CancerNCT05409638
Why am I Still Tired ? A Group for Cancer-related Fatigue
A study testing Cognitive Behavioral Therapy to manage cancer-related fatigue in people with Cancer and Fatigue, run by University of Ottawa at 1 site in Canada.
Trial summary
Cancer related fatigue (CRF) has been defined as a "distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning". Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Cognitive Behavioral Therapy to manage cancer-related fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2022to 17 Feb 2023
- 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
- Aged 18 and over
- Has received a cancer diagnosis
- Has completed cancer treatment,
- Self-reports experiencing fatigue,
- Fluent in English.
Who cannot join
- Currently in treatment
- Has a diagnosis of brain cancer and is experiencing cognitive difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Why am I Still Tired? Adaption, Implementation, and Evaluation of an Intervention for Cancer-Related Fatigue.
Cancer related fatigue (CRF) has been defined as a "distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning". CRF has been found to affect between 59-99% of patients undergoing active treatment. Approximately a third of cancer survivors will continue to experience moderate to severe fatigue upwards of 10 years post-diagnosis. Given the prominence of CRF, guidelines for the assessment and management of CRF have been developed, including guidelines by the Canadian Association for Psychosocial Oncology (CAPO). Despite the availability of guidelines for CRF and a plethora of interventions that have demonstrated effectiveness in aiding patients manage CRF, implementation has been lacking. The objective of this study is to adapt, implement, and evaluate an already existing intervention for CRF in the community using the Knowledge-to-Action framework. This study is an implementation study and evaluation of an evidence-based cognitive-behavioral therapy intervention for CRF in a community setting. An evident knowledge to practice gap exists for CRF management in Ottawa, Canada. Through partnership with a community organization, the Ottawa Regional Cancer Foundation, and an emphasis on long-term sustainability, this project aims to provide more accessible treatment for cancer survivors who are experiencing CRF in the Ottawa region.
Read the detailed description
This study is a single center, hybrid II effectiveness-implementation pilot study. For the effectiveness trial, the investigators will use a randomized controlled trial with a waitlist control group. For the implementation portion of the study, the investigators will conduct a process evaluation using the RE-AIM framework. Three groups of 10-15 cancer survivors will take part in CrF intervention. Three groups were selected with consultation of the Ottawa Regional Cancer Foundation as it currently offers groups three times a year in the fall, winter, and spring/summer. Another three groups of approximately 10 cancer survivors will be allocated to a 3-month wait-list control group after which they will be offered the CrF intervention. Participants will be recruited through several methods: online advertisements, informational letters and posters sent to community and healthcare organizations and key healthcare providers (i.e., family physicians and health psychologists).
Effectiveness Component:
Participation will consist of attending 90-minute virtual groups for 4 consecutive weeks on cancer-related fatigue. During the 4 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework. They will also be asked to complete a questionnaire package before the start of the intervention, one week after the intervention is completed (5 weeks), and at 3-months post intervention. The questionnaires package will include the following questionnaires. The primary outcome will be the Multidimensional Fatigue Inventory (MFI-20). Secondary outcomes will be the Functional Assessment of Chronic Illness Therapy (FACIT-F), PROMIS Self-Efficacy for Managing Chronic Conditions-Short Form, Godin Leisure-Time Exercise Questionnaire, The Insomnia Severity Index, and the Hospital Anxiety and Depression Scale (HADS). After the completion of the intervention, they will also be asked to fill out a satisfaction survey once at 5 weeks where they can provide feedback on their experience of the intervention, a component of the process evaluation (see the next section for more detail). All surveys should take approximately 30 minutes. The waitlist control group, participation will consist of completing a 30- minute questionnaire package at the start of the study, after 5 weeks and at a 3-month follow-up. The same questionnaire package will be administered that the intervention group receives with the exception of the satisfaction survey. After three months, participants will be offered the chance to receive the intervention for cancer-related fatigue. They will only be asked to complete the satisfaction survey where they can provide feedback on your experience of the intervention and have the option to participate in the focus group should they wish too. However, they will not be asked to re-complete the questionnaire packages they completed during their wait time. Block randomization with a 1:1 ratio will be completed through an online software. The following sociodemographic data will be collected: age, gender, marital status, education, work class, ethnicity, cancer diagnosis, medication, other chronic illness, history of insomnia and/or depression, smoking, location, income, and comfort with technology.
