- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03967379
Multimodal mobilinterventionsapplikation (app) til behandling af seksuel dysfunktion hos hæmatopoietiske stamcelletransplanterede overlevende
This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Mobile app plus enhanced standard care
|
An intervention to help address sexual dysfunction among HCT survivors Standard of care administered by the institution |
|
Andet: Enhanced Standard Care
|
Standard of care administered by the institution |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility Based on Proportion of Subjects Enrolled
Tidsramme: 2 years
|
feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study. |
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups
Tidsramme: 8 weeks
|
patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (raw score range 4-25). We will use raw score for reporting in this study given the extent of illness in this population. |
8 weeks
|
|
Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups
Tidsramme: 8 weeks
|
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 (raw score range 2-10). |
8 weeks
|
|
Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups
Tidsramme: 8 weeks
|
compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (raw score range 3-15). |
8 weeks
|
|
For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups
Tidsramme: 8 weeks
|
for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (raw score range 0-55) |
8 weeks
|
|
For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups
Tidsramme: 8 weeks
|
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 (raw score 0-25) |
8 weeks
|
|
Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups
Tidsramme: 8 weeks
|
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 weeks
|
|
Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups
Tidsramme: 8 weeks
|
compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21) |
8 weeks
|
|
Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups
Tidsramme: 8 weeks
|
compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21) |
8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Areej El-Jawahri, MD, Massachusetts General Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 19-104
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD-delingstidsramme
Data can be shared no earlier than 1 year following the date of publication
IPD-delingsadgangskriterier
BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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