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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01476891
First received: November 16, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Mindfulness-Based Stress Reduction (MBSR)
Cancer
 Other: Immediate MBSR
Other: Wait-list Control Group.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 44 months ] [ Designated as safety issue: No ]
    recruitment, retention, attendance, adherence, satisfaction


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 44 months ] [ Designated as safety issue: No ]
    Profile of Mood States (POMS), Calgary Symptoms of Stress Inventory (C-SOSI)

  • Post-Traumatic Growth Inventory (PTGI) [ Time Frame: 44 months ] [ Designated as safety issue: No ]
  • Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) [ Time Frame: 44 months ] [ Designated as safety issue: No ]
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 44 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: January 2011
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476891

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

Additional Information:
Study Website  This link exits the ClinicalTrials.gov site
Investigator Website  This link exits the ClinicalTrials.gov site

No publications provided by Alberta Health Services

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

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT01476891     History of Changes
Other Study ID Numbers: eCALM
Study First Received: November 16, 2011
Last Updated: January 17, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Alberta Health Services:
MBSR
Cancer
Online
Mindfulness Meditation
Randomized Waitlist Controlled Trial

ClinicalTrials.gov processed this record on May 23, 2013