Yoga Intervention in Supporting Children with Cancer and Their Parents during Chemotherapy Infusion

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • CHILDREN: 8-17 years of age
  • CHILDREN: Within 4 weeks of any new cancer diagnosis
  • CHILDREN: Medical clearance
  • PARENTS: 18 years of age and older
  • PARENTS: Child’s primary caregiver (planning to attend infusion visits) or secondary caregiver (an as needed back-up to primary)
  • 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
  • Unwilling to complete Yoga homework assignments

Locations & Contacts

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Sheila H. Ridner
Phone: 615-322-0831

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the feasibility of Yoga for children with cancer and their parents, specifically to:

Ia. Identify possible required modifications for safe and feasible practice during infusions.

Ib. Obtain recruitment estimates and determine barriers.

Ic. Assess satisfaction.

SECONDARY OBJECTIVES:

I. To determine the feasibility of administering and acceptability of measures to assess preliminary efficacy of Yoga for the following outcomes:

Ia. Child psychological distress (stress, anxiety).

Ib. Parent psychological distress (stress, anxiety, anger, depression).

Ic. Child and parent physiological stress (heart rate, respiratory rate, and blood pressure).

Id. Parent-child communication.

Ie. 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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Vanderbilt University / Ingram Cancer Center

Principal Investigator
Sheila H. Ridner

Trial IDs

Primary ID VICC SUPP 1935
Secondary IDs NCI-2019-04525
Clinicaltrials.gov ID NCT04034914