Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT03318068
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Yoga Study for Adolescents Receiving Chemotherapy
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
A Feasibility Study Examining the Impact of Out-patient Yoga on Children Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
LAY SUMMARY:
The diagnosis and treatment of pediatric cancer is a significant stressor for adolescents and their families . Although most adolescents cope well with their cancer diagnosis, many experience emotional distress. A small proportion of those diagnosed with cancer will experience more intense mental distress, such as depression, anxiety, or anger. The practice of yoga may be a possible way of treating the negative emotional symptoms experienced by these adolescents. Previous studies suggest that yoga may improve anxiety, mood and psychological distress in adults with cancer. The results of two recent pediatric pilot studies show that yoga programs improved quality of life for adolescents receiving cancer treatment. Given this, we wish to examine the feasibility of offering a 10-week yoga program for adolescents who are receiving outpatient chemotherapy. This program includes both one-on-one in-person sessions and home-based sessions offered using SkypeTM. To assess this program, we will monitor patients' attendance, ask their opinions of the program and evaluate whether yoga improved their mental well-being. This study represents an important step toward identifying possible treatments to improve patients' quality of life and emotional health.
The diagnosis and treatment of pediatric cancer is a significant stressor for adolescents and their families . Although most adolescents cope well with their cancer diagnosis, many experience emotional distress. A small proportion of those diagnosed with cancer will experience more intense mental distress, such as depression, anxiety, or anger. The practice of yoga may be a possible way of treating the negative emotional symptoms experienced by these adolescents. Previous studies suggest that yoga may improve anxiety, mood and psychological distress in adults with cancer. The results of two recent pediatric pilot studies show that yoga programs improved quality of life for adolescents receiving cancer treatment. Given this, we wish to examine the feasibility of offering a 10-week yoga program for adolescents who are receiving outpatient chemotherapy. This program includes both one-on-one in-person sessions and home-based sessions offered using SkypeTM. To assess this program, we will monitor patients' attendance, ask their opinions of the program and evaluate whether yoga improved their mental well-being. This study represents an important step toward identifying possible treatments to improve patients' quality of life and emotional health.
Detailed Description:
Background: The diagnosis and treatment of pediatric cancer is often a distressing time for patients and families. Moreover, a subset of patients experience significant negative psychological symptoms at time of diagnosis. Often times, these symptoms persist throughout treatment, and, possibly, for years after their diagnosis. Available evidence suggests that early identification and intervention for these psychological symptoms may reduce their short-term and long-term impact. Yoga has emerged as a potential therapeutic intervention to improve psychosocial wellness with promising preliminary results in adult cancer populations.
Objective: To determine the feasibility of a 10-week, weekly yoga intervention for adolescents with cancer currently receiving cancer therapy.
Methods: This pilot study will consist of 45-minute yoga sessions administered weekly for 10 (+/- 2) consecutive weeks. Three sessions will take place in-person, timed in conjunction with participants' clinic appointments, with the remainder of sessions administered at home, through SkypeTM. Each session will be one-to-one and conducted by a yoga instructor. Participants will also complete home exercises in between these weekly sessions. Adolescents ages 10 to 18 with any cancer diagnosis will be eligible for this study. Feasibility, the primary objective, will be determined by 1) the number of patients who are recruited for this study, and 2) the number of patients who in attend at least 60% of administered sessions. The feasibility, acceptability and utility of measuring participants' emotional distress and quality of life will be examined as secondary outcomes. These outcomes will be measured at baseline, mid-way and at the end of the intervention. The Patient Reported Outcomes Measurement Information System measures for anxiety, depression and anger will be used to measure emotional distress. Patient's fatigue and quality of life will be determined using the Pediatric Quality of Life Inventory Fatigue and Acute Cancer Modules. Study enrollment is planned at 10 participants, as this sample size will enable to assess if our intervention and measurements tool are appropriate.
Significance: This study represents an important first step in determining if yoga programs can be offered at home, and if such programs influence patient well-being. If feasible, outpatient yoga programs may offer a practical and cost-effective tool to provide enhanced psychosocial wellbeing among adolescents undergoing cancer therapy.
Objective: To determine the feasibility of a 10-week, weekly yoga intervention for adolescents with cancer currently receiving cancer therapy.
Methods: This pilot study will consist of 45-minute yoga sessions administered weekly for 10 (+/- 2) consecutive weeks. Three sessions will take place in-person, timed in conjunction with participants' clinic appointments, with the remainder of sessions administered at home, through SkypeTM. Each session will be one-to-one and conducted by a yoga instructor. Participants will also complete home exercises in between these weekly sessions. Adolescents ages 10 to 18 with any cancer diagnosis will be eligible for this study. Feasibility, the primary objective, will be determined by 1) the number of patients who are recruited for this study, and 2) the number of patients who in attend at least 60% of administered sessions. The feasibility, acceptability and utility of measuring participants' emotional distress and quality of life will be examined as secondary outcomes. These outcomes will be measured at baseline, mid-way and at the end of the intervention. The Patient Reported Outcomes Measurement Information System measures for anxiety, depression and anger will be used to measure emotional distress. Patient's fatigue and quality of life will be determined using the Pediatric Quality of Life Inventory Fatigue and Acute Cancer Modules. Study enrollment is planned at 10 participants, as this sample size will enable to assess if our intervention and measurements tool are appropriate.
Significance: This study represents an important first step in determining if yoga programs can be offered at home, and if such programs influence patient well-being. If feasible, outpatient yoga programs may offer a practical and cost-effective tool to provide enhanced psychosocial wellbeing among adolescents undergoing cancer therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: