Outpatient Yoga Study for Adolescents Receiving Chemotherapy
Condition: Pediatric Cancer; Quality of Life; Cancer, Treatment-Related; Psychological Distress; Yoga; Feasibility
MeSH terms: Neoplasms, Second Primary
Study type: Interventional

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.
    

Intervention name(s): Yoga Intervention
Intervention type(s): Other
Intervention description(s): 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 model: Single Group Assignment
Intervention model description: This is a feasibility study to determine if a yoga intervention can be delivered via to outpatients receiving chemotherapy.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer; Pediatric cancer; Yoga; Psychological distress; Outpatient chemotherapy