Implementation component:
This process evaluation will follow a RE-AIM framework. For reach, the investigators will document the number of individuals interested in the intervention and referral sources through the patient demographic form. During past focus groups, the investigators discovered a break-down in communication between community partner, patients, and healthcare organizations. To increase reach and improve this gap, the investigators have several strategies including online advertisements, knowledge dissemination through informational letters to key providers (i.e., family doctors, health psychologists), and offering presenting to community organizations and healthcare organizations. Additionally, feasibility will be assessed retrospectively to examine whether the program was a success or failure, specifically in regard to recruitment, retention, and participation rates. Recruitment numbers and referrals, retention (i.e., percentage of individuals who complete the program), and participation rates (i.e., attendance) will all be tracked throughout the project. If possible, participants will be contacted and asked for the reason of discontinuing the program. For effectiveness, the randomized control trial described above will be conducted. For adoption, the investigators will interview key stakeholders at the Ottawa Regional Cancer Foundation about the barriers and facilitators in maintaining this intervention long-term. The investigators will also be accessing acceptability of the intervention through the evaluation tool created by the Ottawa Regional Cancer Foundation. Evaluation Measure Designed by the Ottawa Regional Cancer Foundation: Currently, programs at the Ottawa Regional Cancer Foundation are routinely evaluated with an evaluation tool. The questionnaire is composed of open-ended questions (e.g., how could the program be improved?) and Likert scales questions on satisfaction (e.g., I would recommend this coaching program to others) and perceived knowledge/skills gained (e.g., this program helped me develop strategies to better cope with life). Further, focus groups (N=3) with 6-10 cancer survivors each who have completed the intervention will be held to gain greater insight into their perspectives of the intervention and which aspects were the most and least beneficial after each group. To assess the quality of training the staff member received, an individual interview will be conducted to ascertain the staff members' confidence and level of preparedness in providing the intervention. In addition, the staff member will be asked about their perspectives of the program and whether they recommend any changes. As the evaluator will be providing the training, the staff interview will be conducted by another graduate student to reduce desirability bias and to ensure the group facilitator can express their honest opinions. For implementation, the investigators will conduct approximate intervention cost-tracking by determining the number of hours the community partner puts into the intervention (i.e., training and facilitating the intervention). Additionally, the intervention will be video recorded, and a fidelity checklist will be completed to ensure high consistency of the intervention. Lastly, for maintenance will be document whether the program is planned to be offered regularly after the investigators have completed our research study
- Being tested
- Cognitive Behavioral Therapy to manage cancer-related fatigue
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy to manage cancer-related fatigueBehavioural
Participation will consist of attending 90-minute virtual groups for 4 consecutive weeks on cancer-related fatigue. During the 4 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework.
