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

NCT07291011 | Recruiting

• 2 other identifiers: 24-013451NCI-2025-08924
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Supportive care (MBSR)

EXPERIMENTAL

Patients participate in MBSR sessions weekly for 8 weeks.

Other: Electronic Health Record Review; Behavioral: Mindfulness Relaxation; Other: Questionnaire Administration

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Supportive care (MBSR)

Mindfulness Relaxation BEHAVIORAL

Receive MBSR intervention

Also known as: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

Supportive care (MBSR)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (MBSR)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Mindfulness; Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stacy D D'Andre

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)