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

Cancer Clinical Trial

— eCALM  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01476891
• Other study ID #: eCALM
• Status: Active, not recruiting
• Phase: N/A
• First received: November 16, 2011
• Last updated: January 17, 2013
• Start date: January 2011

Study information

• Verified date: January 2013
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Mindfulness-Based Stress Reduction (MBSR)

Intervention

Other:
• Immediate MBSR
Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.
• Wait-list Control Group.
Wait-list Control Group. The control group will receive the next available online MBSR program.

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Health Services	Tom Baker Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	recruitment, retention, attendance, adherence, satisfaction	44 months	No
Secondary	Efficacy	Profile of Mood States (POMS), Calgary Symptoms of Stress Inventory (C-SOSI)	44 months	No
Secondary	Post-Traumatic Growth Inventory (PTGI)		44 months	No
Secondary	Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)		44 months	No
Secondary	Five Facet Mindfulness Questionnaire (FFMQ)		44 months	No

External Links

•   Investigator Website