NCT Number: NCT06541002
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of Miami, Coral Gables, Florida, United States
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 individual's 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants assigned to SHIFT will meet with their HCT clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or genital graft-versus-host disease; and start using SHIFT at their desired pace over 8 weeks to complete five modules.
Participants assigned to the enhanced usual care group will meet with their HCT clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or genital graft-versus-host disease; and maybe referred to a psychologist, urologist, or gynecologist at the participants' request or at the discretion of the HCT clinician.
Time frame: Week 8
To compare patient global satisfaction with sex scores at week 8 after enrollment between those receiving SHIFT versus enhanced usual care as measured by the PROMIS global satisfaction with sex domain from the PROMIS Scale v2.0 Satisfaction with Sex Life.
Higher scores indicate higher satisfaction with sex life, and lower scores indicate less satisfaction with sex life.
Time frame: Up to week-24
To compare patient global satisfaction with sex longitudinally between those receiving SHIFT versus enhanced usual care as measured by the global satisfaction with sex domain from the PROMIS Scale v2.0 Satisfaction with Sex Life scale.
Higher scores indicate higher satisfaction with sex life, and lower scores indicate less satisfaction with sex life.
Time frame: Up to week-24
To compare sexual interest both at week 8 and longitudinally after enrollment between those receiving SHIFT versus enhanced usual care as measured by the interest in sexual activity domain from the PROMIS Scale v2.0 Sexual Function and Satisfaction scale.
Higher scores indicate more interest, and lower scores indicate less interest.
Time frame: Up to week-24
To compare sexual function (orgasm) both at week 8 and longitudinally after enrollment between those receiving SHIFT versus enhanced usual care as measured by the Orgasm - Pleasure domain from the PROMIS Scale v2.0 - Sexual Function and Satisfaction scale.
Higher scores from the Orgasm - Pleasure domain from the PROMIS Scale - Sexual Function and Satisfaction indicate more pleasurable orgasms.
Time frame: Up to week-24
To compare sexual function (vaginal discomfort, and vaginal lubrication) both at week 8 and longitudinally after enrollment between those receiving SHIFT versus enhanced usual care as measured by the Female Sexual Function Index (FSFI) for female participants.
Higher scores of FSFI indicate greater levels of sexual functioning and lower scores indicate lower levels of sexual functioning.
Time frame: Up to week-24
To compare erectile function both at week 8 and longitudinally after enrollment between those receiving SHIFT versus enhanced usual care as measured by the International Index of Erectile Function (IIEF-5) for male participants.
Higher scores of IIEF-5 indicate greater levels of sexual functioning and lower scores indicate lower levels of sexual functioning.
Time frame: Up to week-24
To compare quality of life (QOL) both at week 8 and longitudinally after enrollment between those receiving SHIFT versus enhanced usual care as measured by the Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) scale.
Higher scores on FACT-BMT indicate better QOL.
Time frame: Up to week-24
To compare anxiety symptoms both at week 8 and longitudinally after enrollment between those receiving SHIFT versus enhanced usual care as measured by the Hospital Anxiety and Depression Scale (HADS) Anxiety subscale.
Lower scores on HADS anxiety subscale indicate less anxiety (score: 0-7-Normal, 8-10-Mild, 11-15-Moderate, 16-21-Severe).
Time frame: Up to week-24
To compare depression symptoms both at week 8 and longitudinally after enrollment between those receiving SHIFT versus enhanced usual care as measured by the Hospital Anxiety and Depression Scale (HADS) Depression subscale.
Lower scores on HADS depression subscale indicate absence of depression (score: 0-7-Normal, 8-10-Mild, 11-15-Moderate, 16-21-Severe).
Time frame: Up to week-24
To compare the proportion of participants who are sexually active between those receiving SHIFT versus enhanced usual care as measured by the PROMIS Sexual Function and Satisfaction (SexFS) Version 2.0: Screener.
Time frame: Up to week-24
To compare emotional and sexual intimacy between those receiving SHIFT versus enhanced usual care using the emotional and sexual intimacy subscales from the Personal Assessment of Intimacy in Relationship (PAIR) emotional and sexual intimacy subscales.
Lower scores indicate greater relationship intimacy, and higher scores indicate lower relationship intimacy.
Time frame: Up to week-24
To compare participants' self-efficacy for discussing their sexual health with their transplant clinician's between those receiving SHIFT versus enhanced usual care using the Self-Efficacy Questionnaire.
This will be assessed using two items with score ranging from 0-20. Higher scores indicate better self-efficacy, and lower scores indicate lesser self-efficacy.
Contact information is provided by the study sponsor or research team.
Areej El-Jawahri, MD
CONTACT
Sajeewani Samarakoon, PhD
CONTACT
Massachusetts General Hospital
Other
Multi-Site Randomized Controlled Trial of a Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Acronym: SHIFT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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