The eCALM Study - An Online Mindfulness-Based Stress Reduction Program for Individuals Living With Cancer in Alberta

Study Overview
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Brief Summary
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For people with cancer, in-person Mindfulness-Based Stress Reduction (MBSR) participation can decrease stress symptoms, mood disturbance, and fatigue, as well as enhance personal growth and spirituality, and improve quality of life and sleep. Online MBSR may improve the accessibility of MBSR programs to underserved cancer patients who are unable to attend available in-person groups. This study will examine whether patients are willing to participate and complete the program, and also whether the online program improves mood and stress.

Official Title
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The eCALM Study - eTherapy for Cancer Applying Mindfulness: Online Mindfulness-Based Stress Reduction Program for Underserved Cancer Patients in Alberta: A Randomized Wait-list Controlled Trial.

Conditions
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Mindfulness-Based Stress Reduction (MBSR), Cancer

Intervention / Treatment
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* Other: Immediate MBSR
* Other: Wait-list Control Group.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Speak and read English sufficiently to complete questionnaires Women and men who have been diagnosed with any type of cancer, at any time in the past with no restriction on tumor site Pre or post primary cancer treatment, up to having completed primary cancer treatment within the last 36 months Exhibiting moderate distress Willing to participate in the intervention requirements; able to participate in the intervention (2 hrs per week for 8 weeks and a full day online retreat) Internet access Resident of Alberta, who has limited access to in-person cancer-specific MBSR programs Exclusion Criteria: Presence of major self-reported psychiatric disorder not in remission, current substance abuse/dependence, and psychotic symptoms Previous participation in a MBSR program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wait-List<br>Wait-list Control Group. The control group will receive the next available online MBSR program. | Other: Wait-list Control Group.<br>* Wait-list Control Group. The control group will receive the next available online MBSR program.<br>|
| Active Comparator: Immediate MBSR<br>Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program. | Other: Immediate MBSR<br>* Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | recruitment, retention, attendance, adherence, satisfaction | 44 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Profile of Mood States (POMS), Calgary Symptoms of Stress Inventory (C-SOSI) | 44 months | 
| Post-Traumatic Growth Inventory (PTGI) |  | 44 months | 
| Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) |  | 44 months | 
| Five Facet Mindfulness Questionnaire (FFMQ) |  | 44 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MBSR, Cancer, Online, Mindfulness Meditation, Randomized Waitlist Controlled Trial