Empowered Relief® for Cancer Survivors With Chronic Pain
Feasibility and Preliminary Efficacy of Empowered Relief® for Cancer Survivors With Chronic Pain
This randomized controlled study to examine the efficacy of ER class in cancer survivors with chronic pain. Eligible participants will be randomly assigned to a ER class or a waitlist control condition. We will recruit 250 participants with a goal of having 200 completers (20% attrition). Participants in the control condition will be invited to attend ER class after the 3-month observation period.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The Empowered Relief (ER) study is a Zoom-based, 1-session, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily use and supportive daily text messages. Participants will fill out a series of follow-up surveys at the 1, 2, and 3-month post-class mark. These surveys will be directly compared to surveys given to participants that do not complete the course. Class admittance will be randomized, however, participants not in the treatment group will have the option to take the course after the 3-month observatory period. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety. Because of its brief, didactic nature and delivery via Zoom, ER can accommodate large class sizes and may address access disparities among underserved cancer survivors. ER is currently being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad. Yet, Empowered Relief has not been tested in cancer survivors.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sophia You, PhD, ABPP
- Numéro de téléphone: 918-660-3923
- E-mail: Dokyoung-You@ou.edu
Sauvegarde des contacts de l'étude
- Nom: Jordan Keast, BS
- E-mail: jordan-keast@ou.edu
Lieux d'étude
-
-
Oklahoma
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Tulsa, Oklahoma, États-Unis, 74135
- Recrutement
- University of Oklahoma Schusterman Center - Tulsa
-
Contact:
- Jordan Keast, BS
- E-mail: jordan-keast@ou.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
History of cancer diagnosis, completion of active cancer treatment, cancer free at the time of enrollment, experience of body pain most or every day, pain duration at least 3 months, and English fluency.
Exclusion Criteria:
Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the zoom-based ER class). Life-threatening acute illness (e.g., infection, heart attack, injury), and no access to a computer, a smartphone or a tablet.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Empowered Relief
Participants in this arm of the study will complete the one-time 2hr Empowered Relief zoom course. They will also complete a post-course survey as well as the standardized 1, 2, and 3-month follow-up surveys. |
This is a one-time 2 hour long skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily use and supportive daily text messages. |
|
Aucune intervention: Wait-List Control
Participants in the Wait-List Control (WLC) arm will not have initial access to the empowered relief course. Additionally they will not have to complete a post-course survey. The WLC group will be asked to complete the 1, 2, and 3-month follow-up studies after no intervention. After this 3-month observatory period, WLC participants will have voluntary access to the Empowered Relief course. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall treatment satisfaction
Délai: Immediately after intervention
|
0-10 scale, higher scores indicate greater satisfaction, mean should be 8 or higher |
Immediately after intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain Intensity
Délai: 1 month after intervention
|
0-10 scale, higher scores indicate higher pain |
1 month after intervention
|
|
Pain Interference
Délai: 1 month after intervention
|
T-scores, higher scores indicate higher pain interference |
1 month after intervention
|
|
Pain Intensity
Délai: 3 months after intervention
|
0-10 Scale, higher scores indicate higher pain |
3 months after intervention
|
|
Pain Interference
Délai: 3 months after intervention
|
T-scores, higher scores indicate higher pain interference |
3 months after intervention
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sophia You, PhD, ABPP, University of Oklahoma
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 18957P
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
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