Clinical trial NCT04034914: Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion
Official title: A Preliminary Pilot Study to Tailor and Evaluate the Feasibility of Child and Parent Yoga (CAPY) During Chemotherapy Infusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Modifications
timeFrame: Up to 2 years
measure: Recruitment
timeFrame: Up to 2 years
measure: Retention
timeFrame: Up to 2 years
measure: Barriers
timeFrame: Up to 2 years
measure: Participant satisfaction
timeFrame: Up to 2 years
Secondary outcomes:
measure: Child psychological distress
timeFrame: Up to 2 years
measure: Parent psychological distress
timeFrame: Up to 2 years
measure: Parent psychological distress
timeFrame: Up to 2 years
measure: Parent psychological distress
timeFrame: Up to 2 years
measure: Child and parent physiological stress
timeFrame: Up to 2 years
measure: Child and parent physiological stress
timeFrame: Up to 2 years
measure: Child and parent physiological stress
timeFrame: Up to 2 years
measure: Parent-child communication
timeFrame: Up to 2 years
measure: Child physical symptoms
timeFrame: Up to 2 years
measure: Parent psychological distress
timeFrame: Up to 2 years
measure: Child psychological distress
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University School of Nursing
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Nursing
name: Sheila Ridner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University School of Nursing
name: Terrah Akard, PhD
role: PRINCIPAL_INVESTIGATOR
References: