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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Preliminary Pilot Study to Tailor and Evaluate the Feasibility of Child and Parent Yoga (CAPY) During Chemotherapy Infusion

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Other: Questionnaire administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Therapy<br> | Other: Questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modifications | Will be assessed qualitatively. A tally of the specific modifications will be maintained to determine if particular modification are made more frequently than others. | Up to 2 years | 
| Recruitment | The total number of eligible child-parent dyads approached to achieve an enrolled sample of 5 dyads will be tallied. | Up to 2 years | 
| Retention | The number of the enrolled child-parent dyads who complete both the self-report assessments required at baseline (T1 - prior to first Yoga session), the Yoga protocol, and the measures at the end-of-infusion (T2 - prior to last Yoga session) will be tallied. The proportion completing will be used to inform the level of over-recruitment required in future studies of efficacy. | Up to 2 years | 
| Barriers | Participants who do not complete the study will be contacted and queried as to the reason for the lack of completion. A tally of the specific barriers will be maintained to determine if particular barriers are encountered more frequently than others. This information will inform possible modifications required to the protocol in future research. | Up to 2 years | 
| Participant satisfaction | The total number of responses to the 14 satisfaction questions with a rating > 4 (maximum rating = 7) will be generated for each of the 5 parent participants. It is expected that all participants will exceed that threshold for all questions. If not, frequency distributions will be used to summarize the responses to each of the 14 items to assess which produced the lower ratings. Responses to open-ended questions will be analyzed qualitatively. Findings from both components of the satisfaction survey (program satisfaction and yoga survey) will be used to revise the Yoga protocol as needed. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child psychological distress | Will assess child distress using Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Psychological Stress Experiences- Short Form | Up to 2 years | 
| Parent psychological distress | Will assess parent distress using the PROMIS Depression - Short Form | Up to 2 years | 
| Parent psychological distress | Will assess parent distress using the PROMIS Emotional Distress - Anger - Short Form | Up to 2 years | 
| Parent psychological distress | Will assess parent distress using the PROMIS Anxiety | Up to 2 years | 
| Child and parent physiological stress | Will assess blood pressure | Up to 2 years | 
| Child and parent physiological stress | Will assess heart rate | Up to 2 years | 
| Child and parent physiological stress | Will assess respiratory rate | Up to 2 years | 
| Parent-child communication | Will be assessed using the Parent-Adolescent Communication Scale (PACS). Participants answer 20-40 questions. A total score is calculated ranging from 20-100 with higher scores indicating more positive communication. | Up to 2 years | 
| Child physical symptoms | Will be assessed using the PROMIS Pediatric Physical Stress Experiences -Short Form. | Up to 2 years | 
| Parent psychological distress | Parent distress will be assessed using the NIH Toolbox Perceived Stress | Up to 2 years | 
| Child psychological distress | Child distress will be assessed using the PROMIS Pediatric Anxiety - Short Form | Up to 2 years |