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

NCT ID: NCT04034914

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-07
• Study Completion Date: 2020-06-30

Brief Summary

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.

Detailed 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.

Conditions

Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Yoga Therapy

Group Type: EXPERIMENTAL

Questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

Questionnaire administration

Ancillary studies

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Sheila Ridner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheila Ridner, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Nursing

Terrah Akard, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Nursing

Locations

Vanderbilt University School of Nursing

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

NCI-2019-04525

Identifier Type: REGISTRY

Identifier Source: secondary_id

VICC SUPP 1935

Identifier Type: -

Identifier Source: org_study_id