- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03528863
Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers
Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
California
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San Francisco, California, Vereinigte Staaten, 94115
- University of California, San Francisco
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Nebenstudien
Receive web-based mindfulness meditation
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Feasibility as assessed by evaluating recruitment rate
Zeitfenster: At end of enrollment (Up to 1 year)
|
Number of participants approached who consent to participate
|
At end of enrollment (Up to 1 year)
|
Feasibility as assessed by evaluating rate of refusal to participate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Acceptability as assessed by adherence to practice instructions
Zeitfenster: At 8 weeks after study start (Up to 1 year)
|
Number of times participant watches recorded webinars, documented via website data capture
|
At 8 weeks after study start (Up to 1 year)
|
Acceptability as assessed by adherence to practice instructions
Zeitfenster: At 8 weeks after study start (Up to 1 year)
|
Number of times patient participates in live webinars, documented via roll-call.
|
At 8 weeks after study start (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
Zeitfenster: 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)
Zeitfenster: 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 Five Facet Mindfulness Questionnaire Short (FFMQ-SF)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Chloe Atreya, MD, University of California, San Francisco
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 174534 (Integrated Research Application System)
- NCI-2018-00622 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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