MindfulnessMEANINGNCT03257007
Mindfulness to Enhance Quality of Life and Support Advance Care Planning
A study testing Mindfulness in people with Mindfulness and Meditation, run by Indiana University at 1 site in United States.
Trial summary
The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel mindfulness meditation-based intervention (MEANING) to usual care for adults with advanced-stage solid malignancies and their family caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Meditation, Metastatic Cancer
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to 11 Dec 2017
- 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
- Patient is at least 18 years of age.
- Patient is at least 3 weeks post-diagnosis of an incurable (locally advanced or metastatic) solid malignancy.
- Patient's attending medical oncologist would not be surprised if the patient died in the next 12 months.
- Patient has not completed a POST form.
- Patient scores ≥ 7 on the Mini-Mental Adjustment to Cancer cognitive avoidance subscale.
- Patient is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
Show all 12Show fewer
- Patient has a family member or close friend eligible and interested in participating in the study.
- Patient has adequate English fluency for completion of data collection
- FCG is at least 18 years of age.
- FCG has been invited to participate in the trial with a patient who meets eligibility criteria above.
- FCG is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
- FCG has adequate English fluency for completion of data collection
Who cannot join
- Patient reports a score of > 2 on the Activities and Function item from the Patient Generated Subjective Global Assessment91 (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score).
- Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
- Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).
- FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING): A Randomized Controlled Pilot Trial for Adults With Metastatic Cancer and Their Family Caregivers
The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel mindfulness meditation-based intervention (MEANING) to usual care for adults with advanced-stage solid malignancies and their family caregivers.
Read the detailed description
Mindfulness meditation practices have reduced emotional distress, avoidant coping, and improved spiritual well-being in adult cancer patients. These beneficial effects may occur through present-moment acceptance of unpleasant thoughts, feelings, and circumstances and adaptive coping through self-awareness, self-regulation, and self-transcendence. Most mindfulness trials in cancer have focused on early-stage survivors; however, preliminary evidence suggests that mindfulness may help reduce distress in patients with advanced cancer and their family caregivers (FCGs).
Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be randomized in equal numbers to receive either the 6-week mindfulness intervention or usual care. Both groups will receive standard cancer care throughout the study period. Dyads randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body scan, sitting meditation) and mindful communication practices to enhance quality of life, support advance care planning engagement, and improve a variety of secondary outcomes.
The study will use a mixed methods 2-arm randomized design to examine the effects of the mindfulness intervention compared to usual care and seek to explain trial results using insights gleaned from post-intervention qualitative interviews.
- Conditions
- Mindfulness, Meditation, Metastatic Cancer, Quality of Life, Advance Care Planning, Palliative Care
- Being tested
- Mindfulness
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
The Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations. Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice. Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week. Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants assigned to Usual Care will continue to receive standard care from their oncology team, including access to supportive care from oncology social workers. At the end of the study, usual care dyads will receive a packet of informational materials on mindfulness meditation, receive a CD with 5 mindfulness meditation practices, and meet with the study interventionist for guidance on how to use the materials and mindfulness recordings to their advantage in coping with cancer-related challenges. |
| Mindfulness | Active comparator | The Mindfulness intervention will consist of six 2-hour sessions that will include guided mindfulness practices, didactics, and group discussion. The course curriculum is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue. Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in quality of life (QoL) for Patients
QoL for patients will be assessed with the McGill Quality of Life Inventory.
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in quality of life (QoL) for Family Caregivers
QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).
Measured: Baseline, 6 weeks, and 10 weeks
Secondary outcomes (15)
Change from baseline in advance care planning (ACP) stage of change
ACP stage of change will be assessed by a measure modified from Fried et. al assessing stage of change for 3 advance care planning behaviors (completing a living will, medical power of attorney form, or POLST form; patient only measure).
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in advance care planning (ACP) engagement
ACP engagement (self-efficacy, readiness) will be measured using 2 subscales of the Advance Care Planning Engagement Survey (patient only measure).
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in caregiver burden
Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only)
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in avoidant coping
Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in avoidant coping
Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in depressive symptoms
Depressive symptoms will be assessed using the PHQ-8
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in anxiety
Anxiety will be assessed using the GAD-7
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in spiritual well-being
Spiritual well-being will be measured using the FACIT-SP.
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in sleep disturbance
Sleep disturbance will be assessed using the PROMIS Sleep Disturbance.
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in family communication
Family communication will be assessed using the Social Constraint Scale
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in interpersonal closeness
Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale.
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in acceptance of illness
Acceptance of illness will be assessed using the PEACE Scale.
Measured: Baseline, 6 weeks, and 10 weeks
Change from baseline in mindfulness
Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales.
Measured: Baseline, 6 weeks, and 10 weeks
Distress Thermometer
Distress will be assessed using the Distress Thermometer.
Measured: Baseline, 6 weeks, and 10 weeks
Intervention satisfaction and helpfulness
Satisfaction and helpfulness with the Mindfulness intervention will be assessed using single-item investigator-created 7- and 10-point Likert scales, respectively (Mindfulness group only).
