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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00622 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (web-based mindfulness meditation) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Mindfulness Meditation | Behavioral | Receive web-based mindfulness meditation |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as assessed by evaluating recruitment rate | 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 | Number of participants refusing to consent. | At end of enrollment (Up to 1 year) |
| Feasibility as assessed by rate of attrition | 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 | 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 | 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 | 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 | Average duration of meditation session (measured in minutes), documented via website data capture. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chloe Atreya, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35174001 | Derived | Dragomanovich 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. |
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| Questionnaire Administration | Other | Ancillary studies |
|
| At 8 weeks 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) | 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 | At baseline, week 4 and week 8 after study start (Up to 1 year) |