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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-C-0080

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 5 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

glioblastomas;
Sarcoma;
Astrocytoma;
Brain Cancer;
Leukemia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Enhanced Mindfulness Intervention
Behavioral: Psychoeducation

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA FOR CHILDREN:

-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.

EXCLUSION CRITERIA FOR PATIENTS:

-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 conjuction with the study 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 conjuction with the study PI/adjunct PI.

INCLUSION CRITERIA FOR PARENT OR ADULT PRIMARY CAREGIVER:

-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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Staci M. Peron, Ph.D.
National Cancer Institute (NCI)
NIHBC 82 - RA BLOCH INTERNATIONAL CANCER CENTER BG RM 107
9030 OLD GEORGETOWN RD
BETHESDA MD 20892
(240) 760-6025
martins@mail.nih.gov

Staci M. Peron, Ph.D.
National Cancer Institute (NCI)
NIHBC 82 - RA BLOCH INTERNATIONAL CANCER CENTER BG RM 107
9030 OLD GEORGETOWN RD
BETHESDA MD 20892
(240) 760-6025
martins@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03538587

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