GlioblastomasNCT03538587
Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers
A study testing Enhanced Mindfulness Intervention and Psychoeducation in people with Glioblastomas and Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: People cope with cancer in different ways. Mindfulness means focusing on the present moment with an open mind. Researchers want to see if this can help children and young adults with a high-grade high-risk cancer with poor prognosis. Read more about this study
- Who is it for?
- Ages 5 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioblastomas, Sarcoma, Astrocytoma
- What is being tested?
- Enhanced Mindfulness Intervention and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients diagnosed with a high-risk/high-grade cancer (e.g., high-grade brain tumors, relapsed/refractory acute lymphoblastic leukemia, acute myeloid leukemia, high-grade sarcoma) characterized by poor prognosis (e.g., estimated 5-year survival rate <30% based on scientific consensus in the literature, where available, or by expert physician report), as confirmed by medical record review.
- Patients with active disease
- Age greater than or equal to 5 years and less than or equal to 24 years of age
- Must be able to speak and understand English.
- Must have a parent or adult primary caregiver willing to participate in the study.
- Ability of subject or parent/guardian to understand and the willing to sign a written informed consent document.
Show all 12Show fewer
- Must have access to a computer/mobile device and the internet.
- Must be a parent or primary caregiver of a child (age 5 to 24 years of age) who has been diagnosed with a high-grade/high risk tumor that carries poor prognosis (as defined above); and must live in the same household as the patient for a majority of the time.
- Must have a child willing to participate in the study
- Must be able to speak and understand English.
- Ability of subject to understand and the willing to sign a written informed consent document.
- Must have access to a computer/mobile device and the internet.
Who cannot join
- Patients will be excluded if there is evidence of pre-morbid severe cognitive or psychiatric disability that would impair their capacity for participation or completion of evaluations in the judgment of the investigators.
- Evidence of disease progression at the time of referral to this study to the extent that it would impede participation or completion of evaluations as determined by the medical advisory investigator in conjunction with the study principal investigator (PI)/adjunct PI.
- Patients with treatment-related sequelae so severe that they would be unable to complete the study-related evaluations or intervention (e.g., treatment toxicity) as determined by the medical advisory investigator in conjunction with the study PI/adjunct PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Feasibility and Preliminary Efficacy of an Enhanced Mindfulness Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers: A Pilot Randomized Controlled Trial
Background:
People cope with cancer in different ways. Mindfulness means focusing on the present moment with an open mind. Researchers want to see if this can help children and young adults with a high-grade high-risk cancer with poor prognosis.
Read more
Objective:
To learn if mindfulness is feasible and acceptable for children and young people with high-grade high-risk cancer with poor prognosis and their caregivers.
Eligibility:
Children ages 5-24 with a high-grade or high-risk cancer, with a caregiver who agrees to do the study
Must have internet access (participants may borrow an iPod for the study)
Must speak English
Design:
All participants will complete questionnaires. These will be about feelings, physical well-being, quality of life, and mindfulness.
Researchers will review children's medical records.
Participants will be randomly put in the mindfulness group or the standard care group.
Participants in the standard care group will:
Get general recommendations for coping with cancer
Have check-in sessions 1 and 3 weeks after starting. These will last about 10 minutes each.
After participants finish the standard care group, they may be able to enroll in the mindfulness group.
Participants in the mindfulness group will:
Attend an in-person mindfulness training session. The child participant will meet with one research team member for 90 minutes while the parent participant meets with another. Then they will come together for a half hour.
Practice mindfulness exercises at least 4 days a week for 8 weeks.
Be asked to respond to weekly emails or texts asking about their mindfulness practice
Get a mindfulness kit with things to help them do their mindfulness activities at home.
Have a 30-minute check-in with their coach 1 and 3 weeks after starting. This can be in person or by video chat.
All participants (from both groups) will be asked to answer follow-up questions about 8 and 16 weeks after starting the study. Participants will be paid $20 for each set of questionnaires they complete to thank them for their time.
...
Read the detailed description
Background
- Children and young adults diagnosed with a high-grade or high-risk cancer (e.g., diffuse intrinsic pontine glioma, glioblastoma multiforme, relapsed-refractory leukemia, refractory metastatic sarcomas) face a poor prognosis given limited curative options.
- Recent research has indicated that this population of patients and their parents experience elevated stress and poorer health-related quality of life (HRQL) relative to normative samples.