| Study group | Role | What they receive |
|---|---|---|
| CBT intervention for cancer-related fatigue | Experimental | Participants will receive 4 weekly sessions consisting of psycho-education around fatigue, pacing, journaling fatigue, relaxation training, CBT, and evidence-based tips to increase physical activity. Receives: Behavioral: Cognitive Behavioral Therapy to manage cancer-related fatigue |
| Wait-list control group | No intervention | Participants assigned to this arm wait about 3-months to receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in baseline fatigue at one month
Multidimensional Fatigue Inventory (MFI-20), range from 20 to 100 with higher scores indicating greater fatigue
Measured: Changes in fatigue at 1 month after the completion of the intervention
Changes in baseline fatigue at three months
Multidimensional Fatigue Inventory (MFI-20), range from 20 to 100 with higher scores
Measured: Changes in fatigue at 3 month after the completion of the intervention
Secondary outcomes (11)
Changes in baseline fatigue at 1 month
Functional Assessment of Chronic Illness Therapy (FACIT-F) with a score range 0-52 with higher scores indicating better quality of life and less fatigue
Measured: Changes in fatigue at 1 month after the completion of the intervention
Changes in baseline fatigue at 3 months month
Functional Assessment of Chronic Illness Therapy (FACIT-F) with a score range 0-52 with higher scores indicating better quality of life and less fatigue
Measured: Changes in fatigue at 3 month after the completion of the intervention
Changes in baseline physical activity at 1 month
Godin Leisure-Time Exercise with a score range from 0 to 119 with higher scores indicating greater physical activity
Measured: Changes in physical activity at 1 month after the completion of the intervention
Changes in baseline physical activity at 3 months
Godin Leisure-Time Exercise with a score range from 0 to 119 with higher scores indicating greater physical activity
Measured: Changes in physical activity at 3 month after the completion of the intervention
Changes in baseline depression and anxiety at 1 month
Hospital Anxiety and Depression Scale Depression and anxiety (HADS) measure with a range from 0 to 42 with greater scores indicating more distress
Measured: Changes in depression and anxiety 1 month after the completion of the intervention
Changes in baseline depression and anxiety at 3 months
Hospital Anxiety and Depression Scale Depression and anxiety (HADS) measure with a range from 0 to 42 with greater scores indicating more distress
Measured: Changes in depression and anxiety 3 months after the completion of the intervention
Changes in baseline insomnia at 1 month
Insomnia Severity Index with a score range from 0-28 with higher scores indicating greater insomnia
Measured: Changes in insomnia at 1 month after the completion of the intervention
Changes in baseline insomnia at 3 month
Insomnia Severity Index with a score range from 0-28 with higher scores indicating greater insomnia
Measured: Changes in insomnia at 3 months after the completion of the intervention
Changes in baseline self-efficacy at 1 month
PROMIS Self-Efficacy for Managing Chronic Conditions with a score ranging from 0-10 with higher scores indicating greater self-efficacy
Measured: Changes in self-efficacy at 1 month after the completion of the intervention
Changes in baseline self-efficacy at 3 months
PROMIS Self-Efficacy for Managing Chronic Conditions with a score ranging from 0-10 with higher scores indicating greater self-efficacy
Measured: Changes in self-efficacy at 3 months after the completion of the intervention
Satisfaction with the intervention
Evaluation Measure Designed by the Ottawa Regional Cancer Foundation with score range from 19 to 95 with higher scores indicating greater satisfaction with the intervention
Measured: One time, 1 month after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jan 2022
- Primary completion1 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Lebel, University of Ottawa
- Investigators
- Sophie Lebel, PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409638
- Sponsor's protocol ID
- 603412-190799-2001
- Status last verified
- May 2023
- First submitted
- 6 May 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- 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 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why am I Still Tired? Adaption, Implementation, and Evaluation of an Intervention for Cancer-Related Fatigue.
- ClinicalTrials.gov ID
- NCT05409638
- Acronym / sponsor ID
- 603412-190799-2001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 8 Jun 2022 (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.
Cancer related fatigue (CRF) has been defined as a "distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning". CRF has been found to affect between 59-99% of patients undergoing active treatment. Approximately a third of cancer survivors will continue to experience moderate to severe fatigue upwards of 10 years post-diagnosis. Given the prominence of CRF, guidelines for the assessment and management of CRF have been developed, including guidelines by the Canadian Association for Psychosocial Oncology (CAPO). Despite the availability of guidelines for CRF and a plethora of interventions that have demonstrated effectiveness in aiding patients manage CRF, implementation has been lacking. The objective of this study is to adapt, implement, and evaluate an already existing intervention for CRF in the community using the Knowledge-to-Action framework. This study is an implementation study and evaluation of an evidence-based cognitive-behavioral therapy intervention for CRF in a community setting. An evident knowledge to practice gap exists for CRF management in Ottawa, Canada. Through partnership with a community organization, the Ottawa Regional Cancer Foundation, and an emphasis on long-term sustainability, this project aims to provide more accessible treatment for cancer survivors who are experiencing CRF in the Ottawa region.
