CancerNCT05098002
Mindfulness Meditation
A study testing Mindfulness program in people with Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
To offer Roswell Park patients and caregivers a variety of options to reduce their stress and improve their psychological well-being amidst the difficulty of cancer Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Mindfulness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2022to 28 Nov 2023
- 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
- Being over 18 years old
- Cancer survivor or a caregiver of cancer patient/survivor.
Who cannot join
- Unwilling or unable to complete the assessment in English.
- Are unwilling or unable to follow protocol requirements.
- Have any condition which in the Investigator's opinion deems the subject an unsuitable candidate to participate in this study including (based on criteria from the Mindfulness-based stress reduction (MBSR) authorized curriculum guide):
- Drug addiction (or recent recovery)
- Bereavement (recent loss)
- Mental health inpatient (recently discharged)
- Current depression or other major psychiatric diagnoses (including suicidality or suicidal ideation) that would interfere with participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
About this study
To offer Roswell Park patients and caregivers a variety of options to reduce their stress and improve their psychological well-being amidst the difficulty of cancer
- Conditions
- Cancer
- Being tested
- Mindfulness program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness programBehavioural
6 week class designed to improve psychological well-being
| Study group | Role | What they receive |
|---|---|---|
| Mindful based stress classes | Experimental | 6 week mindfulness program Receives: Behavioral: Mindfulness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Enrollment rates
Number of participants enrolled in virtual classes vs in person classes
Measured: 6 weeks
Secondary outcomes (1)
Acceptability
Percentage of participants who choose in person classes vs. virtual classess
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start2 Jan 2022
- Primary completion28 Feb 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Bouchard, MD, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098002
- Sponsor's protocol ID
- I 1946021
- Status last verified
- Feb 2024
- First submitted
- 18 Oct 2021
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation
- ClinicalTrials.gov ID
- NCT05098002
- Acronym / sponsor ID
- I 1946021
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 28 Oct 2021 (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.
To offer Roswell Park patients and caregivers a variety of options to reduce their stress and improve their psychological well-being amidst the difficulty of cancer
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindful based stress classes | Experimental | Behavioral: Mindfulness program6 week mindfulness program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being over 18 years old
- Cancer survivor or a caregiver of cancer patient/survivor.
Key exclusion criteria (7 listed)
- Unwilling or unable to complete the assessment in English.
- Are unwilling or unable to follow protocol requirements.
- Have any condition which in the Investigator's opinion deems the subject an unsuitable candidate to participate in this study including (based on criteria from the Mindfulness-based stress reduction (MBSR) authorized curriculum guide):
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 |
|---|---|---|
| Mindfulness program6 week class designed to improve psychological well-being | Behavioural | Mindful based stress classes |
Primary outcome
Feasibility - Enrollment rates
Time frame: 6 weeks
Number of participants enrolled in virtual classes vs in person classes
1 secondary outcome
Acceptability
Time frame: 6 weeks
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 16 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth Bouchard, MD principal investigator
Roswell Park Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness program in people with Cancer, run by Roswell Park Cancer Institute 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 2 inclusion and 7 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 16 Feb 2024. 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 - Enrollment rates (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2024.