Using Meditation for Oncology Anxiety
Primary Purpose
Anxiety, Quality of Life, Prostate Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mantra Meditation
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Meditation with a Mantra, prostate cancer, radiation treatment, anxiety, quality of life, GAD-7, FACT-P
Eligibility Criteria
Inclusion Criteria:
- Males age 18 years and older, at the time of signing the informed consent.
- Diagnosis of prostate cancer, newly diagnosed or recurrent, scheduled to receive radiation therapy for a minimum of 6 treatments.
- Participant is willing and able to comply with all protocol requirements and procedures.
- Capable of giving signed informed consent.
Exclusion Criteria:
- Current treatment for anxiety with benzodiazepines.
- Current treatment for generalized anxiety disorder with an Selective Serotonin Reuptake Inhibitor(SSRI) or Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) initiated less than 6 weeks prior to enrollment in the study. Stable therapy for greater than 6 weeks prior to enrollment will be allowed.
- Current use of meditation treatment or therapy.
- Significant medical conditions which are likely to result in hospitalization during the study.
- Any conditions which may interfere with the ability to receive and follow meditation instruction or answer questionnaires.
- Impaired due to use of drugs or alcohol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Test Group
Arm Description
The Control Group participants (Group A) will be initiating radiation therapy and receiving only standard of care therapy per their Radiation Oncologist.
The Test Group participants (Group B) will be initiating radiation therapy and receiving standard of care therapy per their Radiation Oncologist. This group will also be taught mantra-based meditation to use during each radiation treatment session and encouraged to practice MM ad libitum outside of the treatment setting.
Outcomes
Primary Outcome Measures
General Anxiety Disorder-7 scale (GAD-7)
Validated tool to assess anxiety
Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P)
Validated measure of QOL in prostate cancer patients
Secondary Outcome Measures
Meditation Log
A blank log will be provided for the subjects to record the date and duration of the meditation sessions along with whether the meditation took place on a radiation treatment day and if the subject thought the meditation was helpful.
Telephone Follow-up
A one month follow up phone call will determine if the patients are continuing to use the MM and if they found the practice of MM useful not only in their radiation treatment sessions but in their everyday lives.
Full Information
NCT ID
NCT04312191
First Posted
March 4, 2020
Last Updated
May 17, 2023
Sponsor
Mellar Davis MD
Collaborators
Geisinger Clinic
1. Study Identification
Unique Protocol Identification Number
NCT04312191
Brief Title
Using Meditation for Oncology Anxiety
Official Title
Using Meditation to Treat Anxiety and Improve Quality of Life in Prostate Cancer Patients Receiving Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 31, 2024 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mellar Davis MD
Collaborators
Geisinger Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study is a prospective, interventional, randomized, treatment-controlled study, evaluating the use of Meditation with a Mantra (MM) to decrease anxiety levels and improve Quality of Life (QOL) in prostate cancer patients receiving radiation treatment. The study will be conducted across 6 radiation treatment sessions in men with newly diagnosed prostate cancer, Stage 1 to 3A, and men with recurrent prostate cancer. Patients will receive six radiation sessions with usual care with or without the addition of MM. MM Group patients will be given a log at the beginning of the study to record how long they are meditating and if they found meditation beneficial. The General Anxiety Disorder-7 scale (GAD-7) is a validated tool and will be used to assess anxiety in all participants. The Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P) is a validated measure of QOL in prostate cancer patients and will be used to assess QOL in all participants. A one month follow up phone call will determine if the patients are continuing to use the MM and if they found the practice of MM useful not only in their radiation treatment sessions but in their everyday lives.
