Overview

This trial is active, not recruiting.

Conditions mindfulness-based stress reduction (mbsr), cancer
Treatments immediate mbsr, wait-list control group.
Sponsor AHS Cancer Control Alberta
Collaborator Tom Baker Cancer Centre
Start date January 2011
End date August 2014
Trial size 64 participants
Trial identifier NCT01476891, eCALM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Wait-list Control Group. The control group will receive the next available online MBSR program.
wait-list control group.
Wait-list Control Group. The control group will receive the next available online MBSR program.
(Active Comparator)
Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.
immediate mbsr
Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.

Primary Outcomes

Measure
Feasibility
time frame: 44 months

Secondary Outcomes

Measure
Efficacy
time frame: 44 months
Post-Traumatic Growth Inventory (PTGI)
time frame: 44 months
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
time frame: 44 months
Five Facet Mindfulness Questionnaire (FFMQ)
time frame: 44 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Linda Carlson, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.