Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers
8 octobre 2020 mis à jour par: University of California, San Francisco
Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers
This trial studies how well web-based mindfulness meditation works in reducing distress in both participants with gastrointestinal cancer that has spread to other parts of the body, and their caregivers.
Web-based mindfulness meditation, which uses audio exercises and interactive webinars taught by trained meditation instructors, may help participants with GI cancer and their caregivers reduce distress and improve their quality of life.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. To determine the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic gastrointestinal (GI) cancer receiving chemotherapy and their caregivers.
SECONDARY OBJECTIVES:
I. Estimate the efficacy of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic GI cancer receiving chemotherapy and their caregivers.
OUTLINE:
Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks. Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.
After completion of study, participants are followed up at 8 weeks.
Type d'étude
Interventionnel
Inscription (Réel)
68
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
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San Francisco, California, États-Unis, 94115
- University of California, San Francisco
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- ELIGIBLE PATIENTS: Carry a diagnosis of a metastatic GI cancer
- ELIGIBLE PATIENTS: Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
- ELIGIBLE PATIENTS: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
- ELIGIBLE PATIENTS: Have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
- ELIGIBLE PATIENTS: Be able to speak and read English
- ELIGIBLE PATIENTS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- ELIGIBLE PATIENTS: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
- ELIGIBLE PATIENTS: Be able to provide informed consent
- ELIGIBLE CAREGIVERS: Be a spouse/partner, other family member, or a close friend of a patient who consented to participate in the Being Present 2.0 study
- ELIGIBLE CAREGIVERS: Be able to speak and read English
- ELIGIBLE CAREGIVERS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- ELIGIBLE CAREGIVERS: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
- ELIGIBLE CAREGIVERS: Be able to provide informed consent
Exclusion Criteria:
- Have a current meditation practice (> 2 episodes or > 1 hour total, weekly)
- Be currently enrolled in a stress reduction program
- Have extensive hearing loss such that ability to participate in the study would be impaired
- Have participated in the original Being Present pilot study (BP1)
- Be caregivers of patients who decline Being Present 2.0 (BP2) study participation
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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: Supportive Care (web-based mindfulness meditation)
Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks.
Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.
|
Etudes annexes
Receive web-based mindfulness meditation
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility as assessed by evaluating recruitment rate
Délai: At end of enrollment (Up to 1 year)
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Number of participants approached who consent to participate
|
At end of enrollment (Up to 1 year)
|
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Feasibility as assessed by evaluating rate of refusal to participate
Délai: At end of enrollment (Up to 1 year)
|
Number of participants refusing to consent.
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At end of enrollment (Up to 1 year)
|
|
Feasibility as assessed by rate of attrition
Délai: At 8 weeks post end of enrollment (Up to 1 year)
|
Number of participants dropping out after start of intervention for any reason.
|
At 8 weeks post end of enrollment (Up to 1 year)
|
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Acceptability as assessed by adherence to practice instructions
Délai: At 8 weeks after study start (Up to 1 year)
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Number of times participant practices during study, documented via website data capture
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At 8 weeks after study start (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
Délai: At 8 weeks after study start (Up to 1 year)
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Number of times participant watches recorded webinars, documented via website data capture
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At 8 weeks after study start (Up to 1 year)
|
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Acceptability as assessed by adherence to practice instructions
Délai: At 8 weeks after study start (Up to 1 year)
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Number of times patient participates in live webinars, documented via roll-call.
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At 8 weeks after study start (Up to 1 year)
|
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Acceptability as assessed by adherence to practice instructions
Délai: At 8 weeks after study start (Up to 1 year)
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Average duration of meditation session (measured in minutes), documented via website data capture.
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At 8 weeks after study start (Up to 1 year)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
Délai: At baseline, week 4 and week 8 after study start (Up to 1 year)
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0 to 10, with 10 being the worst level of distress
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)
Délai: At baseline, week 4 and week 8 after study start (Up to 1 year)
|
At baseline, week 4 and week 8 after study start (Up to 1 year)
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|
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Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)
Délai: At baseline, week 4 and week 8 after study start (Up to 1 year)
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe
Délai: At baseline, week 4 and week 8 after study start (Up to 1 year)
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Chloe Atreya, MD, University of California, San Francisco
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
7 mai 2018
Achèvement primaire (Réel)
31 octobre 2019
Achèvement de l'étude (Réel)
31 octobre 2019
Dates d'inscription aux études
Première soumission
30 avril 2018
Première soumission répondant aux critères de contrôle qualité
16 mai 2018
Première publication (Réel)
18 mai 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 octobre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 174534 (Integrated Research Application System)
- NCI-2018-00622 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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