AnxietyNCT01939210

Meditation-Based Breathing Training in Improving Target Motion Management and Reducing Distress in Patients With Abdominal or Lung Cancer Undergoing Radiation Therapy

A study testing Educational Intervention, Meditation Therapy and Questionnaire Administration in people with Anxiety and Depression, run by Albert Einstein College of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety, Depression, Digestive System Neoplasm
What is being tested?: Educational Intervention, Meditation Therapy and Questionnaire Administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Feb 2010to 2 Dec 2015
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

PHASE I - PATIENTS: All patients with abdominal tumors who have undergone at least 4 respiratory-gated radiotherapy treatments
PHASE I - PATIENTS: Full comprehension of English language
PHASE I - STAFF: All staff who have overseen the delivery of respiratory-gated radiotherapy for at least 6 months
PHASE I - STAFF: Full comprehension of English language
PHASE II: All patients with abdominal or lung tumors undergoing a respiratory gating simulation
PHASE II: Karnofsky performance status > 60%

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PHASE II: Life expectancy > 3 months
PHASE II: No prior radiotherapy to the abdomen/lung
PHASE II: Full comprehension of English language

Who cannot join

PHASE I - PATIENTS: Inability to comprehend English language interview questions
PHASE I - STAFF: Inability to comprehend English language interview questions
PHASE II: Karnofsky performance status < 60%
PHASE II: Prior radiotherapy to the abdomen/lung
PHASE II: Evidence of progressive or untreated gross disease outside of the abdomen/lung
PHASE II: Inability to comprehend English language breathing exercise instructions
PHASE II: Concurrent diagnosis of a significant respiratory disorder which requires the use of oxygen

Trial locations and contacts

1 site in 1 country.

United States1 site

Albert Einstein College of Medicine
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies

This randomized pilot clinical trial studies the effects of meditation-based breathing training on patients' control of their breathing patterns and breathing-related movement, as well as on their psychological distress and treatment experience during radiation therapy. Meditation-based breathing training may decrease breathing-related movement and the amount of stress by improving breathing patterns in patients with abdominal or lung cancer undergoing radiation therapy.

Read the detailed description

PRIMARY OBJECTIVES:

To evaluate the influence of regular breathing cycles using breathing relaxation techniques on efficacy of the respiratory-gated treatment as measured by: (1) real-time position management (RPM) parameters; (2) end inspiration or expiration length; (3) changes in gate width.

SECONDARY OBJECTIVES:

To evaluate the effect of breathing relaxation techniques on: (1) psychosocial outcomes; (2) treatment compliance.

OUTLINE:

PHASE I: Patients and staff members complete structured interviews at baseline.

PHASE II: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in 3 50-minute breathing training sessions, including a psycho-educational component and meditation-based breathing training, over 10 days. Patients then undergo four dimensional computed tomography (4D-CT) on day 14 and undergo image-guided stereotactic body radiation therapy (SBRT) or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.

ARM II: Patients receive standard care over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.

After completion of study treatment, patients are followed up at 2 or 5 weeks.

Conditions: Anxiety, Depression, Digestive System Neoplasm, Lung Neoplasm, Pain, Post-Traumatic Stress Disorder
Being tested: Educational Intervention, Meditation Therapy, Questionnaire Administration
Medical subject headings: Anxiety Disorders, Depression, Digestive System Neoplasms, Lung Neoplasms, Pain, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Educational InterventionOther
Also called Education for Intervention, Intervention, Educational
Participate in breathing training sessions
Meditation TherapyOther
Also called Meditation
Participate in breathing training sessions
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT01939210
Study group	Role	What they receive
Arm I (breathing training sessions)	Experimental	Patients participate in 3 50-minute breathing training sessions, including a psycho-educational component and meditation-based breathing training, over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively. Receives: Other: Educational Intervention; Other: Meditation Therapy; Other: Questionnaire Administration
Arm II (control)	Active comparator	Patients receive standard care over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively. Receives: Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in duty cycle, defined as the fraction of the time of the breathing cycle that the beam is on, before and after breath coaching
Data will be analyzed using a mixed-model analysis of variance (ANOVA) to test for differences between the two independent groups (with a fixed effect factor of group membership).
Measured: Baseline to up to 5 weeks
Changes in gate width
Measured: Baseline to up to 5 weeks
Changes in the length of the end expiration or end inspiration defined as when the breathing trace or internal motion change direction
Data will be analyzed using a mixed-model ANOVA to test for differences between the two independent groups (with a fixed effect factor of group membership).
Measured: Baseline to up to 5 weeks

Secondary outcomes (1)

