Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03538587|
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : January 19, 2021
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.
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.
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastomas Sarcoma Astrocytoma Brain Cancer Leukemia||Behavioral: Enhanced Mindfulness Intervention Behavioral: Psychoeducation||Not Applicable|
- 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.
-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.
- 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.
- This is a pilot randomized controlled trial that will compare feasibility and preliminary efficacy of an 8-week 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||April 1, 2022|
Active Comparator: 1/EMI Group
Participate in an in-person session followed by a series of at-home assignments, and two booster sessions
Behavioral: Enhanced Mindfulness Intervention
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.
Active Comparator: 2/Control Group
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
The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline
- Feasibility [ Time Frame: 8 weeks from study entry ]Descriptive and summary statistics will be used to report parent and child ratings of intervention completion, as well as satisfaction with the intervention via responses on a feasibility questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538587
|Contact: Katherine D McHugh||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Staci M Peron, Ph.D.||National Cancer Institute (NCI)|