Clinical trial NCT02899117: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 23
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Parents and children (ages 8-18) undergoing treatment (chemotherapy and/or radiation therapy) for cancer.
* Cancer diagnosis, between the ages of 8-18 year, English speaking, and medically cleared to participate in yoga.
* Parents will be eligible if they are over 18 years old, English speaking, and physically able to participate in yoga.

Exclusion Criteria:

* Children and parents not meeting inclusion criteria

Primary outcomes:
measure: Feasibility of yoga intervention, perceived barriers/solutions
timeFrame: Change from baseline barriers/solutions at 8 weeks post baseline visit
measure: Assess level of interest utlizing data from the Yoga satisfaction survey
timeFrame: Data collected at baseline and 8 weeks post baseline visit
measure: Feasibility of yoga intervention, assessed by study accrual rates
timeFrame: Baseline and 8 weeks post baseline visit
measure: Feasibility of yoga intervention, assessed by study visit attendance
timeFrame: Baseline and 8 weeks post baseline visit
measure: Feasibility of yoga intervention, assessed by study patient retention
timeFrame: Baseline and 8 weeks post baseline visit
measure: Feasibility of yoga intervention, assessed by institutional support
timeFrame: Baseline and 8 weeks post baseline visit
measure: Feasibility of yoga intervention, assessed by institutional commitment of resources.
timeFrame: Assessments are collected at baseline and 8 weeks post baseline visit
Secondary outcomes:
measure: Improvement in sleep of Patient
timeFrame: Assessments are collected at baseline and 8 weeks post baseline visit
measure: Improvement in quality of life Patient
timeFrame: Assessments are collected at baseline and 8 weeks post baseline visit
measure: Improvement in fatigue of Patient
timeFrame: Assessments are collected at baseline and 8 weeks post baseline visit
measure: Improvement in quality of life of Parent
timeFrame: Assessments are collected at baseline and 8 weeks post baseline visit
measure: Improvement in caregiver burden of Parent.
timeFrame: Assessments are collected at baseline and 8 weeks post baseline visit
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Childrens Medical Center
name: Andrea Orsey, MD
role: PRINCIPAL_INVESTIGATOR
References: