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Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Terminated

Conditions

Malignant Neoplasm

Treatments

Other: Questionnaire administration

Study type

Interventional

Funder types

Other

Identifiers

NCT04034914
VICC SUPP 1935
NCI-2019-04525 (Registry Identifier)

Details and patient eligibility

About

This trial studies how well Yoga works in supporting children with cancer and their parents during chemotherapy infusion. Pediatric cancer and its treatment is one of life's most stressful events for children and their parents. Yoga is an ancient holistic healing science that incorporates postures, breathing, relaxation, and meditation to facilitate harmony between body, mind, and spirit. Participating in Yoga exercise may improve the negative psychosocial effects in children with cancer and their parents during chemotherapy treatment.

Full description

PRIMARY OBJECTIVES:

  • To determine the feasibility of Yoga for children with cancer and their parents, specifically
  • Identify possible required modifications for safe and feasible practice during infusions.
  • Obtain recruitment estimates and determine barriers.
  • Assess satisfaction.

SECONDARY OBJECTIVES:

  • To determine the feasibility of administering and acceptability of measures to assess preliminary efficacy of Yoga for the following outcomes:
  • Child psychological distress (stress, anxiety).
  • Parent psychological distress (stress, anxiety, anger, depression).
  • Child and parent physiological stress (heart rate, respiratory rate, and blood pressure).
  • Parent-child communication.
  • Child physical symptoms.

OUTLINE:

Patients and parents participate in up to 8 Yoga sessions consisting of check in, awareness, breathing practices, gentle movement, and relaxation over 30 minutes each.

Enrollment

10 patients

Sex

All

Ages

8 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children: 8-17 years of age, within 4 weeks of: 1) any new cancer diagnosis or newly diagnosed relapsed cancer, and 2) medical clearance who anticipate 3-weeks of continous contact with Monroe Carell Jr. Children's Hospital.
  • Parents: 18 years of age and older, child's primary caregiver (planning to attend appointments, infusions visits, or be in hospital rooms/clinics) or secondary caregiver (an as needed back-up to primary).

Children and Parents: able to speak and understand English, absence of cognitive impairment, and willing to engage in Yoga as part of a dyad.

Exclusion criteria

  • CHILDREN: Medical conditions that would prohibit the safe implementation of a Yoga practice
  • PARENTS: Practices Yoga weekly
  • PARENTS: Pregnant or plans to become pregnant during next 3 months
  • CHILDREN AND PARENTS: Unwilling to work as a dyad.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Yoga Therapy
Experimental group
Treatment:
Other: Questionnaire administration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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