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 posted22 Aug 2017
- Study start9 May 2017
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
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 MindfulnessStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned in equal numbers using block randomization to the mindfulness intervention or usual care. The course curriculum for the mindfulness intervention is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelley Johns, Indiana University
- Investigators
- Shelley A Johns, PsyD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257007
- Sponsor's protocol ID
- 1702223546
- Acronym
- MEANING
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2017
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mosher CE, Beck-Coon KA, Wu W, Lewson AB, Stutz PV, Brown LF, Tang Q, Helft PR, Levoy K, Hickman SE, Johns SA. Mindfulness to enhance quality of life and support advance care planning: a pilot randomized controlled trial for adults with advanced cancer and their family caregivers. BMC Palliat Care. 2024 Sep 28;23(1):232. doi: 10.1186/s12904-024-01564-7.
PubMed 39342143
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING): A Randomized Controlled Pilot Trial for Adults With Metastatic Cancer and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT03257007
- Acronym / sponsor ID
- MEANING / 1702223546
- Conditions
- Mindfulness, Meditation, Metastatic Cancer, Quality of Life, Advance Care Planning, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 22 Aug 2017 (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 MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel mindfulness meditation-based intervention (MEANING) to usual care for adults with advanced-stage solid malignancies and their family caregivers.
Detailed description
Mindfulness meditation practices have reduced emotional distress, avoidant coping, and improved spiritual well-being in adult cancer patients. These beneficial effects may occur through present-moment acceptance of unpleasant thoughts, feelings, and circumstances and adaptive coping through self-awareness, self-regulation, and self-transcendence. Most mindfulness trials in cancer have focused on early-stage survivors; however, preliminary evidence suggests that mindfulness may help reduce distress in patients with advanced cancer and their family caregivers (FCGs).
Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be randomized in equal numbers to receive either the 6-week mindfulness intervention or usual care. Both groups will receive standard cancer care throughout the study period. Dyads randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body scan, sitting meditation) and mindful communication practices to enhance quality of life, support advance care planning engagement, and improve a variety of secondary outcomes.
The study will use a mixed methods 2-arm randomized design to examine the effects of the mindfulness intervention compared to usual care and seek to explain trial results using insights gleaned from post-intervention qualitative interviews.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned in equal numbers using block randomization to the mindfulness intervention or usual care. The course curriculum for the mindfulness intervention is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants assigned to Usual Care will continue to receive standard care from their oncology team, including access to supportive care from oncology social workers. At the end of the study, usual care dyads will receive a packet of informational materials on mindfulness meditation, receive a CD with 5 mindfulness meditation practices, and meet with the study interventionist for guidance on how to use the materials and mindfulness recordings to their advantage in coping with cancer-related challenges. |
| Mindfulness | Active comparator | Behavioral: MindfulnessThe Mindfulness intervention will consist of six 2-hour sessions that will include guided mindfulness practices, didactics, and group discussion. The course curriculum is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient is at least 18 years of age.
- Patient is at least 3 weeks post-diagnosis of an incurable (locally advanced or metastatic) solid malignancy.
- Patient's attending medical oncologist would not be surprised if the patient died in the next 12 months.
- Patient has not completed a POST form.
- Patient scores ≥ 7 on the Mini-Mental Adjustment to Cancer cognitive avoidance subscale.
Key exclusion criteria (4 listed)
- Patient reports a score of > 2 on the Activities and Function item from the Patient Generated Subjective Global Assessment91 (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score).
- Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
- Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).
- FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and 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 |
|---|---|---|
| MindfulnessThe Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations. Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice. Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week. Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills. | Behavioural | Mindfulness |
Primary outcome
Change from baseline in quality of life (QoL) for Patients
Time frame: Baseline, 6 weeks, and 10 weeks
QoL for patients will be assessed with the McGill Quality of Life Inventory.
Change from baseline in quality of life (QoL) for Family Caregivers
Time frame: Baseline, 6 weeks, and 10 weeks
QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).
15 secondary outcomes
Change from baseline in advance care planning (ACP) stage of change
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in advance care planning (ACP) engagement
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in caregiver burden
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in avoidant coping
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in avoidant coping
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in depressive symptoms
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in anxiety
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in spiritual well-being
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in sleep disturbance
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in family communication
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in interpersonal closeness
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in acceptance of illness
Time frame: Baseline, 6 weeks, and 10 weeks
Change from baseline in mindfulness
Time frame: Baseline, 6 weeks, and 10 weeks
Distress Thermometer
Time frame: Baseline, 6 weeks, and 10 weeks
Intervention satisfaction and helpfulness
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 12 Aug 2020.
- Derived from this study: PubMed 39342143Mosher CE, Beck-Coon KA, Wu W, Lewson AB, Stutz PV, Brown LF, Tang Q, Helft PR, Levoy K, Hickman SE, Johns SA. Mindfulness to enhance quality of life and support advance care planning: a pilot randomized controlled trial for adults with advanced cancer and their family caregivers. BMC Palliat Care. 2024 Sep 28;23(1):232. doi: 10.1186/s12904-024-01564-7.
- 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.
Shelley A Johns, PsyD principal investigator
Indiana University
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 in people with Mindfulness and Meditation, run by Indiana University 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 12 inclusion and 4 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 12 Aug 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?
Change from baseline in quality of life (QoL) for Patients (time frame: Baseline, 6 weeks, and 10 weeks). The study lists 2 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 NCT03257007, 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 12 Aug 2020.