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

Connecticut Children's Medical Center

Status: Completed

Conditions: Neoplasms

Treatments: Other: Yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT02899117

Pilot Yoga 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Yoga intervention

Experimental group

Description:

Patients in the yoga intervention group will have 4 yoga sessions with a certified yoga instructor while they are in the cancer clinic or on the inpatient floor.

Treatment:

Other: Yoga