A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
NCT Number: NCT06541002
Acronym: SHIFT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sexual Dysfunction|Stem Cell Transplant Complications|Bone Marrow Transplant Complications
Interventions: BEHAVIORAL: SHIFT Intervention Group|BEHAVIORAL: Enhanced Usual Care Group
Sponsor: Massachusetts General Hospital
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01-01
Completion Date: 2030-04-30
Locations: University of Miami, Coral Gables, Florida, 33124, United States|Massachusetts General Hospital (MGH), Boston, Massachusetts, 02114, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States

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.

Primary Outcome Measures: Global satisfaction with sex at week 8 as measured by the global satisfaction with sex domain from the Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Sex Life scale., 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., Week 8
Secondary Outcome Measures: Global satisfaction with sex (longitudinally) as measured by the global satisfaction with sex domain from the PROMIS Satisfaction with Sex Life scale, 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., Up to week-24|Sexual interest as measured by the interest in sexual activity domain from the PROMIS Sexual Function and Satisfaction scale, 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., Up to week-24|Sexual function (orgasm) as measured by the by the Orgasm - Pleasure domain from the PROMIS Sexual Function and Satisfaction scale, 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., Up to week-24|Sexual function (vaginal discomfort, and vaginal lubrication) as measured by the Female Sexual Function Index scale, 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., Up to week-24|Erectile function as measured by the International Index of Erectile Function scale, 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., Up to week-24|Quality of Life as measured by the Functional Assessment of Cancer Therapy- Bone Marrow Transplant scale, 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., Up to week-24|Anxiety symptoms as measured by the Hospital Anxiety and Depression Scale, 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)., Up to week-24|Depression symptoms as measured by the Hospital Anxiety and Depression Scale, 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)., Up to week-24
Other Outcome Measures: The proportion of participants who are sexually active using the PROMIS Sexual Activity Screener, 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., Up to week-24|Emotional and sexual intimacy as measured by the emotional and sexual intimacy subscales in Personal Assessment of Intimacy in Relationship scale, 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., Up to week-24|To compare participants' self-efficacy for discussing sexual health with their transplant clinicians using the Self-Efficacy Questionnaire, 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., Up to week-24