CancerI-CAN SLEEPNCT01335776
A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer
A study testing Mindfulness-Based Stress Reduction and Cognitive Behavior Therapy in people with Cancer and Insomnia, run by University of Calgary at 1 site in Canada.
Trial summary
Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Mindfulness-Based Stress Reduction and Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Jul 2012
- 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
- English speaking
- Non metastatic cancer
- 1 month post chemotherapy/radiation treatment (hormone treatment okay)
- Diagnosis of Primary or Secondary Insomnia
Who cannot join
- Presence of another sleep disorder
- Presence of another Axis I diagnosis (not in remission)
- Inability to attend at least 5 out of the 8 treatment sessions
- Randomization Refusal
- Previous participation in CBT-I or MBSR
- Shift work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Objective Comparison of Cognitive Behavioral Therapy and Mindfulness-based Stress Reduction for the Treatment of Insomnia in Cancer Survivors Using Wrist Actigraphy: A Randomized Noninferiority Trial
Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.
- Being tested
- Mindfulness-Based Stress Reduction, Cognitive Behavior Therapy
- Keywords
- Mindfulness-Based Stress Reduction, Cognitive Behavior Therapy, Actigraphy, Noninferiority, MBSR, CBT-I
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.
Cognitive Behavior TherapyBehavioural
Also called CBT-I
This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy | Experimental | Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation. Receives: Behavioral: Cognitive Behavior Therapy |
| Mindfulness-Based Stress Reduction | Experimental | The program consists of three primary components: theoretical material related to relaxation, meditation, and the mind-body connection; experiential practice of meditation and yoga and home based practice; group process focused on problem solving and support. Receives: Behavioral: Mindfulness-Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity from baseline to 3 months
Measured: Baseline, Post-Treatment, 3 month follow up
Secondary outcomes (6)
Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
Measured: Baseline, Post Treatment, 3 month follow up
Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months
Measured: Baseline (one week), During treatment (7 weeks), Post Treatment (1 week), 3 month Follow up (1 week)
Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months
Measured: Baseline, Post Treatment, 3 month follow up
Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months
Measured: Baseline, Post Treatment, 3 month folllow up
Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months
Measured: Baseline, Post Treatment, 3 month folllow up
Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months
Measured: Baseline, Post Treatment, 3 month folllow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startSep 2008
- Primary completionJul 2011
- Study completionJul 2012
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 CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Tavis S. Campbell, University of Calgary
- Investigators
- Tavis S Campbell, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335776
- Sponsor's protocol ID
- RT735639
- Acronym
- I-CAN SLEEP
- Status last verified
- Jun 2013
- First submitted
- 12 Apr 2011
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811Garland SN, Carlson LE, Stephens AJ, Antle MC, Samuels C, Campbell TS. Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: a randomized, partially blinded, noninferiority trial. J Clin Oncol. 2014 Feb 10;32(5):449-57. doi: 10.1200/JCO.2012.47.7265. Epub 2014 Jan 6.
PubMed 24395850
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Objective Comparison of Cognitive Behavioral Therapy and Mindfulness-based Stress Reduction for the Treatment of Insomnia in Cancer Survivors Using Wrist Actigraphy: A Randomized Noninferiority Trial
- ClinicalTrials.gov ID
- NCT01335776
- Acronym / sponsor ID
- I-CAN SLEEP / RT735639
- Keywords
- Mindfulness-Based Stress Reduction, Cognitive Behavior Therapy, Actigraphy, Noninferiority, MBSR, CBT-I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Sep 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Apr 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.
Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy | Experimental | Behavioral: Cognitive Behavior TherapyCognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation. |
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-Based Stress ReductionThe program consists of three primary components: theoretical material related to relaxation, meditation, and the mind-body connection; experiential practice of meditation and yoga and home based practice; group process focused on problem solving and support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Non metastatic cancer
- 1 month post chemotherapy/radiation treatment (hormone treatment okay)
- Diagnosis of Primary or Secondary Insomnia
Key exclusion criteria (6 listed)
- Presence of another sleep disorder
- Presence of another Axis I diagnosis (not in remission)
- Inability to attend at least 5 out of the 8 treatment sessions
- Randomization Refusal
- Previous participation in CBT-I or MBSR
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 |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSRThis intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat. | Behavioural | Mindfulness-Based Stress Reduction |
| Cognitive Behavior TherapyAlso: CBT-IThis treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions | Behavioural | Cognitive Behavior Therapy |
Primary outcome
Change in Insomnia Severity from baseline to 3 months
Time frame: Baseline, Post-Treatment, 3 month follow up
6 secondary outcomes
Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
Time frame: Baseline, Post Treatment, 3 month follow up
Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months
Time frame: Baseline (one week), During treatment (7 weeks), Post Treatment (1 week), 3 month Follow up (1 week)
Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months
Time frame: Baseline, Post Treatment, 3 month follow up
Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months
Time frame: Baseline, Post Treatment, 3 month folllow up
Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months
Time frame: Baseline, Post Treatment, 3 month folllow up
Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months
Time frame: Baseline, Post Treatment, 3 month folllow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
- Derived from this study: PubMed 24395850Garland SN, Carlson LE, Stephens AJ, Antle MC, Samuels C, Campbell TS. Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: a randomized, partially blinded, noninferiority trial. J Clin Oncol. 2014 Feb 10;32(5):449-57. doi: 10.1200/JCO.2012.47.7265. Epub 2014 Jan 6.
- Related InfoLink 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.
Tavis S Campbell, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction and Cognitive Behavior Therapy in people with Cancer and Insomnia, run by University of Calgary 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Insomnia Severity from baseline to 3 months (time frame: Baseline, Post-Treatment, 3 month follow up). 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 NCT01335776, 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 19 Jun 2013.