This clinical trial studies how well guided meditation works in reducing anxiety during radiation therapy for patients with breast and gynecological cancers. Anxiety and distress are all well-known symptoms in patients with cancer undergoing treatment. Guided meditation (a mindfulness-based intervention) consists of five different mindfulness practices: 1) Body Scan practice, in which patients are instructed to direct non-judgmental attention to different regions of the body; 2) Mindful Breathing practice, in which patients are instructed to focus attention on the breath and to accept distracting thoughts, negative emotions, and body sensations; 3) Mindfulness of Discomfort practice, in which patients are instructed to “zoom in” to deconstruct emotional/physical discomfort to each feelings’ spatial location, use mindful breathing to “zoom out”, and to shift attention from unpleasant feelings to neutral/pleasant sensations or experiences; 4) Savoring practice, in which patients are instructed to identify and amplify pleasant memories; and 5) Loving-Kindness practice, in which patients are instructed to cultivate feelings of warmth and compassion toward the self and others. This guided meditation intervention may be effective in reducing the stress and anxiety that patients may experience during their radiation treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07166042.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Lindsay M. Burt
Phone: 801-585-0255
PRIMARY OBJECTIVE:
I. To assess the acute anxiolytic effects of a brief mindfulness intervention during radiation therapy (RT) for patients with anxiety related to RT for breast and gynecological cancers.
SECONDARY OBJECTIVES:
I. To assess the distal anxiolytic effects of a brief mindfulness intervention during RT for patients with anxiety related to RT for breast and gynecological cancers.
II. To determine whether the brief mindfulness intervention during RT increases patients’ state mindfulness and whether the degree of changes in state mindfulness during RT predict decreases in acute anxiety and anxiety in daily life.
III. To determine whether the brief mindfulness intervention during RT increases patients’ self transcendence and whether the degree of changes in self transcendence during RT predict decreases in anxiety in daily life.
EXPLORATORY OBJECTIVE:
I. To assess the change in quality of life, anxiety and depression between the experimental and control arm over an extended time period using the World Health Organization Quality of Life (WHOQOL)-2, Generalized Anxiety Disorder 2-item scale (GAD-2) and Patient Health Questionnaire 2 (PHQ-2).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients listen to audio-recorded guided meditation followed by peaceful music over 10-15 minutes during each standard of care (SOC) RT session, 5 days per week for approximately 7 weeks.
ARM 2: Patients are allowed to listen to anything they choose during each SOC RT session, 5 days per week for approximately 7 weeks.
After completion of study intervention, patients are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorLindsay M. Burt
