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

January 17, 2013 updated by: Alberta Health services

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health services

Collaborators

Tom Baker Cancer Centre

Investigators

  • Principal Investigator: Linda Carlson, PhD, University of Calgary, Tom Baker Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

November 16, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • eCALM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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