Clinical trial NCT01476891: The eCALM Study - An Online Mindfulness-Based Stress Reduction Program for Individuals Living With Cancer in Alberta
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mindfulness-Based Stress Reduction (MBSR)
Cancer
Keywords: MBSR
Cancer
Online
Mindfulness Meditation
Randomized Waitlist Controlled Trial
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Tom Baker Cancer Centre
First posted: 2011-11-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Feasibility
timeFrame: 44 months
Secondary outcomes:
measure: Efficacy
timeFrame: 44 months
measure: Post-Traumatic Growth Inventory (PTGI)
timeFrame: 44 months
measure: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
timeFrame: 44 months
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 44 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: University of Calgary, Tom Baker Cancer Centre
name: Linda Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zernicke KA, Campbell TS, Speca M, McCabe-Ruff K, Flowers S, Carlson LE. A randomized wait-list controlled trial of feasibility and efficacy of an online mindfulness-based cancer recovery program: the eTherapy for cancer applying mindfulness trial. Psychosom Med. 2014 May;76(4):257-67. doi: 10.1097/PSY.0000000000000053.
citation: Zernicke KA, Campbell TS, Speca M, McCabe-Ruff K, Flowers S, Dirkse DA, Carlson LE. The eCALM Trial-eTherapy for cancer appLying mindfulness: online mindfulness-based cancer recovery program for underserved individuals living with cancer in Alberta: protocol development for a randomized wait-list controlled clinical trial. BMC Complement Altern Med. 2013 Feb 16;13:34. doi: 10.1186/1472-6882-13-34.