Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541002
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Novel Digital Application SHIFT to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi-Site Randomized Controlled Trial of a Novel Digital Application SHIFT to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIFT
Brief Summary:
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
Detailed Description:
Autologous and Allogeneic hematopoietic stem cell transplant HCT are potentially curative treatments for many patients with hematologic malignancies and benign hematologic conditions The use of HCT has increased over the last decade HCT survivors experience a substantial and drastic deterioration in their sexual function that persists for many years post-HCT Sexual dysfunction is the most common long-term complication in HCT survivors Sexual health problems have negative consequences on patients quality of life QOL and mood including the individuals identity and self-esteem fatigue relationship discord intimacy problems and distress The etiology of sexual dysfunction in HCT survivors is multi-factorial and can stem from biological interpersonal psychological and social factors Given the multi-factorial nature underlying sexual dysfunction in this population a multimodal approach is required to address them Clinicians lack sufficient training to address sexual health problems in HCT survivors HCT survivors report having little communication with their clinicians about sexual health HCT survivors would benefit from interventions to empower them to communicate with their clinicians about their sexual health
Despite the well-documented burden of sexual dysfunction in HCT survivors interventions tailored to address their unique sexual health concerns are lacking Given the multi-factorial nature of sexual health concerns in HCT survivors interventions must address these diverse needs and should therefore ideally be addressed by a multidisciplinary team of sexual health experts psychologists gynecologists and urologists Although a few transplant centers have a multidisciplinary sexual health clinic the lack of professionals trained in addressing sexual health concerns severely limits the dissemination of such a complex service model In addition HCT survivors often find it difficult to attend multiple clinic appointments and coordinate their care among various specialists Limited availability of sexual health clinicians also hinders the scalability and dissemination of sexual health interventions to address the needs of HCT survivors Digital health interventions can enhance access and broad dissemination of psychological and supportive care interventions and will enable patients to access the intervention in the privacy of their home given the sensitivity of the topic engage their partners with the content and avoid additional clinic visits A successful evidence-based sexual health intervention was adapted to a digital app for HCT survivors The active components of an in-person sexual health intervention for HCT survivors were leveraged to develop the self-administered digital application Sexual Health and Intimacy Following Transplant SHIFT to address the sexual health concerns of HCT survivors This multi-site randomized trial will test the efficacy SHIFT for improving sexual health outcomes quality of life and psychological distress in HCT survivors
Despite the well-documented burden of sexual dysfunction in HCT survivors interventions tailored to address their unique sexual health concerns are lacking Given the multi-factorial nature of sexual health concerns in HCT survivors interventions must address these diverse needs and should therefore ideally be addressed by a multidisciplinary team of sexual health experts psychologists gynecologists and urologists Although a few transplant centers have a multidisciplinary sexual health clinic the lack of professionals trained in addressing sexual health concerns severely limits the dissemination of such a complex service model In addition HCT survivors often find it difficult to attend multiple clinic appointments and coordinate their care among various specialists Limited availability of sexual health clinicians also hinders the scalability and dissemination of sexual health interventions to address the needs of HCT survivors Digital health interventions can enhance access and broad dissemination of psychological and supportive care interventions and will enable patients to access the intervention in the privacy of their home given the sensitivity of the topic engage their partners with the content and avoid additional clinic visits A successful evidence-based sexual health intervention was adapted to a digital app for HCT survivors The active components of an in-person sexual health intervention for HCT survivors were leveraged to develop the self-administered digital application Sexual Health and Intimacy Following Transplant SHIFT to address the sexual health concerns of HCT survivors This multi-site randomized trial will test the efficacy SHIFT for improving sexual health outcomes quality of life and psychological distress in HCT survivors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None