Detailed Description
The current study is a prospective, interventional, randomized, treatment-controlled study, evaluating the use of MM to decrease anxiety levels and improve Quality of Life (QOL) in prostate cancer patients receiving radiation treatment. The study will be conducted across 6 radiation treatment sessions in men with newly diagnosed prostate cancer, Stage 1 to 3A, and men with recurrent prostate cancer. Approximately forty-six patients will be recruited to allow for forty patients to complete assessments. Twenty-three patients will receive six radiation sessions with MM and will be the Test Group. Twenty-three will receive usual care without MM and will be the Control Group. The Test Group will be taught how to meditate using a standard one-word mantra (Om). The first MM session would be a 30-minute introductory session prior to the first radiation treatment followed by five 20-minute sessions prior to each of the remaining five radiation treatments. The Control Group will receive radiation treatments without MM. During the five 20-minute sessions, the patients will receive a meditation refresher and reinforcement to continue to practice meditation at home. The teaching of MM during all sessions will be done by a dedicated research assistant with a Master of Science in Yoga Therapy. Test Group patients will be given a log at the beginning of the study to record how long they are meditating and if they found meditation beneficial. The General Anxiety Disorder-7 scale (GAD-7) is a validated tool and will be used to assess anxiety in all participants. The Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P) is a validated measure of QOL in prostate cancer patients and will be used to assess QOL in all participants. The GAD-7 and FACT-P will be assessed at baseline, radiation Session 3 and radiation Session 6 to determine the impact of MM on anxiety and QOL, respectively, in the Test Group compared to the Control Group. A one month follow up phone call will determine if the patients are continuing to use the MM and if they found the practice of MM useful not only in their radiation treatment sessions but in their everyday lives.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Quality of Life, Prostate Cancer, Prostate Cancer Recurrent
Keywords
Meditation with a Mantra, prostate cancer, radiation treatment, anxiety, quality of life, GAD-7, FACT-P
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 1:1 to standard of care only (Control Group) versus standard of care plus Meditation with a Mantra (MM) (Test Group) and will be followed for a total of 6 sessions of radiation therapy. Randomization will be executed using a computer-generated schema developed by the study biostatistician and stored in an electronic file.
The Test Group will be taught MM to use during each radiation treatment session and encouraged to practice MM ad libitum outside of the treatment setting.
For both the Control and Test Groups, validated questionnaires for anxiety and Quality Of Life will be administered at baseline, Session 3 and Session 6.
For the Test Group only, a log will be kept by the patient from Session 1 through follow-up, noting the times the MM is practiced. The Test Group will also receive a follow-up phone call on week 10 (one month after Session 6) to record whether the patient has continued to practice MM beyond the study requirements.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The Control Group participants (Group A) will be initiating radiation therapy and receiving only standard of care therapy per their Radiation Oncologist.
Arm Title
Test Group
Arm Type
Experimental
Arm Description
The Test Group participants (Group B) will be initiating radiation therapy and receiving standard of care therapy per their Radiation Oncologist. This group will also be taught mantra-based meditation to use during each radiation treatment session and encouraged to practice MM ad libitum outside of the treatment setting.
Intervention Type
Other
Intervention Name(s)
Mantra Meditation
Intervention Description
Mantra-based meditation will be taught using a standard one-word mantra (Om). Om is a non-English word that will help with focus as opposed to an English word which may cause distraction based on the word itself.
Primary Outcome Measure Information:
Title
General Anxiety Disorder-7 scale (GAD-7)
Description
Validated tool to assess anxiety
Time Frame
Change from Baseline GAD-7 at Week 6
Title
Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P)
Description
Validated measure of QOL in prostate cancer patients
Time Frame
Change from Baseline FACT-P at Week 6
Secondary Outcome Measure Information:
Title
Meditation Log
Description
A blank log will be provided for the subjects to record the date and duration of the meditation sessions along with whether the meditation took place on a radiation treatment day and if the subject thought the meditation was helpful.
Time Frame
From Session 1 through Session 6 (6 weeks)
Title
Telephone Follow-up
Description
A one month follow up phone call will determine if the patients are continuing to use the MM and if they found the practice of MM useful not only in their radiation treatment sessions but in their everyday lives.
Time Frame
four weeks following study completion
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males age 18 years and older, at the time of signing the informed consent.
Diagnosis of prostate cancer, newly diagnosed or recurrent, scheduled to receive radiation therapy for a minimum of 6 treatments.
Participant is willing and able to comply with all protocol requirements and procedures.
Capable of giving signed informed consent.
Exclusion Criteria:
Current treatment for anxiety with benzodiazepines.
Current treatment for generalized anxiety disorder with an Selective Serotonin Reuptake Inhibitor(SSRI) or Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) initiated less than 6 weeks prior to enrollment in the study. Stable therapy for greater than 6 weeks prior to enrollment will be allowed.
Current use of meditation treatment or therapy.
Significant medical conditions which are likely to result in hospitalization during the study.
Any conditions which may interfere with the ability to receive and follow meditation instruction or answer questionnaires.
Impaired due to use of drugs or alcohol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mellar Davis, MD
Phone
570-271-7383
Email
mdavis@geisinger.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary K Brigandi, DO
Phone
570-271-7383
Email
mbrigandi@geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mellar Davis, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Using Meditation for Oncology Anxiety
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