- Recently published psychosocial standards of care in pediatric oncology strongly recommend that children diagnosed with cancer and their caregivers receive early and continued assessment of their wellbeing and have access to interventions to optimize functioning and HRQL. In addition, there is increasing recognition of the importance of palliative interventions early in the disease trajectory.
- Despite this recommendation, minimal research has examined supportive care interventions for this population early in the disease trajectory.
- Mindfulness-based interventions (MBIs) have empirical support for their feasibility and efficacy in alleviating emotional distress and physical symptoms in children and adults with chronic health conditions, including terminally-ill patients and their caregivers.
Objectives
-To assess the feasibility of an enhanced mindfulness intervention (EMI) in children and young adults (ages 5-24 years) with a high-grade or high-risk cancer with poor prognosis and one of their primary caregivers.
Eligibility
- Children and young adults ages 5-24 years and a parent or adult primary caregiver
- Diagnosis of a high-grade or high-risk cancer with poor prognosis
- English speaking
- Must have access to a mobile device or computer with internet.
- Potential participants will be excluded if there is evidence of pre-morbid severe cognitive or psychiatric disability in parent or child that would impair their capacity for participation, or if there is evidence of clinical disease progression at the time of referral to this study, such that it would prevent the child from engaging in the intervention.
Design
- This is a pilot randomized controlled trial that will compare feasibility and preliminary efficacy of an 8-week enhanced mindfulness intervention (EMI) group (n=10 dyads) compared to a psychoeducation control group (n=10 dyads).
- All participants will complete measures of feasibility (primary outcome) and exploratory outcomes at baseline and following the 8-week intervention. Exploratory measures will include emotional (e.g., depression, anxiety) and physical (e.g., pain, fatigue) wellbeing, as well as baseline mindfulness/self-compassion.
- The 8-week EMI will consist of one initial in-person session with the child and parent, a series of at-home assignments, and two booster sessions. The psychoeducation group will be given educational material about coping with cancer.
- The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline
- Conditions
- Glioblastomas, Sarcoma, Astrocytoma, Brain Cancer, Leukemia
- Being tested
- Enhanced Mindfulness Intervention, Psychoeducation
- Keywords
- Refractory Metastatic Sarcoma, Diffuse Intrinsic Pontine Glioma DIPG, Relapsed-Refractory Leukemia, Meditation, Quality of Life
- Medical subject headings
- Glioblastoma, Sarcoma, Astrocytoma, Brain Neoplasms, Leukemia, Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Mindfulness InterventionBehavioural
The 8-week EMI will consist of one initial in-person session with the participant and parent, a series of at home assignments, and two "booster" sessions. The psychoeducation group will be given educational material about coping with cancer.
PsychoeducationBehavioural
The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group | Active comparator | Participate in an in-person session followed by a series of at-home assignments, and two booster sessions. Receives: Behavioral: Enhanced Mindfulness Intervention |
| Arm 2 Control Group - Psychoeducation Group | Active comparator | Participants will briefly meet with a member of the research team who will assess parent and child coping, and provide the child- caregiver dyad educational material about coping with cancer Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Dyads (Parent-child) Who Enroll During a Two-year Period
Percentage of eligible dyads (1 parent, 1 child) who enroll during a two-year period (the number of dyads who enrolled divided by the number of dyads who were found eligible).
Measured: 2 years
Percent of Participants (Parent/Child) With Treatment Specific Retention Among All Randomized Participants, With a Target Retention Rate of 70% Over the 8 Week EMI/Control Period
Percent of participants who completed the study among those who enrolled and were randomized, with a target retention rate of 70% over the 8 Week EMI/control period.
Measured: 8 weeks from study entry
Percent of Participants Who Completed a Mean of 4 Days/Week At-home Practices or More
Compliance with at-home practices (e.g., at home assignments), with a proposed target rate of at least 4 out of 7 days per week on average over the 8 weeks. This will be measured in phone interviews and recorded on a study form.
Measured: For 8 weeks from study entry
Score on a Scale for Caregiver/Children Reports of Satisfaction on the Feasibility Questionnaire
The Feasibility questionnaire is a 12-item measure created by the researchers to assess satisfaction with the study. The first 6 items are on 5-point Likert scales and ask how helpful various aspects of the intervention were. Satisfaction scores are the mean of items 1-6 for both the caregiver and child forms, with possible scores ranging from 1 to 5. Higher scores represent more satisfaction. For youth ages 8+ and caregivers, average item scores of >3.0 reflect adequate satisfaction.
