Clinical trial · Interventional
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
NCT03528863CI-TRIAL-00047589completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Caregiver | — | UNRESOLVED | — |
| Metastatic Gastrointestinal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online Mindfulness Meditation | Behavioral | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (web-based mindfulness meditation)
- description
- 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.
- interventionNames
- Behavioral: Online Mindfulness Meditation
- Other: Questionnaire Administration
Primary outcomes (7)
- measure
- Feasibility as assessed by evaluating recruitment rate
- timeFrame
- At end of enrollment (Up to 1 year)
- description
- Number of participants approached who consent to participate
- measure
- Feasibility as assessed by evaluating rate of refusal to participate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDragomanovich HM, Dhruva A, Ekman E, Schoenbeck KL, Kubo A, Van Blarigan EL, Borno HT, Esquivel M, Chee B, Campanella M, Philip EJ, Rettger JP, Rosenthal B, Van Loon K, Venook AP, Boscardin C, Moran P, Hecht FM, Atreya CE. Being Present 2.0: Online Mindfulness-Based Program for Metastatic Gastrointestinal Cancer Patients and Caregivers. Glob Adv Health Med. 2021 Nov 3;10:21649561211044693. doi: 10.1177/21649561211044693. eCollection 2021. PMID 35174001