Mindfulness-Based Stress Reduction (MBSR)eCALMNCT01476891
The eCALM Study - An Online Mindfulness-Based Stress Reduction Program for Individuals Living With Cancer in Alberta
A study testing Immediate MBSR in people with Mindfulness-Based Stress Reduction (MBSR) and Cancer, run by Alberta Health services at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mindfulness-Based Stress Reduction (MBSR), Cancer
- What is being tested?
- Immediate MBSR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of major self-reported psychiatric disorder not in remission, current substance abuse/dependence, and psychotic symptoms
- Previous participation in a MBSR program
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Mindfulness-Based Stress Reduction (MBSR), Cancer
- Being tested
- Immediate MBSR, Wait-list Control Group.
- Keywords
- MBSR, Cancer, Online, Mindfulness Meditation, Randomized Waitlist Controlled Trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate MBSROther
Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.
Wait-list Control Group.Other
Wait-list Control Group. The control group will receive the next available online MBSR program.
| Study group | Role | What they receive |
|---|---|---|
| Wait-List | Active comparator | Wait-list Control Group. The control group will receive the next available online MBSR program. Receives: Other: Wait-list Control Group. |
| Immediate MBSR | Active comparator | Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program. Receives: Other: Immediate MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
recruitment, retention, attendance, adherence, satisfaction
Measured: 44 months
Secondary outcomes (4)
Efficacy
Profile of Mood States (POMS), Calgary Symptoms of Stress Inventory (C-SOSI)
Measured: 44 months
Post-Traumatic Growth Inventory (PTGI)
Measured: 44 months
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
Measured: 44 months
Five Facet Mindfulness Questionnaire (FFMQ)
Measured: 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mindfulness-Based Stress Reduction (MBSR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Linda Carlson, PhD, Principal investigator, University of Calgary, Tom Baker Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476891
- Sponsor's protocol ID
- eCALM
- Acronym
- eCALM
- Status last verified
- Jan 2013
- First submitted
- 16 Nov 2011
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24804884Zernicke 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.
PubMed 23414206
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01476891
- Acronym / sponsor ID
- eCALM / eCALM
- Conditions
- Mindfulness-Based Stress Reduction (MBSR), Cancer
- Keywords
- MBSR, Cancer, Online, Mindfulness Meditation, Randomized Waitlist Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (estimated)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-List | Active comparator | Other: Wait-list Control Group.Wait-list Control Group. The control group will receive the next available online MBSR program. |
| Immediate MBSR | Active comparator | Other: Immediate MBSRImmediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of major self-reported psychiatric disorder not in remission, current substance abuse/dependence, and psychotic symptoms
- Previous participation in a MBSR program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate MBSRImmediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program. | Other | Immediate MBSR |
| Wait-list Control Group.Wait-list Control Group. The control group will receive the next available online MBSR program. | Other | Wait-List |
Primary outcome
Feasibility
Time frame: 44 months
recruitment, retention, attendance, adherence, satisfaction
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Derived from this study: PubMed 24804884Zernicke 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.
- Derived from this study: PubMed 23414206Zernicke 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.
- Study WebsiteLink provided by the sponsor.
- Investigator WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Carlson, PhD principal investigator
University of Calgary, Tom Baker Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate MBSR in people with Mindfulness-Based Stress Reduction (MBSR) and Cancer, run by Alberta Health services at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 44 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01476891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.