- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
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San Francisco, California, Forenede Stater, 94115
- University of California, San Francisco
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Hjælpestudier
Receive web-based mindfulness meditation
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Feasibility as assessed by evaluating recruitment rate
Tidsramme: 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
Tidsramme: At end of enrollment (Up to 1 year)
|
Number of participants refusing to consent.
|
At end of enrollment (Up to 1 year)
|
Feasibility as assessed by rate of attrition
Tidsramme: 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
Tidsramme: At 8 weeks after study start (Up to 1 year)
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At 8 weeks after study start (Up to 1 year)
|
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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Chloe Atreya, MD, University of California, San Francisco
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 174534 (Integrated Research Application System)
- NCI-2018-00622 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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