Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Other Cancer Clinical Trial

Official title:

Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03967379
• Other study ID #: 19-104
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.

Description:

Frequently survivors of stem cell transplantation report significant problems with their sexual function that impacts their quality of life, mood, and their intimacy and relationship with their partners. These issues can be very distressing to patients and their loved ones. The study doctors want to know if the use of a mobile app intervention focused on improving sexual function may improve participants overall care.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (=18 years) who underwent an autologous or allogeneic HCT at least 3 months prior to study enrollment.

• Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member.

• Positive screen for sexual dysfunction that is causing distress based on the NCCN survivorship guidelines

Exclusion Criteria:

• Recurrent disease requiring treatment

• Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.

Related Conditions & MeSH terms

• Other Cancer

Intervention

Behavioral:
• Mobile App + enhanced standard care
An intervention to help address sexual dysfunction among HCT survivors

Other:
• Enhanced Standard Care
Standard of care administered by the institution

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of the intervention	feasibility will be defined if at least 60% of eligible patients enroll and engage with at least 70% of the intervention modules	2 years
Secondary	Compare patient-reported global satisfaction with sex (PROMIS Sexual Function and Satisfaction Measure) between the study groups	patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (there is a raw and T score. T score range 0-100)	8 and 12 weeks
Secondary	Compare patient-reported interest in sexual activity (PROMIS Sexual Function and Satisfaction Measure - Interest in sexual activity domain) between the study groups	compare patient-reported interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain). higher score indicate better interest in sex (there is a raw and T score, T score range 0-100)	8 and 12 weeks
Secondary	Compare patient-reported orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) between the study groups	compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (there is a raw and t-score, t-score range 0-100)	8 and 12 weeks
Secondary	For males: compare patient-reported erectile function (PROMIS Sexual Function and Satisfaction Measure - Erectile function domain) between the study groups	for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (there is a raw and t-score, T-score range 0-100)	8 and 12 weeks
Secondary	For females: compare patient-reported lubrication and vaginal comfort (PROMIS Sexual Function and Satisfaction Measure - lubrication and vaginal comfort domains) between the study groups	For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain). higher score indicate better lubrication and vagina comfort (there is a raw and T-score, T-score range 0-100)	8 and 12 weeks
Secondary	Compare patient reported quality of life (FACT-BMT) between the study groups	compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). higher score indicate better quality of life (range 0-196)	8 and 12 weeks
Secondary	Compare patient reported depression symptoms (HADS-depression) between the two study groups	compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21)	8 and 12 weeks
Secondary	Compare patient reported anxiety symptoms (HADS-anxiety) between the two study groups	compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21)	8 and 12 weeks