Relaxation Therapy in Pediatric Oncology

NCT04719416 | Withdrawn

• 1 other identifier: 2020-1017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer

Keywords

pediatric cancer; relaxation therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improved sleep habits

  Measurement will be assessed through study completion, an average of 1 year

• Change in levels of pain

  Measurement will be assessed through study completion, an average of 1 year

Study Arms (4)

Active Treatment with Relaxation

ACTIVE COMPARATOR

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

Remission with Relaxation

ACTIVE COMPARATOR

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

Active Treatment without

NO INTERVENTION

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.

Remission without

NO INTERVENTION

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.

Interventions

Guided Meditation BEHAVIORAL

Approximately 10 minute recording of guided meditation focuses on muscle relaxation.

Active Treatment with Relaxation; Remission with Relaxation

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Santisree Tanikella, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Pediatrics

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: September 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)