CancerNCT02774369
Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)
A study testing Physical exercise and Cognitive-behavioral therapy in people with Cancer and Insomnia, run by CHU de Quebec-Universite Laval.
Trial summary
It has been suggested that the practice of physical exercise can improve sleep, but few studies have investigated this issue in the context of cancer, despite the proven benefits of exercise in this population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Physical exercise and Cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of non-metastatic cancer
- adjuvant treatments completed within the past 6 months
- insomnia symptoms as defined by a score ≥ 8 on the Insomnia Severity Index
- practicing less than 90 minutes of physical exercise per week
- able to readily read and understand French
- available during a consecutive 6-week period to complete the intervention
- written permission from physician to engage in a physical exercise program
Who cannot join
- severe cognitive impairments (e.g., diagnosis of Parkinson disease)
- severe psychiatric disorder (e.g., severe major depression)
- diagnosis of a sleep disorder other than insomnia (e.g., obstructive sleep apnea)
- any contraindication for the practice of physical exercise
About this study
It has been suggested that the practice of physical exercise can improve sleep, but few studies have investigated this issue in the context of cancer, despite the proven benefits of exercise in this population. This randomized-controlled trial (RCT) aimed to compare the efficacy of an aerobic intervention program to that of a self-administered cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and women with insomnia symptoms and treated within 6 months for a non-metastatic cancer participated in the study.
- Being tested
- Physical exercise, Cognitive-behavioral therapy
- Keywords
- cancer, insomnia, sleep, physical exercise, aerobic, cognitive-behavioral therapy, self-help, RCT
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
Individualized aerobic intervention program
Cognitive-behavioral therapyBehavioural
Also called CBT
Psychological intervention combining behavioral, cognitive, and educational strategies
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise | Experimental | A 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition. Receives: Behavioral: Physical exercise |
| Cognitive-behavioral therapy | Active comparator | A 6-week self-administered cognitive-behavioral therapy for insomnia composed of a 60-min video (DVD format) and 6 booklets. Receives: Behavioral: Cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index total score
A 7-item questionnaire evaluating the perceived severity of sleep difficulties. The total score is the main outcome (ranging from 0 to 28).
Measured: Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4)
Secondary outcomes (6)
Change in sleep efficiency (SE) index (%)
total sleep time/total time spent in bed X 100 - from sleep diary
Measured: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in sleep onset latency (SOL) - from sleep diary
time to sleep after lights out - from sleep diary
Measured: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in wake after sleep onset (WASO) - from sleep diary
summation of nocturnal awakenings - from sleep diary
Measured: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in total sleep time (TST) - from sleep diary
time in bed minus total wake time - from sleep diary
Measured: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in Fatigue Symptom Inventory total score
A 15-item questionnaire measuring perceived fatigue. The total score ranges from 15 to 75.
Measured: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in Hospital Anxiety and Depression Scale
A 14-item questionnaire comprising 7 items assessing depression (HADS-D) and 7 items assessing anxiety (HADS-A). Scores obtained for each subscale range from 0 to 21.
Measured: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionJun 2015
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.
- 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josée Savard, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774369
- Sponsor's protocol ID
- 2012-933, A12-04-933
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 41170811Mercier J, Ivers H, Savard J. A non-inferiority randomized controlled trial comparing a home-based aerobic exercise program to a self-administered cognitive-behavioral therapy for insomnia in cancer patients. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy149.
PubMed 30053196
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)
- ClinicalTrials.gov ID
- NCT02774369
- Acronym / sponsor ID
- 2012-933, A12-04-933
- Keywords
- cancer, insomnia, sleep, physical exercise, aerobic, cognitive-behavioral therapy, self-help, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 May 2016 (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.
It has been suggested that the practice of physical exercise can improve sleep, but few studies have investigated this issue in the context of cancer, despite the proven benefits of exercise in this population. This randomized-controlled trial (RCT) aimed to compare the efficacy of an aerobic intervention program to that of a self-administered cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and women with insomnia symptoms and treated within 6 months for a non-metastatic cancer participated in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical exercise | Experimental | Behavioral: Physical exerciseA 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition. |
| Cognitive-behavioral therapy | Active comparator | Behavioral: Cognitive-behavioral therapyA 6-week self-administered cognitive-behavioral therapy for insomnia composed of a 60-min video (DVD format) and 6 booklets. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a diagnosis of non-metastatic cancer
- adjuvant treatments completed within the past 6 months
- insomnia symptoms as defined by a score ≥ 8 on the Insomnia Severity Index
- practicing less than 90 minutes of physical exercise per week
- able to readily read and understand French
Key exclusion criteria (4 listed)
- severe cognitive impairments (e.g., diagnosis of Parkinson disease)
- severe psychiatric disorder (e.g., severe major depression)
- diagnosis of a sleep disorder other than insomnia (e.g., obstructive sleep apnea)
- any contraindication for the practice of physical exercise
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 |
|---|---|---|
| Physical exerciseIndividualized aerobic intervention program | Behavioural | Physical exercise |
| Cognitive-behavioral therapyAlso: CBTPsychological intervention combining behavioral, cognitive, and educational strategies | Behavioural | Cognitive-behavioral therapy |
Primary outcome
Change in Insomnia Severity Index total score
Time frame: Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4)
A 7-item questionnaire evaluating the perceived severity of sleep difficulties. The total score is the main outcome (ranging from 0 to 28).
6 secondary outcomes
Change in sleep efficiency (SE) index (%)
Time frame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in sleep onset latency (SOL) - from sleep diary
Time frame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in wake after sleep onset (WASO) - from sleep diary
Time frame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in total sleep time (TST) - from sleep diary
Time frame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in Fatigue Symptom Inventory total score
Time frame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Change in Hospital Anxiety and Depression Scale
Time frame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
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 17 May 2016.
- 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 30053196Mercier J, Ivers H, Savard J. A non-inferiority randomized controlled trial comparing a home-based aerobic exercise program to a self-administered cognitive-behavioral therapy for insomnia in cancer patients. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy149.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and Cognitive-behavioral therapy in people with Cancer and Insomnia, run by CHU de Quebec-Universite Laval.
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 7 inclusion and 4 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Index total score (time frame: Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4)). 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 NCT02774369, 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 17 May 2016.