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NCT Number: NCT07291011

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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Ahauve Oruse, MD, MPH

CONTACT

507-284-5162

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Stacy D. D'Andre

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 six months
  • Patients with a Rural-Urban Commuting Area (RUCA) code of 4 or greater
  • Have a computer or smartphone
  • Willing to complete questionnaires

Exclusion criteria

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

Treatment and study plan

Electronic Health Record Review

Other

Ancillary studies

Mindfulness Relaxation

Behavioral

Receive MBSR intervention

Other names: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Completion Rate

    Time frame: Up to 10 weeks

    Assessed by the number of participants who complete the virtual stress reduction program (MBSR) program

  2. Change in Stress

    Time frame: Baseline, at course completion (week 10), 3 months, 6 months

    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).

  3. Change in Anxiety

    Time frame: Baseline, at course completion (week 10), 3 months, 6 months

    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.

  4. Change in Mindfulness

    Time frame: Baseline, at course completion (week 10), 3 months, 6 months

    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.

  5. Barriers to completion of the course

    Time frame: At course completion (week 10)

    Assessed using a study-specific questionnaire. Responses will be evaluated and reported descriptively.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahauve Orusa, MD, MPH

CONTACT

507-284-5162

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 18, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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