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- Klinische proef NCT03967379
Multimodale mobiele interventie-applicatie (app) om seksuele disfunctie aan te pakken bij overlevenden van hematopoëtische stamceltransplantaties
This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital Cancer Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Mobile app plus enhanced standard care
|
An intervention to help address sexual dysfunction among HCT survivors Standard of care administered by the institution |
|
Ander: Enhanced Standard Care
|
Standard of care administered by the institution |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility Based on Proportion of Subjects Enrolled
Tijdsspanne: 2 years
|
feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study. |
2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Areej El-Jawahri, MD, Massachusetts General Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 19-104
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
Data can be shared no earlier than 1 year following the date of publication
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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