InsomniaNCT04817163
Implementation of CBT-I in Cancer Clinics
A study testing Web-based cognitive-behavioral therapy for insomnia (CBT-I) and Professionally-administered booster face-to-face CBT-I sessions in people with Insomnia, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Web-based cognitive-behavioral therapy for insomnia (CBT-I) and Professionally-administered booster face-to-face CBT-I sessions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 13 Dec 2019to 30 May 2025
- 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
- have received a diagnosis of non-metastatic cancer (any type)
- to be aged 18 years and older
- to be readily able to read and understand French or English
- having the minimum cognitive abilities to read, understand and memorize information
- having access to Internet
Who cannot join
- having a psychological comorbidity needing clinical attention (e.g., major depressive disorder)
- having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia)
- having insomnia due to a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche de L'Hôtel-Dieu de Québec
Québec, G1R 2J6
Emilie Godin, B.A., 1-418-525-4444 ext. 67428, emilie.godin@crchudequebec.ulaval.ca
Josée Savard, Ph.D.
About this study
Official title: Implementation of a Stepped Care Cognitive-Behavioral Therapy for Insomnia in Routine Cancer Care
Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered routinely in cancer clinics. Self-administered CBT-I (e.g., video-based intervention) has been developed to increase patients' access to this treatment. However, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. In stepped care, patients receive only the level of intervention they need. Generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). The investigators have recently assessed the efficacy of a stepped care model to administer CBT-I in cancer patients, which includes a web-based CBT-I (called Insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. Results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (Savard, Ivers, et al., in revision), while being more cost-effective. A stepped care CBT-I could therefore be offered in routine cancer care clinics.
This project will assess the feasibility and effectiveness of implementing a stepped care CBT-I in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. The program is called Insomnia in Patients with Cancer - Personalized Treatment (IMPACT). The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.
- Conditions
- Insomnia
- Being tested
- Web-based cognitive-behavioral therapy for insomnia (CBT-I), Professionally-administered booster face-to-face CBT-I sessions
- Keywords
- Insomnia, Cancer, Cognitive-behavioral therapy, Stepped care model, Self-administered treatment, Web-based intervention, Implementation, Cost-effectiveness
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based cognitive-behavioral therapy for insomnia (CBT-I)Behavioural
Also called Self-administered
Each week, the patients first have to read written information on the website (www.insomnet.ca), and then watch a video capsule (duration between 5 and 20 min each). Patients complete their daily sleep diary electronically on the website and the content is interactive. It includes the sending of automated emails to remind participants to complete the treatment tasks and encourage adherence, provision of tailored feedback (e.g., texts, charts) based on the information that they provide in their sleep diary, as well as quizzes with automated correction to reinforce patients' understanding of the content.
Professionally-administered booster face-to-face CBT-I sessionsBehavioural
Patients who obtain an ISI score of 8 and more after completing the web-based CBT-I are "stepped up" and offered to receive up to three 50-min booster sessions of CBT-I offered individually by a psychologist (if needed). Remitted patients (good sleepers; ISI score lower than 8) will receive no further treatment.
| Study group | Role | What they receive |
|---|---|---|
| Stepped care CBT-I | Experimental | Not described Receives: Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I); Behavioral: Professionally-administered booster face-to-face CBT-I sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation (organizational) measures
Referral, enrolment and completion rates to the stepped care CBT-I in each clinical setting.
Measured: Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months
1) Change in Insomnia Severity Index Scores
Change in Insomnia Severity Index Scores from pre- to post-intervention. The ISI is a 7-item questionnaire designed to evaluate insomnia severity. A score greater than or equal to 8 indicates the presence of insomnia symptoms.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
2) Change in sleep efficiency (SE)
Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep efficiency (SE) index (%) = Total sleep time/total time spent in bed X 100.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
3) Change in sleep onset latency (SOL)
Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep onset latency (SOL) = Time to sleep after lights out.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
4) Change in wake after sleep onset (WASO)
Change in daily sleep diary parameters from pre- to post-intervention: Change in wake after sleep onset (WASO) = Summation of nocturnal awakenings.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
5) Change in total wake time (TWT)
Change in daily sleep diary parameters from pre- to post-intervention: Change in total wake time (TWT) = Summation of SOL, WASO, and early morning awakening.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
6) Change in total sleep time (TST)
Change in daily sleep diary parameters from pre- to post-intervention: Change in total sleep time (TST) = Time in bed minus total wake time.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
7) Hospital Anxiety and Depression Scale (HADS)
Change scores from pre to post-intervention: Hospital Anxiety and Depression Scale (HADS): A 14-item questionnaire comprising 7 items assessing depression and 7 items assessing anxiety. Scores obtained for each subscale range from 0 to 21.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
8) Fatigue Symptom Inventory (FSI)
Change scores from pre to post-intervention: Fatigue Symptom Inventory (FSI): A 14-item questionnaire measuring perceived fatigue. Each item is rated on an 11-point Likert scale, ranging from 0 to 10. A higher score indicates a higher level of fatigue or interference or a longer duration of fatigue.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
9) The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Change scores from pre to post-intervention: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): A 30-item questionnaire. Scores are transformed to give a score ranging from 0 to 100.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
10) Satisfaction with Life Scale (SWLS)
Change scores from pre to post-intervention: Satisfaction with Life Scale (SWLS): A 5-item questionnaire (Likert scale from 1 to 7) designed to measure global cognitive judgments of satisfaction with one's life.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
1) Psychologists' adherence to the protocol
Psychologists' self-assessed adherence to the CBT-I protocol (%)
Measured: Throughout the active phase, up to 20 months
2) Psychologists' perceived self-efficiency
Psychologists' perceived self-efficiency in using CBT-I protocol (%)
Measured: Throughout the active phase, up to 20 months
Secondary outcomes (8)
1) Demographic characteristics
Clinicians and patients' demographics (e.g., age, sex)
Measured: Pre-treatment and post-treatment (6-8 weeks later) for patient; Through study completion (an average of 24 months) for clinicians
2) Evidence-Based Practice Attitudes Scale (EBPAS)
Administrators' and clinicians' attitude towards empirically-based treatments (Evidence-Based Practice Attitudes Scale (EBPAS; 15 items)): Scores obtained range from 0 to 60.
