- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03345264
The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study (PATHS)
Concerns with sexual health and fertility are common among cancer patients, survivors and their partners. Literature reviews suggest that over 60% of survivors have reproductive health problems yet fewer than 20% get professional help. This study will test the uptake, use and effectiveness of online, interactive self-help programs for men and women with cancer. Participants in the study will receive up to 6 months of access to the self-help programs without charge. Navigation through the programs can be personalized by setting goals and following links to the most relevant information. The programs cover all cancer sites and common treatments, explaining sexual and fertility side effects. Programs also include step-by-step cognitive behavioral self-help exercises, guidance on available medical treatment options, decision aids, and video stories with actual survivors as well as vignettes with actors. Information for same-sex couples is included. Programs include suggestions on how partners can work together to cope with sexual or fertility issues.
The primary hypothesis is that participants will report improvements in sexual function and satisfaction from baseline to 3-month follow-up. Secondary hypotheses will investigate whether more extensive use of the program is associated with better outcomes (dose-response effect) and whether the intervention also improves secondary outcomes such as anxiety, depression, relationship satisfaction, and seeking medical help. Analyses from the data will investigate how many people who are informed of the study decide to participate (uptake), as well as how often participants visit the program and which parts are used most. Both the male and female programs have previously been shown to help cancer survivors and partners in published clinical trials.
Participants will be encouraged to invite a sexual partner to join the study, but that will be optional. Partners will be able to be linked for statistical analysis through their unique study identification numbers. Participants' use of the websites will be electronically tracked and compared with questionnaire outcome measures. Outcome measures include online, self-report questionnaires completed at baseline and 3-month follow-up. At 6-month follow-up, participants will complete 2 online ratings of the helpfulness of the programs. Privacy and security are carefully protected. The entire website meets standards for HIPAA (Health Insurance Portability and Accountability Act). Questionnaires are identified with study numbers rather than names or email addresses. Once the study data are analyzed, the list linking participant identifying information (names, email) and study numbers will be destroyed. Any publications resulting from the study will discuss group data and will not contain any information that could be used to identify an individual participant.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Texas
-
Houston, Texas, États-Unis, 77025
- Will2Love, LLC
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Has had a diagnosis of cancer or is the intimate partner of a cancer patient/survivor
- Has a concern or wants to learn more about cancer-related issues with sexuality or fertility
- Has a way to access the website and questionnaires on the internet
Exclusion Criteria:
- Younger than age 18
- Does not read and understand English well enough to use the website independently
- Does not live in the United States
- Potential participant has already subscribed to the male or female self-help program
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Cancer patients, survivors, and partners
|
Participants will receive access to the program, which provides: In-depth information specific to cancer sites and treatments, guidance on medical options for cancer-related sex or fertility problems, personalized goal-setting with progress tracking and relapse prevention, self-help exercises on overcoming sexual, relationship, and dating problems, videos of survivors' stories, and video vignettes with actors.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Male
Délai: Change from baseline to 3 months post consent
|
Construct: Sexual function and satisfaction in men; Total Score Range: 0-33; Higher values represent a better outcome
|
Change from baseline to 3 months post consent
|
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Female
Délai: Change from baseline to 3 months post consent
|
Construct: Sexual function and satisfaction in women; Total Score Range: 0-49; Higher values represent a better outcome
|
Change from baseline to 3 months post consent
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Anxiety Scale
Délai: Change from baseline to 3 months post consent
|
Construct: General anxiety level; Total Score Range: 0-16; Higher scores represent a worse outcome
|
Change from baseline to 3 months post consent
|
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Depression Scale
Délai: Change from baseline to 3 months post consent
|
Construct: Depressed Mood; Total Score Range: 0-16; Higher scores represent a worse outcome
|
Change from baseline to 3 months post consent
|
Abbreviated Dyadic Adjustment Scale-4
Délai: Change from baseline to 3 months post consent
|
Construct: Relationship happiness; Total Score Range: 0-21; Higher scores represent a better outcome
|
Change from baseline to 3 months post consent
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Tenbroeck Smith, American Cancer Society, Inc.
- Chercheur principal: Leslie Schover, Will2Love, LLC
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PATHS IRB1094101
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Online, interactive self-help program
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)Complété
-
Hospices Civils de LyonRésilié
-
University of SheffieldComplétéBrûlures | Condition de la peau | Différence visible | Thérapie d'acceptation et d'engagement | LOI | État des cheveux | CraniofacialRoyaume-Uni
-
Kaiser PermanenteOregon Health and Science UniversityComplétéLa dépressionÉtats-Unis