Change in patients' self-reported levels of psychological distress, physical pain and discomfort, and post-traumatic stress associated with cancer diagnosis and radiation treatment
Data will be analyzed using a mixed-model ANOVA to test for differences between the two independent groups (with a fixed effect factor of group membership).
Measured: Baseline to up to 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 20102 Dec 2015

First posted11 Sep 2013 (estimated)
Study startFeb 2010
Primary completionJun 2015
Study completion2 Dec 2015

Why it stopped: lack of funding to hire a dedicated study interventionist

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnxietyStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01939210
Sponsor's protocol ID: 09-12-392
Other IDs: NCI-2013-01127, 09-068, 09-12-392, P30CA013330
Status last verified: May 2018
First submitted: 6 Sep 2013
Last updated: 18 May 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies
ClinicalTrials.gov ID: NCT01939210
Acronym / sponsor ID: 09-12-392
Conditions: Anxiety, Depression, Digestive System Neoplasm, Lung Neoplasm, Pain, Post-Traumatic Stress Disorder
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of funding to hire a dedicated study interventionist
Enrolment: 17 participants (actual)
Lead sponsor: Albert Einstein College of MedicineUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Feb 2010
Primary completion: Jun 2015 (actual)
Study completion: 2 Dec 2015 (actual)
First posted: 11 Sep 2013 (estimated)
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.

Detailed description

PRIMARY OBJECTIVES:

To evaluate the influence of regular breathing cycles using breathing relaxation techniques on efficacy of the respiratory-gated treatment as measured by: (1) real-time position management (RPM) parameters; (2) end inspiration or expiration length; (3) changes in gate width.

SECONDARY OBJECTIVES:

To evaluate the effect of breathing relaxation techniques on: (1) psychosocial outcomes; (2) treatment compliance.

OUTLINE:

PHASE I: Patients and staff members complete structured interviews at baseline.

PHASE II: Patients are randomized to 1 of 2 arms.

After completion of study treatment, patients are followed up at 2 or 5 weeks.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (breathing training sessions)	Experimental	Other: Educational Intervention, Other: Meditation Therapy, Other: Questionnaire AdministrationPatients participate in 3 50-minute breathing training sessions, including a psycho-educational component and meditation-based breathing training, over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.
Arm II (control)	Active comparator	Other: Questionnaire AdministrationPatients receive standard care over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

PHASE I - PATIENTS: All patients with abdominal tumors who have undergone at least 4 respiratory-gated radiotherapy treatments
PHASE I - PATIENTS: Full comprehension of English language
PHASE I - STAFF: All staff who have overseen the delivery of respiratory-gated radiotherapy for at least 6 months
PHASE I - STAFF: Full comprehension of English language
PHASE II: All patients with abdominal or lung tumors undergoing a respiratory gating simulation

Key exclusion criteria (7 listed)

PHASE I - PATIENTS: Inability to comprehend English language interview questions
PHASE I - STAFF: Inability to comprehend English language interview questions
PHASE II: Karnofsky performance status < 60%
PHASE II: Prior radiotherapy to the abdomen/lung
PHASE II: Evidence of progressive or untreated gross disease outside of the abdomen/lung

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
Educational InterventionAlso: Education for Intervention, Intervention, EducationalParticipate in breathing training sessions	Other	Arm I (breathing training sessions)
Meditation TherapyAlso: MeditationParticipate in breathing training sessions	Other	Arm I (breathing training sessions)
Questionnaire AdministrationAncillary studies	Other	Arm I (breathing training sessions), Arm II (control)

Primary outcome

Change in duty cycle, defined as the fraction of the time of the breathing cycle that the beam is on, before and after breath coaching
Time frame: Baseline to up to 5 weeks
Data will be analyzed using a mixed-model analysis of variance (ANOVA) to test for differences between the two independent groups (with a fixed effect factor of group membership).
Changes in gate width
Time frame: Baseline to up to 5 weeks
Changes in the length of the end expiration or end inspiration defined as when the breathing trace or internal motion change direction
Time frame: Baseline to up to 5 weeks
Data will be analyzed using a mixed-model ANOVA to test for differences between the two independent groups (with a fixed effect factor of group membership).

1 secondary outcome

Change in patients' self-reported levels of psychological distress, physical pain and discomfort, and post-traumatic stress associated with cancer diagnosis and radiation treatment
Time frame: Baseline to up to 5 weeks

Results and safety

The study was stopped early (reason given: lack of funding to hire a dedicated study interventionist). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.

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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.

Alyson Moadel principal investigator

Albert Einstein College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 May 2018. 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 stopped early (reason given: lack of funding to hire a dedicated study interventionist). Results are not available in the source record.

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?

Change in duty cycle, defined as the fraction of the time of the breathing cycle that the beam is on, before and after breath coaching (time frame: Baseline to up to 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01939210.

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 18 May 2018.