Guided Meditation During Radiotherapy.

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Radiation Toxicity; Quality of Life; Relaxation During Radiation Therapy; Cancer

Treatments: Other: Standard of Care; Behavioral: Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04303013

18-004546

NCI-2021-02757 (Registry Identifier)

Details and patient eligibility

About

The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment.

This study involves randomization. There is a 50 percent chance (like a flip of the coin) that you will be randomized to attend meditation sessions during treatment.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Prescribed a course of at least 15 daily fractions of RT for curative intent of any malignancy
• Willing to attend MBI sessions weekly during RT
• Able to transport themselves to scheduled MBI sessions in the DAHLC
• Able to complete questionnaire(s) by themselves
• Native English speaker (MBI sessions, videos, and QOL questionnaires are only available in English)
• ECOG Performance Status 0-2

Exclusion criteria

• Prescribed a course of RT with fewer than 15 consecutive, daily fractions
• Unable or unwilling to attend required MBI sessions

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

Standard of Care

Active Comparator group

Treatment:

Other: Standard of Care

Meditation

Experimental group

Treatment:

Behavioral: Meditation