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

NCT02899117 | Completed

• 1 other identifier: Pilot Yoga 1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (7)

• Feasibility of yoga intervention, perceived barriers/solutions

  The data will be assessed on perceived barriers/solutions.

  Change from baseline barriers/solutions at 8 weeks post baseline visit

• Assess level of interest utlizing data from the Yoga satisfaction survey

  Data will be assessed by level of interest utilizing data from the yoga satisfcation survey. Most responses will be on a Likert scale while some specific questions will be other formats (i.e. open ended questions). These questions will help to inform the intervention.

  Data collected at baseline and 8 weeks post baseline visit

• Feasibility of yoga intervention, assessed by study accrual rates

  Data will be assessed by accrual rates

  Baseline and 8 weeks post baseline visit

• Feasibility of yoga intervention, assessed by study visit attendance

  Data will be assessed by study visit attendance

  Baseline and 8 weeks post baseline visit

• Feasibility of yoga intervention, assessed by study patient retention

  Data will be assessed by the number of patients who remain in the study

  Baseline and 8 weeks post baseline visit

• Feasibility of yoga intervention, assessed by institutional support

  Data will be reviewed for evidence of institutional support

  Baseline and 8 weeks post baseline visit

• Feasibility of yoga intervention, assessed by institutional commitment of resources.

  Data will be reviewed for institutional resource commitment

  Assessments are collected at baseline and 8 weeks post baseline visit

Secondary Outcomes (5)

• Improvement in sleep of Patient

  Assessments are collected at baseline and 8 weeks post baseline visit

• Improvement in quality of life Patient

  Assessments are collected at baseline and 8 weeks post baseline visit

• Improvement in fatigue of Patient

  Assessments are collected at baseline and 8 weeks post baseline visit

• Improvement in quality of life of Parent

  Assessments are collected at baseline and 8 weeks post baseline visit

• Improvement in caregiver burden of Parent.

  Assessments are collected at baseline and 8 weeks post baseline visit

Study Arms (1)

Yoga intervention

EXPERIMENTAL

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.

Other: Yoga

Interventions

Yoga OTHER

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

Yoga intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Andrea Orsey, MD

  Connecticut Childrens Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor Dept of Hematology Oncology

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 14, 2016
• Study Start: August 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)