Using Meditation for Oncology Anxiety

Not Applicable

Withdrawn

• Conditions: Prostate Cancer; Anxiety; Quality of Life; Prostate Cancer Recurrent
• Interventions: Other: Mantra Meditation

• Registration Number: NCT04312191
• Lead Sponsor: Mellar Davis MD

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.

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Study Start: 2025-01-31
• Primary Completion: 2026-01-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

1. Males age 18 years and older, at the time of signing the informed consent.
2. Diagnosis of prostate cancer, newly diagnosed or recurrent, scheduled to receive radiation therapy for a minimum of 6 treatments.
3. Participant is willing and able to comply with all protocol requirements and procedures.
4. Capable of giving signed informed consent.

Exclusion Criteria

1. Current treatment for anxiety with benzodiazepines.
2. 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.
3. Current use of meditation treatment or therapy.
4. Significant medical conditions which are likely to result in hospitalization during the study.
5. Any conditions which may interfere with the ability to receive and follow meditation instruction or answer questionnaires.
6. Impaired due to use of drugs or alcohol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Mantra Meditation	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.

Primary Outcome Measures

Name	Time	Method
General Anxiety Disorder-7 scale (GAD-7)	Change from Baseline GAD-7 at Week 6	Validated tool to assess anxiety
Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P)	Change from Baseline FACT-P at Week 6	Validated measure of QOL in prostate cancer patients

Secondary Outcome Measures

Name	Time	Method
Meditation Log	From Session 1 through Session 6 (6 weeks)	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	four weeks following study completion	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.