Neoplasms
Conditions
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.
Interventions
OTHERYoga
There are 4 yoga sessions completed with a certified instructor during cancer treatment
Sponsors
Connecticut Children's Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of yoga intervention, assessed by institutional commitment of resources. | Assessments are collected at baseline and 8 weeks post baseline visit | Data will be reviewed for institutional resource commitment |
| Assess level of interest utlizing data from the Yoga satisfaction survey | 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. |
| Feasibility of yoga intervention, assessed by study accrual rates | Baseline and 8 weeks post baseline visit | Data will be assessed by accrual rates |
| Feasibility of yoga intervention, assessed by study visit attendance | Baseline and 8 weeks post baseline visit | Data will be assessed by study visit attendance |
| Feasibility of yoga intervention, assessed by study patient retention | Baseline and 8 weeks post baseline visit | Data will be assessed by the number of patients who remain in the study |
| Feasibility of yoga intervention, assessed by institutional support | Baseline and 8 weeks post baseline visit | Data will be reviewed for evidence of institutional support |
| Feasibility of yoga intervention, perceived barriers/solutions | Change from baseline barriers/solutions at 8 weeks post baseline visit | The data will be assessed on perceived barriers/solutions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in quality of life Patient | 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. |
| Improvement in fatigue of Patient | 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. |
| Improvement in quality of life of Parent | Assessments are collected at baseline and 8 weeks post baseline visit | Parent quality of life will be assessed by the SF-12. |
| Improvement in caregiver burden of Parent. | Assessments are collected at baseline and 8 weeks post baseline visit | Caregiver burden will be assessed by the Zarit Caregiver Burden Index |
| Improvement in sleep of Patient | Assessments are collected at baseline and 8 weeks post baseline visit | Sleep will be assessed via diary of sleep and actigraphy |
Countries
United States
Outcome results
None listed