Outpatient Yoga Study for Adolescents Receiving Chemotherapy

NCT ID: NCT03318068

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-02-13

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.

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.

Conditions

Pediatric Cancer; Quality of Life; Cancer, Treatment-Related; Psychological Distress; Yoga; Feasibility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Yoga intervention arm

The group will receive a weekly yoga session for the duration of 10 weeks. The yoga sessions will be delivered in person for 3 weeks during the intervention, coordinated with existing clinic visits. The other 7 sessions will be delivered via skype. The participant will be asked to fill out questionnaires during each of the three in-person yoga visits asking about psychological symptoms and quality of life.

Group Type: EXPERIMENTAL

Yoga Intervention

Intervention Type: OTHER

The yoga intervention will consist of a combination of yoga postures, gentle stretches, breathing techniques and relaxation. The sessions will be delivered one-on-one and will be adapted to accommodate the patients each day.

Interventions

Yoga Intervention

The yoga intervention will consist of a combination of yoga postures, gentle stretches, breathing techniques and relaxation. The sessions will be delivered one-on-one and will be adapted to accommodate the patients each day.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 10 to 18
• Receiving active cancer therapy within 21 days of enrollment and for the 10 weeks of the study
• Able to perform yoga at home (the yoga is modified at home so that it low impact exercises and fit the capabilities of the patient)
• Planned to be outpatients for more than 75 % of study

Exclusion Criteria

• Sarcoma patients with future planned surgical interventions (can be enrolled after surgery)
• Planned HSCT during the 10 week study period

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Oncology Group of Ontario

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Lillian Sung

Pediatric Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lillian Sung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Oncologist, Senior Scientist

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

Stein E, Rayar M, Krishnadev U, Gupta A, Hyslop S, Plenert E, Schechter-Finkelstein T, Sung L. A feasibility study examining the impact of yoga on psychosocial health and symptoms in pediatric outpatients receiving chemotherapy. Support Care Cancer. 2019 Oct;27(10):3769-3776. doi: 10.1007/s00520-019-04673-9. Epub 2019 Feb 2.

Reference Type: DERIVED

PMID: 30712097 (View on PubMed)

Other Identifiers

REB# 1000054681

Identifier Type: -

Identifier Source: org_study_id