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

NCT ID: NCT02899117

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-01-31

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Yoga intervention

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.

Group Type: EXPERIMENTAL

Yoga

Intervention Type: OTHER

There are 4 yoga sessions completed with a certified instructor during cancer treatment

Interventions

Yoga

There are 4 yoga sessions completed with a certified instructor during cancer treatment

Intervention Type: OTHER

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Andrea Orsey

Assitant Professor Dept of Hematology Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Orsey, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Childrens Medical Center

Locations

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

Pilot Yoga 1

Identifier Type: -

Identifier Source: org_study_id