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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01476891
Recruitment Status : Unknown
Verified January 2013 by AHS Cancer Control Alberta ( Alberta Health services ).
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2011
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by (Responsible Party):
AHS Cancer Control Alberta ( Alberta Health services )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mindfulness-Based Stress Reduction (MBSR) Cancer Other: Immediate MBSR Other: Wait-list Control Group. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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.
Study Start Date : January 2011
Estimated Primary Completion Date : August 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Wait-List
Wait-list Control Group. The control group will receive the next available online MBSR program.
 Other: Wait-list Control Group.
Wait-list Control Group. The control group will receive the next available online MBSR program.
Active Comparator: Immediate MBSR
Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.
 Other: Immediate MBSR
Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility [ Time Frame: 44 months ]
    recruitment, retention, attendance, adherence, satisfaction


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 44 months ]
    Profile of Mood States (POMS), Calgary Symptoms of Stress Inventory (C-SOSI)

  2. Post-Traumatic Growth Inventory (PTGI) [ Time Frame: 44 months ]
  3. Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) [ Time Frame: 44 months ]
  4. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 44 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476891


Locations
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Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health services
Tom Baker Cancer Centre
Investigators
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Principal Investigator: Linda Carlson, PhD University of Calgary, Tom Baker Cancer Centre
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alberta Health services
ClinicalTrials.gov Identifier: NCT01476891    
Other Study ID Numbers: eCALM
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013
Keywords provided by AHS Cancer Control Alberta ( Alberta Health services ):
MBSR
Cancer
Online
Mindfulness Meditation
Randomized Waitlist Controlled Trial