Measured: 8 weeks from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start29 Jan 2019
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomasStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Staci Peron, Ph.D., National Cancer Institute (NCI)
- Investigators
- Staci M Peron, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538587
- Sponsor's protocol ID
- 180080
- Other IDs
- 18-C-0080
- Status last verified
- Jul 2023
- First submitted
- 25 May 2018
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of an Enhanced Mindfulness Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03538587
- Acronym / sponsor ID
- 180080
- Conditions
- Glioblastomas, Sarcoma, Astrocytoma, Brain Cancer, Leukemia
- Keywords
- Refractory Metastatic Sarcoma, Diffuse Intrinsic Pontine Glioma DIPG, Relapsed-Refractory Leukemia, Meditation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
People cope with cancer in different ways. Mindfulness means focusing on the present moment with an open mind. Researchers want to see if this can help children and young adults with a high-grade high-risk cancer with poor prognosis.
Objective:
To learn if mindfulness is feasible and acceptable for children and young people with high-grade high-risk cancer with poor prognosis and their caregivers.
Eligibility:
Children ages 5-24 with a high-grade or high-risk cancer, with a caregiver who agrees to do the study
Must have internet access (participants may borrow an iPod for the study)
Must speak English
Design:
All participants will complete questionnaires. These will be about feelings, physical well-being, quality of life, and mindfulness.
Researchers will review children's medical records.
Participants will be randomly put in the mindfulness group or the standard care group.
Participants in the standard care group will:
Get general recommendations for coping with cancer
Have check-in sessions 1 and 3 weeks after starting. These will last about 10 minutes each.
After participants finish the standard care group, they may be able to enroll in the mindfulness group.
Participants in the mindfulness group will:
Attend an in-person mindfulness training session. The child participant will meet with one research team member for 90 minutes while the parent participant meets with another. Then they will come together for a half hour.
Practice mindfulness exercises at least 4 days a week for 8 weeks.
Be asked to respond to weekly emails or texts asking about their mindfulness practice
Get a mindfulness kit with things to help them do their mindfulness activities at home.
Have a 30-minute check-in with their coach 1 and 3 weeks after starting. This can be in person or by video chat.
All participants (from both groups) will be asked to answer follow-up questions about 8 and 16 weeks after starting the study. Participants will be paid $20 for each set of questionnaires they complete to thank them for their time.
...
Detailed description
Background
- Children and young adults diagnosed with a high-grade or high-risk cancer (e.g., diffuse intrinsic pontine glioma, glioblastoma multiforme, relapsed-refractory leukemia, refractory metastatic sarcomas) face a poor prognosis given limited curative options.
- Recent research has indicated that this population of patients and their parents experience elevated stress and poorer health-related quality of life (HRQL) relative to normative samples.
- Recently published psychosocial standards of care in pediatric oncology strongly recommend that children diagnosed with cancer and their caregivers receive early and continued assessment of their wellbeing and have access to interventions to optimize functioning and HRQL. In addition, there is increasing recognition of the importance of palliative interventions early in the disease trajectory.
- Despite this recommendation, minimal research has examined supportive care interventions for this population early in the disease trajectory.
- Mindfulness-based interventions (MBIs) have empirical support for their feasibility and efficacy in alleviating emotional distress and physical symptoms in children and adults with chronic health conditions, including terminally-ill patients and their caregivers.
Objectives
-To assess the feasibility of an enhanced mindfulness intervention (EMI) in children and young adults (ages 5-24 years) with a high-grade or high-risk cancer with poor prognosis and one of their primary caregivers.
Eligibility
- Children and young adults ages 5-24 years and a parent or adult primary caregiver
- Diagnosis of a high-grade or high-risk cancer with poor prognosis
- English speaking
- Must have access to a mobile device or computer with internet.
- Potential participants will be excluded if there is evidence of pre-morbid severe cognitive or psychiatric disability in parent or child that would impair their capacity for participation, or if there is evidence of clinical disease progression at the time of referral to this study, such that it would prevent the child from engaging in the intervention.
Design
- This is a pilot randomized controlled trial that will compare feasibility and preliminary efficacy of an 8-week enhanced mindfulness intervention (EMI) group (n=10 dyads) compared to a psychoeducation control group (n=10 dyads).
