Quality of LifePhase 3NCT04303013
Guided Meditation During Radiotherapy.
A Phase 3 study testing Meditation in people with Quality of Life and Relaxation During Radiation Therapy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment. This study involves randomization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Relaxation During Radiation Therapy, Cancer
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 27 Mar 2023
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Prescribed a course of at least 15 daily fractions of RT for curative intent of any malignancy
- Willing to attend MBI sessions weekly during RT
- Able to transport themselves to scheduled MBI sessions in the DAHLC
- Able to complete questionnaire(s) by themselves
- Native English speaker (MBI sessions, videos, and QOL questionnaires are only available in English)
- ECOG Performance Status 0-2
Who cannot join
- Prescribed a course of RT with fewer than 15 consecutive, daily fractions
- Unable or unwilling to attend required MBI sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.
The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment.
This study involves randomization. There is a 50 percent chance (like a flip of the coin) that you will be randomized to attend meditation sessions during treatment.
- Being tested
- Meditation, Standard of Care
- Medical subject headings
- Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Patients will attend weekly in person guided meditation sessions during the course of their radiation treatment. Patient will complete quality of life surveys before, during and after treatment.
Standard of CareOther
Patient not assigned to meditation will undergo radiation with usual care and complete quality of life surveys before, during and after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Other: Standard of Care |
| Meditation | Experimental | Not described Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Meditation Sessions
including emotional, physical, functional, and social domains assessed via the FACT-G during and after radiotherapy for the treatment of cancer.
Measured: Before radiation treatment.
Effectiveness of Meditation Sessions
Comparison of change in total LASA-6 and single question relaxation surveys.
Measured: During radiation treatment
Effectiveness of Meditation Sessions
Comparison of change in FACT-G, Promis 10 and LASA-6 surveys.
Measured: 3 months and 12 months post radiation treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Jun 2019
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly S. Corbin, Mayo Clinic
- Investigators
- Kimberly S. Corbin, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303013
- Sponsor's protocol ID
- 18-004546
- Other IDs
- NCI-2021-02757
- Status last verified
- Aug 2023
- First submitted
- 26 Feb 2020
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.
- ClinicalTrials.gov ID
- NCT04303013
- Acronym / sponsor ID
- 18-004546
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 10 Mar 2020 (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.
The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment.
This study involves randomization. There is a 50 percent chance (like a flip of the coin) that you will be randomized to attend meditation sessions during treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of Care |
| Meditation | Experimental | Behavioral: Meditation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Prescribed a course of at least 15 daily fractions of RT for curative intent of any malignancy
- Willing to attend MBI sessions weekly during RT
- Able to transport themselves to scheduled MBI sessions in the DAHLC
- Able to complete questionnaire(s) by themselves
Key exclusion criteria (2 listed)
- Prescribed a course of RT with fewer than 15 consecutive, daily fractions
- Unable or unwilling to attend required MBI sessions
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 |
|---|---|---|
| MeditationPatients will attend weekly in person guided meditation sessions during the course of their radiation treatment. Patient will complete quality of life surveys before, during and after treatment. | Behavioural | Meditation |
| Standard of CarePatient not assigned to meditation will undergo radiation with usual care and complete quality of life surveys before, during and after treatment. | Other | Standard of Care |
Primary outcome
Effectiveness of Meditation Sessions
Time frame: Before radiation treatment.
including emotional, physical, functional, and social domains assessed via the FACT-G during and after radiotherapy for the treatment of cancer.
Effectiveness of Meditation Sessions
Time frame: During radiation treatment
Comparison of change in total LASA-6 and single question relaxation surveys.
Effectiveness of Meditation Sessions
Time frame: 3 months and 12 months post radiation treatment.
Comparison of change in FACT-G, Promis 10 and LASA-6 surveys.
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 1 Nov 2023.
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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.
Kimberly S. Corbin, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meditation in people with Quality of Life and Relaxation During Radiation Therapy, run by Mayo Clinic 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 7 inclusion and 2 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 1 Nov 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effectiveness of Meditation Sessions (time frame: Before radiation treatment.). The study lists 3 primary outcomes in all. 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 1 Nov 2023.