8-week mindfulness based stress reduction program

patients who have to wait before entering the MBSR program or who do not want to follow this program

mindfulness based stress reduction program

Christiaan Schotte, PhD

The main purpose of this study is to evaluate the effects of the Mindfulness Based Stress Reduction (MBSR) training program that is offered in the investigator hospital, more specifically on quality of life, coping strategies and partner relationship by using questionnaires. To asses the possible impact of this treatment on the latter domain, partners of the patients with a cancer diagnosis are invited to join the training program.

Patients with breast cancer often experience anxiety, depression, stress and reduced quality of life. As such, there is an increased interest in the implementation of the Mindfulness-Based Stress Reduction program as an additional supportive treatment. MBSR is a structured group program that aims at reducing stress levels by enhancing awareness of the present moment in combination with a non-judgemental attitude.

The study evaluates the effects of an 8-week MBSR program on quality of life, mood, depression, stress and coping skills in breast cancer patients.

Breast cancer patients of the Breast Clinic of the Universitair Ziekenhuis Brussel participate in the MBSR program. Before and after the training program patients filled out questionnaires evaluating quality of life, coping skills, emotional functioning, stress and aspects of mindfulness.

Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners

Belgian Federal Public Service, Food Chain Safety and Environment

Professor

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Participants will attend online group class/week for eight consecutive weeks. The MBSR will be based on the program adapted by the Multidisciplinary Pain Centre at Rigshospitalet (DK), which is tailored to patients with chronic pain. Each session has duration of 1.5 hours. Content is composed by meditation techniques and physical exercises, which focus on increasing awareness and acceptance of moment-to-moment experiences, including physical discomfort and difficult emotions.Two groups of 11-12 patients will be composed. However, individual meetings may be organized if the recruitment process shows difficulties to gather patients in groups. It will be delivered by a certified MBSR therapist and via Teams platform.

VRPS is based on four evidence-based principles of cognitive-behavioral therapy and pain neuroscience education. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules.The eight consecutive weeks program period of intervention is composed of one initial physical meeting with 1h duration to explain the basis/principles of the virtual tools offered, how the virtual appliance works and should be used, including safety recommendations as calm environment at home, sitting or lying position during use. Groups of maximum 13 patients will be organized. Patients will be instructed to use the equipment at least once a day and it can be used as many times as they wish per day aiming to reduce pain intensity or to avoid pain. Patients will also be asked to keep a diary to register the equipment use during the study period to secure the data.

Participants in the control group will not receive any of the interventions. This study will not interfere with medical treatment plan and patients from the three groups can receive other pain treatment prescribed by physician.

Online group class/week for eight consecutive weeks with 8 sessions

Online Mindfullness Based Stress Reduction Program

The VRPS has a variety of modules that can be used for pain management. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules. All modules were designed to minimize triggers of emotional distress or cybersickness.

Virtual Reality-based Pain Self-management program

Geana Kurita, PhD

Suzanne F Forsyth Herling, PhD

This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.

Considering the need of interventions to improve pain self-management to interrupt the "pain chronification" process and the indications regarding advantages of cognitive behavioral techniques and technologic resources, the purpose of this study is to test homebased interventions connecting these two areas. Here, the effects of an online delivered standardized mindfulness-based stress reduction program and non-pharmacological techniques delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more. Both interventions target primarily pain relief by providing pain regulating strategies.

The investigators will test the main hypothesis that participants assigned to Mindfulness-Based Stress Reduction (MBSR) or Virtual Reality-based Pain Self-management program (VRPS) present reduction of pain intensity among other outcomes at 2 months post-intervention as well as after 6-, 9-, and 12-months follow-up when compared to treatment as usual (control group).The primary aim is to investigate the effects of MBSR and VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-intervention.The secondary aims are to analyze the effects of both interventions on other patient-reported outcomes measures (PROMs), which are pain intensity at follow-ups, pain interference in daily activities, pain catastrophizing, pain acceptance, health-related quality of life, anxiety, depression, perceived change on over-all pain status, use of analgesic medication, and use of health care system among patients with non-cancer pain lasting 3 months or more. In addition, the effects of the two interventions will be compared.

This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): MBSR group, VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention.

The statistical analysis of the data will be blinded

Preventive Interventions for Chronic Pain Worsening

Satisfaction with the interventions will be asked to the intervention groups by general questions about the intervention experienced with answers in a 6-point scale (0=completely dissatisfied to 5= completely satisfied) and there will be space to write comments.

