NCT07291011 · Mayo Clinic
A Mindfulness-Based Stress Reduction Program for Improving Mental Health Outcomes for Underserved Cancer Patients in Minnesota
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Electronic Health Record Review
Ancillary studies
BEHAVIORAL
Mindfulness Relaxation
Receive MBSR intervention
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Completion Rate
Time frame: Up to 10 weeks
Assessed by the number of participants who complete the virtual stress reduction program (MBSR) program
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).
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations