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Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers

8 oktober 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

68

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • San Francisco, California, Förenta staterna, 94115
        • University of California, San Francisco

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Enkätadministration
Sidostudier
Beteende: Online Mindfulness Meditation
Receive web-based mindfulness meditation
Andra namn:
  • Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness Meditation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility as assessed by evaluating recruitment rate
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Acceptability as assessed by adherence to practice instructions
Tidsram: At 8 weeks after study start (Up to 1 year)
Number of times participant practices during study, documented via website data capture
At 8 weeks after study start (Up to 1 year)
Acceptability as assessed by adherence to practice instructions
Tidsram: 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
Tidsram: 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)
Acceptability as assessed by adherence to practice instructions
Tidsram: At 8 weeks after study start (Up to 1 year)
Average duration of meditation session (measured in minutes), documented via website data capture.
At 8 weeks after study start (Up to 1 year)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
Tidsram: At baseline, week 4 and week 8 after study start (Up to 1 year)
0 to 10, with 10 being the worst level of distress
At baseline, week 4 and week 8 after study start (Up to 1 year)
Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)
Tidsram: 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)
Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)
Tidsram: 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)
Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, San Francisco

Samarbetspartners

Genentech, Inc.

Utredare

  • Huvudutredare: Chloe Atreya, MD, University of California, San Francisco

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 maj 2018

Primärt slutförande (Faktisk)

31 oktober 2019

Avslutad studie (Faktisk)

31 oktober 2019

Studieregistreringsdatum

Först inskickad

30 april 2018

Först inskickad som uppfyllde QC-kriterierna

16 maj 2018

Första postat (Faktisk)

18 maj 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 oktober 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 oktober 2020

Senast verifierad

1 oktober 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 174534 (Integrated Research Application System)
  • NCI-2018-00622 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))

Plan för individuella deltagardata (IPD)

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Nej

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