CaregiverNCT03528863
Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers
A study testing Online Mindfulness Meditation and Questionnaire Administration in people with Caregiver and Metastatic Gastrointestinal Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Metastatic Gastrointestinal Carcinoma
- What is being tested?
- Online Mindfulness Meditation and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Caregiver, Metastatic Gastrointestinal Carcinoma
- Being tested
- Online Mindfulness Meditation, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness MeditationBehavioural
Also called Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness Meditation
Receive web-based mindfulness meditation
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Mindfulness Meditation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by evaluating recruitment rate
Number of participants approached who consent to participate
Measured: At end of enrollment (Up to 1 year)
Feasibility as assessed by evaluating rate of refusal to participate
Number of participants refusing to consent.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At 8 weeks after study start (Up to 1 year)
Secondary outcomes (4)
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
0 to 10, with 10 being the worst level of distress
Measured: 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)
Measured: 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)
Measured: 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
Measured: At baseline, week 4 and week 8 after study start (Up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start7 May 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Chloe Atreya, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528863
- Sponsor's protocol ID
- 174534
- Other IDs
- NCI-2018-00622
- Status last verified
- Oct 2020
- First submitted
- 30 Apr 2018
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35174001
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers
- ClinicalTrials.gov ID
- NCT03528863
- Acronym / sponsor ID
- 174534
- Conditions
- Caregiver, Metastatic Gastrointestinal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (web-based mindfulness meditation) | Experimental | Behavioral: Online Mindfulness Meditation, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Mindfulness MeditationAlso: Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness MeditationReceive web-based mindfulness meditation | Behavioural | Supportive Care (web-based mindfulness meditation) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (web-based mindfulness meditation) |
Primary outcome
Feasibility as assessed by evaluating recruitment rate
Time frame: At end of enrollment (Up to 1 year)
Number of participants approached who consent to participate
Feasibility as assessed by evaluating rate of refusal to participate
Time frame: At end of enrollment (Up to 1 year)
Number of participants refusing to consent.
Feasibility as assessed by rate of attrition
Time frame: At 8 weeks post end of enrollment (Up to 1 year)
Number of participants dropping out after start of intervention for any reason.
Acceptability as assessed by adherence to practice instructions
Time frame: At 8 weeks after study start (Up to 1 year)
Number of times participant practices during study, documented via website data capture
Acceptability as assessed by adherence to practice instructions
Time frame: At 8 weeks after study start (Up to 1 year)
Number of times participant watches recorded webinars, documented via website data capture
Acceptability as assessed by adherence to practice instructions
Time frame: At 8 weeks after study start (Up to 1 year)
Number of times patient participates in live webinars, documented via roll-call.
Acceptability as assessed by adherence to practice instructions
Time frame: At 8 weeks after study start (Up to 1 year)
Average duration of meditation session (measured in minutes), documented via website data capture.
4 secondary outcomes
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Derived from this study: PubMed 35174001Dragomanovich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloe Atreya, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness Meditation and Questionnaire Administration in people with Caregiver and Metastatic Gastrointestinal Carcinoma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by evaluating recruitment rate (time frame: At end of enrollment (Up to 1 year)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.