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Spots Global Cancer Trial Database for Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being

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Trial Identification

Brief Title: Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being

Official Title: Pilot Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being

Study ID: NCT02899117

Conditions

Neoplasms

Interventions

Yoga

Study Description

Brief Summary: The proposed project will examine feasibility and preliminary efficacy of a yoga intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes two parts: (1) a survey of children and parents regarding preferences (e.g., convenient days/times), experiences and expectations regarding yoga (including barriers and positive expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of children and parents.

Detailed Description: The specific aims and hypotheses for this seed grant are to collect and assess data on: Aim 1 feasibility - perceived barriers/solutions, interest and accrual rates, attendance per session, participant retention, evidence of institutional support and resource commitment Hypothesis 1: A yoga intervention is feasible among pediatric oncology patients and their parents; (2) preliminary efficacy - including effect sizes for calculating power Hypothesis 2a: A yoga intervention improves pediatric oncology patients' fatigue, QOL, and sleep. Hypothesis 2b: A yoga intervention improves parental QOL and caregiver burden. We will be using the following questionnaires and scales to help answer the quesitons related to the hypotheses and aims: PedsQL 4.0 PedsQL 3.0 Cancer Module The Fatigue Scale SleepDiary Actigraphy data. Child Home Yoga Practice Diary Satisfaction survey Questionnaires noted below are given only to the parents: SF-12 Zarit Caregiver Burden Index Yoga Satisfaction Survey Study participants will have 4 yoga sessions and the questionnaires and surveys are done prior to the first yoga session and after the last yoga session. The yoga sessions are created with both the study participant and a certified yoga instructor. The patients are given the yoga routine to practice at home at their leisure.

Keywords

Eligibility

Minimum Age: 8 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Connecticut Children's Medical Center, Hartford, Connecticut, United States

Contact Details

Name: Andrea Orsey, MD

Affiliation: Connecticut Childrens Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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