Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers

NCT03538587 | Completed Results

• 2 other identifiers: 18008018-C-0080
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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. ...

Conditions

Glioblastomas; Sarcoma; Astrocytoma; Brain Cancer; Leukemia

Keywords

Refractory Metastatic Sarcoma; Diffuse Intrinsic Pontine Glioma DIPG; Relapsed-Refractory Leukemia; Meditation; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  8 weeks from study entry

Other Outcomes (1)

• Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

  Date treatment consent signed to date off study, approximately 2-3 months.

Study Arms (2)

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.

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

Behavioral: Psychoeducation

Interventions

Enhanced Mindfulness Intervention BEHAVIORAL

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 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group

Psychoeducation BEHAVIORAL

The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline.

Arm 2 Control Group - Psychoeducation Group

Eligibility Criteria

• Age: 5 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Must have access to a computer/mobile device and the internet.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Glioblastoma; Sarcoma; Astrocytoma; Brain Neoplasms; Leukemia; Diffuse Intrinsic Pontine Glioma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Brain Stem Neoplasms; Infratentorial Neoplasms

Results Point of Contact

• Title: Staci M. Peron, Ph.D.
• Organization: National Cancer Institute

martins@mail.nih.gov

240-760-6025

Study Officials

• Staci M Peron, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: May 29, 2018
• Study Start: January 29, 2019
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).

Locations

US (1)