Pain intensity for worst pain in the last 24h: Brief Pain Inventory to measure pain intensity, from no pain (0) to worst pain ever (10)

Brief Pain Inventory to measure pain intensity from no pain (0) to worst pain ever (10) at follow-ups and interference on general activity, mood, walking ability, work, social relations, sleep, and enjoyment of life

Pain Catastrophizing Scale, using a 5-point Likert scale ranging from 0 (never) to 4 (always) to assess patterns of negative cognition and emotion in the context of actual or anticipated pain

Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score, using a rating scale from 0 to 6. Never true (0) to always true (6)

patient-generated outcome assessed by the Measure Yourself Medical Outcome Profile (MYMOP2), which measures effects from health care interventions on physical, emotional, or social symptoms/problems. It is problem-specific and includes general wellbeing

Physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health using the RAND 36-Item Short Form Health Survey version 1.0. First, precoded numeric values are recoded per the scoring key. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity. Measured on a rating scale,- "from not at all" (0) to "almost every day" (3)

Patient Health Questionnaires scale (PHQ-9) can help track a patient's overall depression severity as well as track the improvement of specific symptoms with treatment. Measured on a rating scale,- from "not at all" (0) to "almost every day" (3)

Medication used (type and quantity) The information collected will refer to the period from patient inclusion to up one year follow-up.

The number of times that he/she used the health care system because of his chronic pain problem and treatment received (pharmacologic, surgical, rehabilitation, etc.). The information collected will refer to the period from patient inclusion to up one year follow-up.

Number of absent days at work because of pain will be asked directly to the patients through the electronic forms. The information collected will refer to the period from patient inclusion to up one year follow-up.

The Novo Nordic Foundation

Rigshospitalet, Denmark

Behaviors and Mental Disorders

Quality of Life

In each session, three sections were discussed and reviewed: (1) last week's experiences, (2) training, and (3) practice. Each session usually began with mindfulness and meditation exercises, followed by group discussion, review of homework activities, and introduction to new exercises. Participants were asked to complete 15-30 minutes of daily practice each week.

No intervention will be applied to the control group.

Mindfulness Based Stress Reduction Program

Nihan Türkoğlu, Assist.Prof.

The participants consisted of 1332 caregivers of patients diagnosed with cancer, who applied to Atatürk University Health Research and Application Center, Outpatient Chemotherapy Unit between December 2022 and March 2023. In the power analysis, the sample of the research; According to Cohen, a total of 108 people, 54 of whom were in the experimental group and 54 in the control group, with a medium effect size of 0.5%, an error margin of 0.05% and a confidence interval of 0.95%, were 95% representative of the universe. Against the possibility of data loss, 20% backup sample was included in this number and the study was planned with a total of 124 people, 62 in the experimental group and 62 in the control group. 20 participants were excluded on the basis of inclusion and exclusion criteria. 104 participants formed the sample

Pretest measurements (T1) were made to the individuals in the experimental and control groups. 8-week mindfulness-based interventions were administered online to caregivers of cancer patients (Table 1). Before starting the MDI program in the experimental group, visual and written materials about the sessions prepared by the researchers were distributed. The program was implemented 4 days a week, 1 session a day, and each session was implemented in groups of 10-15 people for 60-90 minutes. After the 8-week MDI Program of the experimental group was completed, the data collection forms were re-applied to the individuals in the experimental and control groups, and posttest-1 measurements (T2) were made. 4 weeks after the posttest-1 measurements, the posttest-2 measurements (T3) of the individuals in the experimental and control groups were performed.

Mindfulness-Based Reduction Stress Program

The Effect of Mindfulness Based Stress Reduction Program on Stress and Quality of Life in Family Caregivers of Patients With Cancer: Randomized Controlled Trial

The scale was developed by Robinson (1983) to measure the subjective care burden of caregivers and to quickly identify families with care concerns. Its Turkish adaptation was made by Uğur and Fadıloğlu (2006). The reliability coefficient of the scale was found to be 0.77. The scale consists of 13 items. The scoring of the scale is between 0-1. A score above 7 indicates the burden of care subjectively.

It was developed by Weitzner et al. to measure the quality of life of caregivers of cancer patients, including physical function, emotional function, family function, and social function. The total score of each sub-dimension and scale in the scale varies between 0 and 140. A higher score indicates a better quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners	NCT01074528	Cancer	mindfulness bas...	18 Years - 70 Years	Belgian Federal Public Service, Food Chain Safety and Environment
Preventive Interventions for Chronic Pain Worsening	NCT06351046	Chronic Non-Can...	Online Mindfull... Virtual Reality...	18 Years -	Rigshospitalet, Denmark
Mindfulness-Based Reduction Stress Program	NCT05831293	Cancer Caregiver Stres... Quality of Life	Mindfulness Bas...	18 Years - 70 Years	Ataturk University
Preventive Interventions for Chronic Pain Worsening	NCT06351046	Chronic Non-Can...	Online Mindfull... Virtual Reality...	18 Years -	Rigshospitalet, Denmark

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