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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899117
• Other study ID #: Pilot Yoga 1
• Status: Completed
• Phase: N/A
• First received: August 23, 2016
• Last updated: February 15, 2017
• Start date: August 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• Yoga
There are 4 yoga sessions completed with a certified instructor during cancer treatment

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Feasibility of yoga intervention, assessed by study accrual rates	Data will be assessed by accrual rates	Baseline and 8 weeks post baseline visit
Primary	Feasibility of yoga intervention, assessed by study visit attendance	Data will be assessed by study visit attendance	Baseline and 8 weeks post baseline visit
Primary	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
Primary	Feasibility of yoga intervention, assessed by institutional support	Data will be reviewed for evidence of institutional support	Baseline and 8 weeks post baseline visit
Primary	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	Improvement in sleep of Patient	Sleep will be assessed via diary of sleep and actigraphy	Assessments are collected at baseline and 8 weeks post baseline visit
Secondary	Improvement in quality of life Patient	Quality of life will be assessed by PedsQL 4.0 and PedsQL 3.0 Cancer Module.	Assessments are collected at baseline and 8 weeks post baseline visit
Secondary	Improvement in fatigue of Patient	Fatigue will be assessed by the Fatigue Scale (FS). The Fatigue Scale for children (FS-C) between 8-12 years and the Fatigue Scale for adolescent (FS-A) between 13-18 years.	Assessments are collected at baseline and 8 weeks post baseline visit
Secondary	Improvement in quality of life of Parent	Parent quality of life will be assessed by the SF-12.	Assessments are collected at baseline and 8 weeks post baseline visit
Secondary	Improvement in caregiver burden of Parent.	Caregiver burden will be assessed by the Zarit Caregiver Burden Index	Assessments are collected at baseline and 8 weeks post baseline visit