Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion
- Conditions
- Malignant Neoplasm
- Interventions
- Other: Questionnaire administration
- Registration Number
- NCT04034914
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Yoga Therapy Questionnaire administration -
- Primary Outcome Measures
Name Time Method Retention Up to 2 years 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.
Participant satisfaction Up to 2 years 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.
Modifications Up to 2 years Will be assessed qualitatively. A tally of the specific modifications will be maintained to determine if particular modification are made more frequently than others.
Recruitment Up to 2 years The total number of eligible child-parent dyads approached to achieve an enrolled sample of 5 dyads will be tallied.
Barriers Up to 2 years 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.
- Secondary Outcome Measures
Name Time Method Parent-child communication Up to 2 years 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.
Child psychological distress Up to 2 years Child distress will be assessed using the PROMIS Pediatric Anxiety - Short Form
Parent psychological distress Up to 2 years Parent distress will be assessed using the NIH Toolbox Perceived Stress
Child and parent physiological stress Up to 2 years Will assess respiratory rate
Child physical symptoms Up to 2 years Will be assessed using the PROMIS Pediatric Physical Stress Experiences -Short Form.
Trial Locations
- Locations (1)
Vanderbilt University School of Nursing
🇺🇸Nashville, Tennessee, United States