Detailed description
This study is a single center, hybrid II effectiveness-implementation pilot study. For the effectiveness trial, the investigators will use a randomized controlled trial with a waitlist control group. For the implementation portion of the study, the investigators will conduct a process evaluation using the RE-AIM framework. Three groups of 10-15 cancer survivors will take part in CrF intervention. Three groups were selected with consultation of the Ottawa Regional Cancer Foundation as it currently offers groups three times a year in the fall, winter, and spring/summer. Another three groups of approximately 10 cancer survivors will be allocated to a 3-month wait-list control group after which they will be offered the CrF intervention. Participants will be recruited through several methods: online advertisements, informational letters and posters sent to community and healthcare organizations and key healthcare providers (i.e., family physicians and health psychologists).
Effectiveness Component:
Participation will consist of attending 90-minute virtual groups for 4 consecutive weeks on cancer-related fatigue. During the 4 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework. They will also be asked to complete a questionnaire package before the start of the intervention, one week after the intervention is completed (5 weeks), and at 3-months post intervention. The questionnaires package will include the following questionnaires. The primary outcome will be the Multidimensional Fatigue Inventory (MFI-20). Secondary outcomes will be the Functional Assessment of Chronic Illness Therapy (FACIT-F), PROMIS Self-Efficacy for Managing Chronic Conditions-Short Form, Godin Leisure-Time Exercise Questionnaire, The Insomnia Severity Index, and the Hospital Anxiety and Depression Scale (HADS). After the completion of the intervention, they will also be asked to fill out a satisfaction survey once at 5 weeks where they can provide feedback on their experience of the intervention, a component of the process evaluation (see the next section for more detail). All surveys should take approximately 30 minutes. The waitlist control group, participation will consist of completing a 30- minute questionnaire package at the start of the study, after 5 weeks and at a 3-month follow-up. The same questionnaire package will be administered that the intervention group receives with the exception of the satisfaction survey. After three months, participants will be offered the chance to receive the intervention for cancer-related fatigue. They will only be asked to complete the satisfaction survey where they can provide feedback on your experience of the intervention and have the option to participate in the focus group should they wish too. However, they will not be asked to re-complete the questionnaire packages they completed during their wait time. Block randomization with a 1:1 ratio will be completed through an online software. The following sociodemographic data will be collected: age, gender, marital status, education, work class, ethnicity, cancer diagnosis, medication, other chronic illness, history of insomnia and/or depression, smoking, location, income, and comfort with technology.
Implementation component:
This process evaluation will follow a RE-AIM framework. For reach, the investigators will document the number of individuals interested in the intervention and referral sources through the patient demographic form. During past focus groups, the investigators discovered a break-down in communication between community partner, patients, and healthcare organizations. To increase reach and improve this gap, the investigators have several strategies including online advertisements, knowledge dissemination through informational letters to key providers (i.e., family doctors, health psychologists), and offering presenting to community organizations and healthcare organizations. Additionally, feasibility will be assessed retrospectively to examine whether the program was a success or failure, specifically in regard to recruitment, retention, and participation rates. Recruitment numbers and referrals, retention (i.e., percentage of individuals who complete the program), and participation rates (i.e., attendance) will all be tracked throughout the project. If possible, participants will be contacted and asked for the reason of discontinuing the program. For effectiveness, the randomized control trial described above will be conducted. For adoption, the investigators will interview key stakeholders at the Ottawa Regional Cancer Foundation about the barriers and facilitators in maintaining this intervention long-term. The investigators will also be accessing acceptability of the intervention through the evaluation tool created by the Ottawa Regional Cancer Foundation. Evaluation Measure Designed by the Ottawa Regional Cancer Foundation: Currently, programs at the Ottawa Regional Cancer Foundation are routinely evaluated with an evaluation tool. The questionnaire is composed of open-ended questions (e.g., how could the program be improved?) and Likert scales questions on satisfaction (e.g., I would recommend this coaching program to others) and perceived knowledge/skills