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Completed

NCT Number: NCT02899117

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

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.

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Key information

Conditions

Neoplasms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

yoga

Other

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

Primary outcomes

  1. Feasibility of yoga intervention, perceived barriers/solutions

    Time frame: Change from baseline barriers/solutions at 8 weeks post baseline visit

    The data will be assessed on perceived barriers/solutions.

  2. Assess level of interest utlizing data from the Yoga satisfaction survey

    Time frame: Data collected at baseline and 8 weeks post baseline visit

    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.

  3. Feasibility of yoga intervention, assessed by study accrual rates

    Time frame: Baseline and 8 weeks post baseline visit

    Data will be assessed by accrual rates

  4. Feasibility of yoga intervention, assessed by study visit attendance

    Time frame: Baseline and 8 weeks post baseline visit

    Data will be assessed by study visit attendance

  5. Feasibility of yoga intervention, assessed by study patient retention

    Time frame: Baseline and 8 weeks post baseline visit

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

  6. Feasibility of yoga intervention, assessed by institutional support

    Time frame: Baseline and 8 weeks post baseline visit

    Data will be reviewed for evidence of institutional support

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

    Time frame: Assessments are collected at baseline and 8 weeks post baseline visit

    Data will be reviewed for institutional resource commitment

Secondary outcomes

  1. Improvement in sleep of Patient

    Time frame: Assessments are collected at baseline and 8 weeks post baseline visit

    Sleep will be assessed via diary of sleep and actigraphy

  2. Improvement in quality of life Patient

    Time frame: Assessments are collected at baseline and 8 weeks post baseline visit

    Quality of life will be assessed by PedsQL 4.0 and PedsQL 3.0 Cancer Module.

  3. Improvement in fatigue of Patient

    Time frame: Assessments are collected at baseline and 8 weeks post baseline visit

    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.

  4. Improvement in quality of life of Parent

    Time frame: Assessments are collected at baseline and 8 weeks post baseline visit

    Parent quality of life will be assessed by the SF-12.

  5. Improvement in caregiver burden of Parent.

    Time frame: Assessments are collected at baseline and 8 weeks post baseline visit

    Caregiver burden will be assessed by the Zarit Caregiver Burden Index

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 14, 2016
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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