- All participants will complete measures of feasibility (primary outcome) and exploratory outcomes at baseline and following the 8-week intervention. Exploratory measures will include emotional (e.g., depression, anxiety) and physical (e.g., pain, fatigue) wellbeing, as well as baseline mindfulness/self-compassion.
- The 8-week EMI will consist of one initial in-person session with the child and parent, a series of at-home assignments, and two booster sessions. The psychoeducation group will be given educational material about coping with cancer.
- The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group | Active comparator | Behavioral: Enhanced Mindfulness InterventionParticipate in an in-person session followed by a series of at-home assignments, and two booster sessions. |
| Arm 2 Control Group - Psychoeducation Group | Active comparator | Behavioral: PsychoeducationParticipants will briefly meet with a member of the research team who will assess parent and child coping, and provide the child- caregiver dyad educational material about coping with cancer |
Who may qualify
- Ages
- 5 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Patients diagnosed with a high-risk/high-grade cancer (e.g., high-grade brain tumors, relapsed/refractory acute lymphoblastic leukemia, acute myeloid leukemia, high-grade sarcoma) characterized by poor prognosis (e.g., estimated 5-year survival rate <30% based on scientific consensus in the literature, where available, or by expert physician report), as confirmed by medical record review.
- Patients with active disease
- Age greater than or equal to 5 years and less than or equal to 24 years of age
- Must be able to speak and understand English.
- Must have a parent or adult primary caregiver willing to participate in the study.
Key exclusion criteria (3 listed)
- Patients will be excluded if there is evidence of pre-morbid severe cognitive or psychiatric disability that would impair their capacity for participation or completion of evaluations in the judgment of the investigators.
- Evidence of disease progression at the time of referral to this study to the extent that it would impede participation or completion of evaluations as determined by the medical advisory investigator in conjunction with the study principal investigator (PI)/adjunct PI.
- Patients with treatment-related sequelae so severe that they would be unable to complete the study-related evaluations or intervention (e.g., treatment toxicity) as determined by the medical advisory investigator in conjunction with the study PI/adjunct PI.
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 |
|---|---|---|
| Enhanced Mindfulness InterventionThe 8-week EMI will consist of one initial in-person session with the participant and parent, a series of at home assignments, and two "booster" sessions. The psychoeducation group will be given educational material about coping with cancer. | Behavioural | Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group |
| PsychoeducationThe psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline. | Behavioural | Arm 2 Control Group - Psychoeducation Group |
Primary outcome
Percentage of Eligible Dyads (Parent-child) Who Enroll During a Two-year Period
Time frame: 2 years
Percentage of eligible dyads (1 parent, 1 child) who enroll during a two-year period (the number of dyads who enrolled divided by the number of dyads who were found eligible).
Percent of Participants (Parent/Child) With Treatment Specific Retention Among All Randomized Participants, With a Target Retention Rate of 70% Over the 8 Week EMI/Control Period
Time frame: 8 weeks from study entry
Percent of participants who completed the study among those who enrolled and were randomized, with a target retention rate of 70% over the 8 Week EMI/control period.
Percent of Participants Who Completed a Mean of 4 Days/Week At-home Practices or More
Time frame: For 8 weeks from study entry
Compliance with at-home practices (e.g., at home assignments), with a proposed target rate of at least 4 out of 7 days per week on average over the 8 weeks. This will be measured in phone interviews and recorded on a study form.
Score on a Scale for Caregiver/Children Reports of Satisfaction on the Feasibility Questionnaire
Time frame: 8 weeks from study entry
The Feasibility questionnaire is a 12-item measure created by the researchers to assess satisfaction with the study. The first 6 items are on 5-point Likert scales and ask how helpful various aspects of the intervention were. Satisfaction scores are the mean of items 1-6 for both the caregiver and child forms, with possible scores ranging from 1 to 5. Higher scores represent more satisfaction. For youth ages 8+ and caregivers, average item scores of >3.0 reflect adequate satisfaction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
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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.
Staci M Peron, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Mindfulness Intervention and Psychoeducation in people with Glioblastomas and Sarcoma, run by National Cancer Institute (NCI) 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 3 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 Aug 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eligible Dyads (Parent-child) Who Enroll During a Two-year Period (time frame: 2 years). The study lists 4 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 Aug 2023.