A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (> 18 years) who underwent autologous or allogeneic HCT > three months prior to study enrollment
Screen positive for sexual health concerns causing distress based on the National Comprehensive Network (NCCN) survivorship guidelines screening questions
Disqualifiers
Patients who do not comprehend English or Spanish since SHIFT will only be available in these two languages for this efficacy trial.
Patients with any major uncontrolled psychiatric disorder or other comorbid cognitive conditions, which the treating HCT clinician believes would prohibit the patients' capacity to provide informed consent and participate in study procedures.
Patients with relapsed disease requiring treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
SHIFT Intervention Group
BehavioralParticipants 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.
Enhanced Usual Care Group
BehavioralParticipants 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: SHIFT Intervention GroupExperimental treatment 1 intervention
Group B: Enhanced Usual Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 8Secondary outcomes
1
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.
Time frame
Up to week-242
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.
Time frame
Up to week-243
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.
Time frame
Up to week-244
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.
Time frame
Up to week-24Other outcomes
1
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.
Time frame
Up to week-242
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.
Time frame
Up to week-243
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.
Time frame
Up to week-24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov