Using Meditation for Oncology Anxiety

NCT04312191 | Withdrawn

• 1 other identifier: 2019-0958
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• General Anxiety Disorder-7 scale (GAD-7)

  Validated tool to assess anxiety

  Change from Baseline GAD-7 at Week 6

• Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P)

  Validated measure of QOL in prostate cancer patients

  Change from Baseline FACT-P at Week 6

Secondary Outcomes (2)

• Meditation Log

  From Session 1 through Session 6 (6 weeks)

• Telephone Follow-up

  four weeks following study completion

Study Arms (2)

Control Group

NO INTERVENTION

The Control Group participants (Group A) will be initiating radiation therapy and receiving only standard of care therapy per their Radiation Oncologist.

Test Group

EXPERIMENTAL

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.

Other: Mantra Meditation

Interventions

Mantra Meditation OTHER

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.

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mellar Davis MD: lead
• Geisinger Clinic: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mellar Davis, 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: SPONSOR INVESTIGATOR
• PI Title: Staff Physician Palliative Care

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 18, 2020
• Study Start: January 31, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10