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Recruiting NCT07291011

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

No phase Interventional Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electronic Health Record Review, Mindfulness Relaxation, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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]
  • Change in Stress [Time frame: Baseline, at course completion (week 10), 3 months, 6 months]
  • Change in Anxiety [Time frame: Baseline, at course completion (week 10), 3 months, 6 months]
  • Change in Mindfulness [Time frame: Baseline, at course completion (week 10), 3 months, 6 months]
  • Barriers to completion of the course [Time frame: At course completion (week 10)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07291011 · 24-013451

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