Relaxation Therapy in Pediatric Oncology

Effects of Guided Meditation on Patient Outlook and Symptom Management in Pediatric Oncology Patients

This study will look at the use of relaxation therapy in children with cancer. The study will compared patients who are current receiving treatment for their cancer and those who are currently in remission. Patients will be asked to listen to a short audio recording twice a week prior to going to bed which will walk patients through a mediation session. Surveys will be distributed through parental emails on the first of each month for each child to complete for the duration of 12 months. It is anticipated that the use of relaxation therapy will help to improve anxiety and pain levels in this population.

Study Overview

• Status: Withdrawn
• Conditions: Pediatric Cancer
• Intervention / Treatment: Behavioral: Guided Meditation

Detailed Description

Rationale: The utilization of complementary therapies in the management of cancer have not been extensively studied in the pediatric population. Patients in active treatment and even those in remission may experience higher levels of anxiety and medical complications compared to their counterparts. Complementary therapies such as meditation have been found to improve symptoms and decrease anxiety and pain levels in adult oncology patients.

Objective: The goal of this study is to determine the impact of relaxation breathing with body scan techniques through the utilization of media clips on pediatric oncology patients' complications, hospitalizations, anxiety levels and outlook on diagnosis and treatment management.

Methods: A randomized non-blind control trial will be conducted in order to compare a control to a therapy intervention group. The therapy will consist of a video clip approximately 5 minutes in length. The clip will walk the patient through mindfulness in breathing along with muscle relaxation of each muscle group. This therapy is to be completed three times a week prior to falling asleep. Prior to initiation of therapy a baseline questionnaire will be completed. Following initiation, a follow up survey will be distributed on a monthly basis to assess for symptom severity, number of hospitalizations and patient outlook.

Population: The study population includes patients seen at Janet Weis Children's Hospital's pediatric oncology clinic. Patients must be in the age range of 6-20 years old for the entire year of the study in order to qualify. Exclusion criteria includes patients who are actively receiving drug therapy for anxiety or depression or receiving palliative care. Patients who pass away within the year of study will be excluded.

Time Frame: Following recruitment, each patient will be enrolled for the total of a one-year time frame.

Expected Outcomes: The investigators project that the patients utilizing guided meditation will experience decreased levels of anxiety, pain and complications compared to those of the control group.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current patient at Geisinger Foss Clinic - oncology department with a diagnosis of cancer for more than 2 months prior to the study start

Exclusion Criteria:

• Current use of any psychiatric medications including those for anxiety, depression or mood disorders
• Non-English speaking
• Patients receiving palliative care
• Patients with Langerhans' cell histiocytosis, benign teratomas and craniopharyngioma as they do not clearly constitute malignancy
• Patients with a history of cognitive developmental delay

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment with Relaxation; This subgroup comprises of patients who are currently receiving active treatment for their cancer diagnosis. They will be completing the pre-recorded relaxation audio therapy twice weekly prior to falling asleep.	Behavioral: Guided Meditation; Approximately 10 minute recording of guided meditation focuses on muscle relaxation.
Active Comparator: Remission with Relaxation; This subgroup comprises of patients who are currently in remission for their cancer diagnosis. They will be completing the pre-recorded relaxation audio therapy twice weekly prior to falling asleep.	Behavioral: Guided Meditation; Approximately 10 minute recording of guided meditation focuses on muscle relaxation.
No Intervention: Active Treatment without; This subgroup comprises of patients who are currently receiving active treatment for their cancer diagnosis. They will not be asked to complete any additional relaxation therapy.
No Intervention: Remission without; This subgroup comprises of patients who are currently in remission for their cancer diagnosis. They will not be asked to complete any additional relaxation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved anxiety level	Anxiety level will be measured through a series of monthly surveys asking patients to rate how often they experience worry over their diagnosis, school, have difficulty paying attention, feel angry, sad or alone as never, rarely, sometimes or often.	Measurement will be assessed through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved sleep habits	Sleep habits will be measured through a series of monthly surveys asking patients to rate how often they experience difficulty falling asleep, staying asleep and if they feel more tired than usual as yes or no.	Measurement will be assessed through study completion, an average of 1 year
Change in levels of pain	Levels of pain will be assessed through monthly surveys asking the patient to rate their overall pain level over the past month as 1-10 with 10 being a lot of pain.	Measurement will be assessed through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Santisree Tanikella, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pediatric cancer; relaxation therapy
• Other Study ID Numbers: 2020-1017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No