gained (e.g., this program helped me develop strategies to better cope with life). Further, focus groups (N=3) with 6-10 cancer survivors each who have completed the intervention will be held to gain greater insight into their perspectives of the intervention and which aspects were the most and least beneficial after each group. To assess the quality of training the staff member received, an individual interview will be conducted to ascertain the staff members' confidence and level of preparedness in providing the intervention. In addition, the staff member will be asked about their perspectives of the program and whether they recommend any changes. As the evaluator will be providing the training, the staff interview will be conducted by another graduate student to reduce desirability bias and to ensure the group facilitator can express their honest opinions. For implementation, the investigators will conduct approximate intervention cost-tracking by determining the number of hours the community partner puts into the intervention (i.e., training and facilitating the intervention). Additionally, the intervention will be video recorded, and a fidelity checklist will be completed to ensure high consistency of the intervention. Lastly, for maintenance will be document whether the program is planned to be offered regularly after the investigators have completed our research study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT intervention for cancer-related fatigue | Experimental | Behavioral: Cognitive Behavioral Therapy to manage cancer-related fatigueParticipants will receive 4 weekly sessions consisting of psycho-education around fatigue, pacing, journaling fatigue, relaxation training, CBT, and evidence-based tips to increase physical activity. |
| Wait-list control group | No intervention | –Participants assigned to this arm wait about 3-months to receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 and over
- Has received a cancer diagnosis
- Has completed cancer treatment,
- Self-reports experiencing fatigue,
- Fluent in English.
Key exclusion criteria (2 listed)
- Currently in treatment
- Has a diagnosis of brain cancer and is experiencing cognitive difficulties
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 |
|---|---|---|
| Cognitive Behavioral Therapy to manage cancer-related fatigueParticipation will consist of attending 90-minute virtual groups for 4 consecutive weeks on cancer-related fatigue. During the 4 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework. | Behavioural | CBT intervention for cancer-related fatigue |
Primary outcome
Changes in baseline fatigue at one month
Time frame: Changes in fatigue at 1 month after the completion of the intervention
Multidimensional Fatigue Inventory (MFI-20), range from 20 to 100 with higher scores indicating greater fatigue
Changes in baseline fatigue at three months
Time frame: Changes in fatigue at 3 month after the completion of the intervention
Multidimensional Fatigue Inventory (MFI-20), range from 20 to 100 with higher scores
11 secondary outcomes
Changes in baseline fatigue at 1 month
Time frame: Changes in fatigue at 1 month after the completion of the intervention
Changes in baseline fatigue at 3 months month
Time frame: Changes in fatigue at 3 month after the completion of the intervention
Changes in baseline physical activity at 1 month
Time frame: Changes in physical activity at 1 month after the completion of the intervention
Changes in baseline physical activity at 3 months
Time frame: Changes in physical activity at 3 month after the completion of the intervention
Changes in baseline depression and anxiety at 1 month
Time frame: Changes in depression and anxiety 1 month after the completion of the intervention
Changes in baseline depression and anxiety at 3 months
Time frame: Changes in depression and anxiety 3 months after the completion of the intervention
Changes in baseline insomnia at 1 month
Time frame: Changes in insomnia at 1 month after the completion of the intervention
Changes in baseline insomnia at 3 month
Time frame: Changes in insomnia at 3 months after the completion of the intervention
Changes in baseline self-efficacy at 1 month
Time frame: Changes in self-efficacy at 1 month after the completion of the intervention
Changes in baseline self-efficacy at 3 months
Time frame: Changes in self-efficacy at 3 months after the completion of the intervention
Satisfaction with the intervention
Time frame: One time, 1 month after completing the intervention
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 18 May 2023.
- 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.
Sophie Lebel, PhD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy to manage cancer-related fatigue in people with Cancer and Fatigue, run by University of Ottawa 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 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: finished, as of the sponsor's last update on 18 May 2023. 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?
Changes in baseline fatigue at one month (time frame: Changes in fatigue at 1 month after the completion of the intervention). The study lists 2 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 18 May 2023.