Measured: Through study completion, an average of 24 months
3) Workplace Stress Scale (WSS)
Stress at work (Workplace Stress Scale (WSS; 8 items)): Scores obtained range from 8 to 40.
Measured: Through study completion, an average of 24 months
4) Organizational Readiness for Implementing Change (ORIC)
Attitude towards change (Organizational Readiness for Implementing Change (ORIC; 12 items)): Participants rated the hospital's readiness for implementation on 12 items using a 5-point ordinal scale that ranged from "disagree" (1) to "agree" (5).
Measured: Through study completion, an average of 24 months
5) Clinicians expertise
Clinicians' CBT expertise (number of years of experience with CBT)
Measured: Through study completion, an average of 24 months
6) Internet Evaluation and Utility Questionnaire (IEUQ)
Patients' familiarity with the Internet (Internet Evaluation and Utility Questionnaire (IEUQ; 15 items)): Patients respond to the questions on a 5-point likert scale from "not at all" (0) to "very" (4), with 2 open-ended items asking patients to identify "most helpful" and "least helpful" parts of the web program.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
7) Brief Health Literacy Screening Tool (BRIEF)
Health literacy (Brief Health Literacy Screening Tool (BRIEF; 4 items)): Each item ranges from 1 to 5 and total scores range from 4 to 20.
Measured: Pre-treatment and post-treatment (6-8 weeks later)
Possible moderating treatment effect
Possible moderating treatment effect by some of the participants' characteristics (e.g., age, sex, cancer site).
Measured: Pre-treatment (at recruitment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start13 Dec 2019
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Josée Savard, CHU de Quebec-Universite Laval
- Investigators
- Josée Savard, Ph.D., Principal investigator, Centre de recherche du CHU de Québec-Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817163
- Sponsor's protocol ID
- IC118713
- Status last verified
- Sep 2024
- First submitted
- 18 Mar 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Stepped Care Cognitive-Behavioral Therapy for Insomnia in Routine Cancer Care
- ClinicalTrials.gov ID
- NCT04817163
- Acronym / sponsor ID
- IC118713
- Conditions
- Insomnia
- Keywords
- Insomnia, Cancer, Cognitive-behavioral therapy, Stepped care model, Self-administered treatment, Web-based intervention, Implementation, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 26 Mar 2021 (actual)
- 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.
Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered routinely in cancer clinics. Self-administered CBT-I (e.g., video-based intervention) has been developed to increase patients' access to this treatment. However, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. In stepped care, patients receive only the level of intervention they need. Generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). The investigators have recently assessed the efficacy of a stepped care model to administer CBT-I in cancer patients, which includes a web-based CBT-I (called Insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. Results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (Savard, Ivers, et al., in revision), while being more cost-effective. A stepped care CBT-I could therefore be offered in routine cancer care clinics.
