Pediatric CancerNCT04719416
Relaxation Therapy in Pediatric Oncology
A study testing Guided Meditation in people with Pediatric Cancer, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Guided Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2022to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Current patient at Geisinger Foss Clinic - oncology department with a diagnosis of cancer for more than 2 months prior to the study start
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Guided Meditation
- Keywords
- pediatric cancer, relaxation therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided MeditationBehavioural
Approximately 10 minute recording of guided meditation focuses on muscle relaxation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurement will be assessed through study completion, an average of 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: Measurement will be assessed through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startSep 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Other projects and needs of study personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santisree Tanikella, Geisinger Clinic
- Investigators
- Santisree Tanikella, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719416
- Sponsor's protocol ID
- 2020-1017
- Status last verified
- Sep 2022
- First submitted
- 15 Jan 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Guided Meditation on Patient Outlook and Symptom Management in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT04719416
- Acronym / sponsor ID
- 2020-1017
- Conditions
- Pediatric Cancer
- Keywords
- pediatric cancer, relaxation therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other projects and needs of study personnel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Treatment with Relaxation | Active comparator | Behavioral: Guided MeditationThis 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. |
| Remission with Relaxation | Active comparator | Behavioral: Guided MeditationThis 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. |
| 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. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Current patient at Geisinger Foss Clinic - oncology department with a diagnosis of cancer for more than 2 months prior to the study start
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided MeditationApproximately 10 minute recording of guided meditation focuses on muscle relaxation. | Behavioural | Active Treatment with Relaxation, Remission with Relaxation |
Primary outcome
Improved anxiety level
Time frame: Measurement will be assessed through study completion, an average of 1 year
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.
2 secondary outcomes
Improved sleep habits
Time frame: Measurement will be assessed through study completion, an average of 1 year
Change in levels of pain
Time frame: Measurement will be assessed through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santisree Tanikella, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Meditation in people with Pediatric Cancer, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved anxiety level (time frame: Measurement will be assessed through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.