A Mindfulness-Based Stress Reduction Program for Improving Mental Health Outcomes for Underserved Cancer Patients in Minnesota

A Pilot Study of Mindfulness-Based Stress Reduction (MBSR) in Patients With Cancer Experiencing Stress Who Live in Underserved and Rural Regions of Minnesota

This clinical trial evaluates whether a virtual stress reduction program that uses mindfulness-based stress reduction (MBSR) techniques works to improve mental health outcomes in cancer patients living in underserved/rural regions of Minnesota. 80% of Minnesota counties are considered mental health care shortage areas. This shortage disproportionately impacts Minnesotans living in underserved and rural regions as they have to travel further for mental health care services. Interventions that provide patients with mental health resources from the comfort of their own home help to reduce barriers that limit access to mental health care. MBSR courses can help patients control their responses to stressful events, reduce the impact of chronic stress, develop more effective ways to cope with medical/psychological conditions, and increase overall sense of well-being. MBSR courses may serve as a way to bridge the gap between mental health care and patients with cancer living in underserved/rural regions of Minnesota.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Electronic Health Record Review; Behavioral: Mindfulness Relaxation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Stacy D. D'Andre
      • Contact: Stacy D. D'Andre; Phone Number: 507-284-2511

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a history of cancer, or currently have cancer
• Patients reporting > 4/10 emotional distress on a 0-10 scale within the past two weeks
• Have a computer or smartphone
• Willing to complete questionnaires

Exclusion Criteria:

• Non-English-speaking patients
• Life expectancy < 12 months
• Active psychiatric disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (MBSR); Patients participate in MBSR sessions weekly for 8 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Behavioral: Mindfulness Relaxation; Receive MBSR intervention; Other Names: MBSR; Mindfulness-Based Stress Reduction; Mindfulness Meditation; Mindful Meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rate	Assessed by the number of participants who complete the virtual stress reduction program (MBSR) program	Up to 10 weeks
Change in Stress	Assessed using the 10-item Perceived Stress Scale (PSS), which measures global perceived stress experienced by the participant over the preceding 30 days. The PSS consists of 10 questions assessing how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).	Baseline, at completion of 8-week course, 3 months, 6 months
Change in Anxiety	Assessed using the General Anxiety Disorder 7-item (GAD-7) scale. The GAD-7 consists of 7 questions answered on a scale of 0-3 where 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every days. The total score ranges from 0 to 21 where 0 indicates no anxiety, 1-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.	Baseline, at completion of 8-week course, 3 months, 6 months
Change in Mindfulness	Assessed using the Mindful Attention Awareness Scale (MAAS), a 15-item scale designed to assess a core characteristic of dispositional mindfulness (open or receptive awareness of and attention to what is taking place in the present). The MAAS consists of 15 statements about everyday experience, with each item answered on a scale ranging from 1 (almost always) to 6 (almost never) to indicate how frequently or infrequently participants have each experience. The MAAS is scored by computing a mean (average) of all 15 items. Higher scores reflect higher levels of dispositional mindfulness.	Baseline, at completion of 8-week course, 3 months, 6 months
Barriers to completion of the course	Assessed using a study-specific questionnaire. Responses will be evaluated and reported descriptively.	10 weeks post course enrollment

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Stacy D D'Andre, Mayo Clinic in Rochester

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2029

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: 24-013451 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2025-08924 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No