, and other ...

5. pfizer.com pfizer.com/news/announcements/pfizer-provides-update-phase-3-inclacumab-study-treatment-people-sickle-cell

Pfizer Provides Update on Phase 3 Inclacumab Study for ... This release contains forward-looking information about inclacumab, an investigational P-selectin inhibitor, and Pfizer's other sickle cell ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04935879

NCT04935879 | A Study to Assess the Safety and Efficacy ... This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs)

7. sicklecellga.org sicklecellga.org/post/sickle-cell-advocates-affirm-support-for-drug-development-following-the-discontinuation-of-pfizer-s

Sickle Cell Advocates Affirm Support for Drug Development ... Sickle Cell Advocates Affirm Support for Drug Development Following the Discontinuation of Pfizer's THRIVE-131 Trial. mthomas075; Aug 15; 1 min ...

8. htct.com.br htct.com.br/en-trials-in-progress-the-thrive-articulo-resumen-S2531137922001614

TRIALS IN PROGRESS: THE THRIVE STUDIES ... The THRIVE-131 and THRIVE-132 phase 3 studies will examine the efficacy of inclacumab in reducing the frequency of VOCs and readmissions due to VOCs, and the ...