Clinical trial NCT06541002: A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Official title: Multi-Site Randomized Controlled Trial of a Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Dysfunction
Stem Cell Transplant Complications
Bone Marrow Transplant Complications
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-08-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: Week 8
Secondary outcomes:
measure: Global satisfaction with sex (longitudinally) as measured by the global satisfaction with sex domain from the PROMIS Satisfaction with Sex Life scale
timeFrame: Up to week-24
measure: Sexual interest as measured by the interest in sexual activity domain from the PROMIS Sexual Function and Satisfaction scale
timeFrame: Up to week-24
measure: Sexual function (orgasm) as measured by the by the Orgasm - Pleasure domain from the PROMIS Sexual Function and Satisfaction scale
timeFrame: Up to week-24
measure: Sexual function (vaginal discomfort, and vaginal lubrication) as measured by the Female Sexual Function Index scale
timeFrame: Up to week-24
measure: Erectile function as measured by the International Index of Erectile Function scale
timeFrame: Up to week-24
measure: Quality of Life as measured by the Functional Assessment of Cancer Therapy- Bone Marrow Transplant scale
timeFrame: Up to week-24
measure: Anxiety symptoms as measured by the Hospital Anxiety and Depression Scale
timeFrame: Up to week-24
measure: Depression symptoms as measured by the Hospital Anxiety and Depression Scale
timeFrame: Up to week-24
Other outcomes:
measure: The proportion of participants who are sexually active using the PROMIS Sexual Activity Screener
timeFrame: Up to week-24
measure: Emotional and sexual intimacy as measured by the emotional and sexual intimacy subscales in Personal Assessment of Intimacy in Relationship scale
timeFrame: Up to week-24
measure: To compare participants' self-efficacy for discussing sexual health with their transplant clinicians using the Self-Efficacy Questionnaire
timeFrame: Up to week-24
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: