Trial Outcomes & Findings for Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers (NCT NCT03538587)
NCT ID: NCT03538587
Last Updated: 2023-08-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
2 years
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
Arm 1/Enhanced Mindfulness Intervention (EMI) Group - Participate in an in-person session followed by a series of at-home assignments, and two booster sessions.
Enhanced Mindfulness Intervention: The 8-week EMI will consist of one initial in-person session with the child participant and parent (= 1 dyad), a series of at home assignments, and two "booster" sessions.
|
Arm 2 Control Group - Psychoeducation Group
Arm 2 Control Group - Psychoeducation 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.
Psychoeducation: The dyads (= 1 child participant and 1 caregiver) in 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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
Child Participants
|
2
|
3
|
|
Overall Study
Parent Participants
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number of participants analyzed = child and parent participants.
Baseline characteristics by cohort
| Measure |
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
n=4 Participants
Arm 1/Enhanced Mindfulness Intervention (EMI) Group - Participate in an in-person session followed by a series of at-home assignments, and two booster sessions.
Enhanced Mindfulness Intervention: 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.
|
Arm 2 Control Group - Psychoeducation Group
n=6 Participants
Arm 2 Control Group - Psychoeducation 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.
Psychoeducation: The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
Child participants
|
11.0 years
STANDARD_DEVIATION 2.82 • n=2 Participants • Number of participants analyzed = child and parent participants.
|
13.33 years
STANDARD_DEVIATION 4.73 • n=3 Participants • Number of participants analyzed = child and parent participants.
|
12.16 years
STANDARD_DEVIATION 3.77 • n=5 Participants • Number of participants analyzed = child and parent participants.
|
|
Age, Continuous
Parent participants
|
44.0 years
STANDARD_DEVIATION 5.66 • n=2 Participants • Number of participants analyzed = child and parent participants.
|
42.0 years
STANDARD_DEVIATION 6.56 • n=3 Participants • Number of participants analyzed = child and parent participants.
|
43.0 years
STANDARD_DEVIATION 6.11 • n=5 Participants • Number of participants analyzed = child and parent participants.
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
6 participants
n=6 Participants
|
10 participants
n=10 Participants
|
|
School Setting for Child Participants
Public
|
1 Participants
n=2 Participants • Analyzed = child participants only.
|
3 Participants
n=3 Participants • Analyzed = child participants only.
|
4 Participants
n=5 Participants • Analyzed = child participants only.
|
|
School Setting for Child Participants
Home School
|
1 Participants
n=2 Participants • Analyzed = child participants only.
|
0 Participants
n=3 Participants • Analyzed = child participants only.
|
1 Participants
n=5 Participants • Analyzed = child participants only.
|
|
Current School Grade Level for Child Participants
Grade 12
|
0 Participants
n=2 Participants • Analyzed = child participants only.
|
1 Participants
n=3 Participants • Analyzed = child participants only.
|
1 Participants
n=5 Participants • Analyzed = child participants only.
|
|
Current School Grade Level for Child Participants
Grade 10
|
0 Participants
n=2 Participants • Analyzed = child participants only.
|
1 Participants
n=3 Participants • Analyzed = child participants only.
|
1 Participants
n=5 Participants • Analyzed = child participants only.
|
|
Current School Grade Level for Child Participants
Grade 7
|
1 Participants
n=2 Participants • Analyzed = child participants only.
|
0 Participants
n=3 Participants • Analyzed = child participants only.
|
1 Participants
n=5 Participants • Analyzed = child participants only.
|
|
Current School Grade Level for Child Participants
Grade 4
|
1 Participants
n=2 Participants • Analyzed = child participants only.
|
0 Participants
n=3 Participants • Analyzed = child participants only.
|
1 Participants
n=5 Participants • Analyzed = child participants only.
|
|
Current School Grade Level for Child Participants
Grade 3
|
0 Participants
n=2 Participants • Analyzed = child participants only.
|
1 Participants
n=3 Participants • Analyzed = child participants only.
|
1 Participants
n=5 Participants • Analyzed = child participants only.
|
|
Occupation Status for Parent Participants
Working
|
1 Participants
n=2 Participants • Analyzed = parent participants only.
|
1 Participants
n=3 Participants • Analyzed = parent participants only.
|
2 Participants
n=5 Participants • Analyzed = parent participants only.
|
|
Occupation Status for Parent Participants
Not working
|
0 Participants
n=2 Participants • Analyzed = parent participants only.
|
1 Participants
n=3 Participants • Analyzed = parent participants only.
|
1 Participants
n=5 Participants • Analyzed = parent participants only.
|
|
Occupation Status for Parent Participants
On leave
|
1 Participants
n=2 Participants • Analyzed = parent participants only.
|
0 Participants
n=3 Participants • Analyzed = parent participants only.
|
1 Participants
n=5 Participants • Analyzed = parent participants only.
|
|
Occupation Status for Parent Participants
Disability
|
0 Participants
n=2 Participants • Analyzed = parent participants only.
|
1 Participants
n=3 Participants • Analyzed = parent participants only.
|
1 Participants
n=5 Participants • Analyzed = parent participants only.
|
|
Marital Status
Single
|
0 Participants
n=2 Participants • Analyzed = parent participants only.
|
1 Participants
n=3 Participants • Analyzed = parent participants only.
|
1 Participants
n=5 Participants • Analyzed = parent participants only.
|
|
Marital Status
Married
|
2 Participants
n=2 Participants • Analyzed = parent participants only.
|
2 Participants
n=3 Participants • Analyzed = parent participants only.
|
4 Participants
n=5 Participants • Analyzed = parent participants only.
|
|
Number of Parent Participants Working (Hours/Weeks)
40 Hours/Week
|
0 Participants
n=2 Participants • Analyzed = parent participants only.
|
1 Participants
n=3 Participants • Analyzed = parent participants only.
|
1 Participants
n=5 Participants • Analyzed = parent participants only.
|
|
Number of Parent Participants Working (Hours/Weeks)
37 Hours/Week
|
1 Participants
n=2 Participants • Analyzed = parent participants only.
|
0 Participants
n=3 Participants • Analyzed = parent participants only.
|
1 Participants
n=5 Participants • Analyzed = parent participants only.
|
|
Number of Parent Participants Working (Hours/Weeks)
Not Working
|
1 Participants
n=2 Participants • Analyzed = parent participants only.
|
2 Participants
n=3 Participants • Analyzed = parent participants only.
|
3 Participants
n=5 Participants • Analyzed = parent participants only.
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Each dyad = 1 child, 1 parent. Two dyads were analyzed in group 1 (i.e., 2 children, 2 parents), and three dyads were analyzed in group 2 (i.e., 3 children, 3 parents).
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).
Outcome measures
| Measure |
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
n=2 Participants
Arm 1/Enhanced Mindfulness Intervention (EMI) Group - Participate in an in-person session followed by a series of at-home assignments, and two booster sessions.
Enhanced Mindfulness Intervention: The 8-week EMI will consist of one initial in-person session with the child participant and parent (= 1 dyad), a series of at home assignments, and two "booster" sessions.
|
Arm 2 Control Group - Psychoeducation Group
n=3 Participants
Arm 2 Control Group - Psychoeducation 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.
Psychoeducation: The dyads (= 1 child participant and 1 caregiver) in 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.
|
|---|---|---|
|
Percentage of Eligible Dyads (Parent-child) Who Enroll During a Two-year Period
|
100 percentage of dyads
|
100 percentage of dyads
|
PRIMARY outcome
Timeframe: 8 weeks from study entryPercent 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.
Outcome measures
| Measure |
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
n=4 Participants
Arm 1/Enhanced Mindfulness Intervention (EMI) Group - Participate in an in-person session followed by a series of at-home assignments, and two booster sessions.
Enhanced Mindfulness Intervention: The 8-week EMI will consist of one initial in-person session with the child participant and parent (= 1 dyad), a series of at home assignments, and two "booster" sessions.
|
Arm 2 Control Group - Psychoeducation Group
n=6 Participants
Arm 2 Control Group - Psychoeducation 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.
Psychoeducation: The dyads (= 1 child participant and 1 caregiver) in 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.
|
|---|---|---|
|
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
|
50 percentage of participants(parent/child)
|
33 percentage of participants(parent/child)
|
PRIMARY outcome
Timeframe: For 8 weeks from study entryCompliance 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.
Outcome measures
| Measure |
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
n=4 Participants
Arm 1/Enhanced Mindfulness Intervention (EMI) Group - Participate in an in-person session followed by a series of at-home assignments, and two booster sessions.
Enhanced Mindfulness Intervention: The 8-week EMI will consist of one initial in-person session with the child participant and parent (= 1 dyad), a series of at home assignments, and two "booster" sessions.
|
Arm 2 Control Group - Psychoeducation Group
n=6 Participants
Arm 2 Control Group - Psychoeducation 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.
Psychoeducation: The dyads (= 1 child participant and 1 caregiver) in 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.
|
|---|---|---|
|
Percent of Participants Who Completed a Mean of 4 Days/Week At-home Practices or More
|
25 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 8 weeks from study entryPopulation: Each dyad = 1 child, 1 parent. Half a dyad was analyzed in group 1 (i.e., 1 child), and 1 dyad (i.e., 1 child, 1 parent) was analyzed in group 2. Measure type "Number" is used instead of "Mean" because you cannot compute a mean from only one data point. Unfortunately, not enough participants completed this study measure to calculate means and standard deviations.
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.
Outcome measures
| Measure |
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
n=1 Participants
Arm 1/Enhanced Mindfulness Intervention (EMI) Group - Participate in an in-person session followed by a series of at-home assignments, and two booster sessions.
Enhanced Mindfulness Intervention: The 8-week EMI will consist of one initial in-person session with the child participant and parent (= 1 dyad), a series of at home assignments, and two "booster" sessions.
|
Arm 2 Control Group - Psychoeducation Group
n=2 Participants
Arm 2 Control Group - Psychoeducation 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.
Psychoeducation: The dyads (= 1 child participant and 1 caregiver) in 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.
|
|---|---|---|
|
Score on a Scale for Caregiver/Children Reports of Satisfaction on the Feasibility Questionnaire
Child Participants
|
1.83 score on a scale
|
3.5 score on a scale
|
|
Score on a Scale for Caregiver/Children Reports of Satisfaction on the Feasibility Questionnaire
Parent Participants
|
—
|
3.67 score on a scale
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 2-3 months.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
n=4 Participants
Arm 1/Enhanced Mindfulness Intervention (EMI) Group - Participate in an in-person session followed by a series of at-home assignments, and two booster sessions.
Enhanced Mindfulness Intervention: The 8-week EMI will consist of one initial in-person session with the child participant and parent (= 1 dyad), a series of at home assignments, and two "booster" sessions.
|
Arm 2 Control Group - Psychoeducation Group
n=6 Participants
Arm 2 Control Group - Psychoeducation 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.
Psychoeducation: The dyads (= 1 child participant and 1 caregiver) in 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.
|
|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 Control Group - Psychoeducation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place