Ignite Creation Date:
2024-05-06 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03538587
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2018-05-25
Brief Title:
Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 childrens 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
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 childrens 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 eg 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 n10 dyads compared to a psychoeducation control group n10 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 eg depression anxiety and physical eg pain fatigue wellbeing as well as baseline mindfulnessself-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
Children and young adults diagnosed with a high-grade or high-risk cancer eg 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 n10 dyads compared to a psychoeducation control group n10 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 eg depression anxiety and physical eg pain fatigue wellbeing as well as baseline mindfulnessself-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-C-0080 | None | None | None |