This project will assess the feasibility and effectiveness of implementing a stepped care CBT-I in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. The program is called Insomnia in Patients with Cancer - Personalized Treatment (IMPACT). The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.
| Arm | Type | Receives |
|---|---|---|
| Stepped care CBT-I | Experimental | Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I), Behavioral: Professionally-administered booster face-to-face CBT-I sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have received a diagnosis of non-metastatic cancer (any type)
- to be aged 18 years and older
- to be readily able to read and understand French or English
- having the minimum cognitive abilities to read, understand and memorize information
- having access to Internet
Key exclusion criteria (3 listed)
- having a psychological comorbidity needing clinical attention (e.g., major depressive disorder)
- having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia)
- having insomnia due to a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)
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 |
|---|---|---|
| Web-based cognitive-behavioral therapy for insomnia (CBT-I)Also: Self-administeredEach week, the patients first have to read written information on the website (www.insomnet.ca), and then watch a video capsule (duration between 5 and 20 min each). Patients complete their daily sleep diary electronically on the website and the content is interactive. It includes the sending of automated emails to remind participants to complete the treatment tasks and encourage adherence, provision of tailored feedback (e.g., texts, charts) based on the information that they provide in their sleep diary, as well as quizzes with automated correction to reinforce patients' understanding of the content. | Behavioural | Stepped care CBT-I |
| Professionally-administered booster face-to-face CBT-I sessionsPatients who obtain an ISI score of 8 and more after completing the web-based CBT-I are "stepped up" and offered to receive up to three 50-min booster sessions of CBT-I offered individually by a psychologist (if needed). Remitted patients (good sleepers; ISI score lower than 8) will receive no further treatment. | Behavioural | Stepped care CBT-I |
Primary outcome
Implementation (organizational) measures
Time frame: Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months
Referral, enrolment and completion rates to the stepped care CBT-I in each clinical setting.
1) Change in Insomnia Severity Index Scores
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change in Insomnia Severity Index Scores from pre- to post-intervention. The ISI is a 7-item questionnaire designed to evaluate insomnia severity. A score greater than or equal to 8 indicates the presence of insomnia symptoms.
2) Change in sleep efficiency (SE)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep efficiency (SE) index (%) = Total sleep time/total time spent in bed X 100.
3) Change in sleep onset latency (SOL)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep onset latency (SOL) = Time to sleep after lights out.
4) Change in wake after sleep onset (WASO)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change in daily sleep diary parameters from pre- to post-intervention: Change in wake after sleep onset (WASO) = Summation of nocturnal awakenings.
5) Change in total wake time (TWT)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change in daily sleep diary parameters from pre- to post-intervention: Change in total wake time (TWT) = Summation of SOL, WASO, and early morning awakening.
6) Change in total sleep time (TST)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change in daily sleep diary parameters from pre- to post-intervention: Change in total sleep time (TST) = Time in bed minus total wake time.
7) Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change scores from pre to post-intervention: Hospital Anxiety and Depression Scale (HADS): A 14-item questionnaire comprising 7 items assessing depression and 7 items assessing anxiety. Scores obtained for each subscale range from 0 to 21.
8) Fatigue Symptom Inventory (FSI)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change scores from pre to post-intervention: Fatigue Symptom Inventory (FSI): A 14-item questionnaire measuring perceived fatigue. Each item is rated on an 11-point Likert scale, ranging from 0 to 10. A higher score indicates a higher level of fatigue or interference or a longer duration of fatigue.
9) The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change scores from pre to post-intervention: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): A 30-item questionnaire. Scores are transformed to give a score ranging from 0 to 100.
10) Satisfaction with Life Scale (SWLS)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Change scores from pre to post-intervention: Satisfaction with Life Scale (SWLS): A 5-item questionnaire (Likert scale from 1 to 7) designed to measure global cognitive judgments of satisfaction with one's life.
1) Psychologists' adherence to the protocol
Time frame: Throughout the active phase, up to 20 months
Psychologists' self-assessed adherence to the CBT-I protocol (%)
2) Psychologists' perceived self-efficiency
Time frame: Throughout the active phase, up to 20 months
Psychologists' perceived self-efficiency in using CBT-I protocol (%)
8 secondary outcomes
1) Demographic characteristics
Time frame: Pre-treatment and post-treatment (6-8 weeks later) for patient; Through study completion (an average of 24 months) for clinicians
2) Evidence-Based Practice Attitudes Scale (EBPAS)
Time frame: Through study completion, an average of 24 months
3) Workplace Stress Scale (WSS)
Time frame: Through study completion, an average of 24 months
4) Organizational Readiness for Implementing Change (ORIC)
Time frame: Through study completion, an average of 24 months
5) Clinicians expertise
Time frame: Through study completion, an average of 24 months
6) Internet Evaluation and Utility Questionnaire (IEUQ)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
7) Brief Health Literacy Screening Tool (BRIEF)
Time frame: Pre-treatment and post-treatment (6-8 weeks later)
Possible moderating treatment effect
Time frame: Pre-treatment (at recruitment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Josée Savard, Ph.D. principal investigator
Centre de recherche du CHU de Québec-Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based cognitive-behavioral therapy for insomnia (CBT-I) and Professionally-administered booster face-to-face CBT-I sessions in people with Insomnia, run by CHU de Quebec-Universite Laval 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 5 inclusion and 3 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 19 Sep 2024. 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?
Contact Josée Savard, Ph.D. (418-525-4444 ext. 20622, josee.savard@psy.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation (organizational) measures (time frame: Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2024.