Neoplasm of Breast (Disorder)NCT03475433
An Observational Prospective Cohort Study Using an Actigraphy Device.
An observational study of Neoplasm of Breast (Disorder) and Carcinoma of Prostate (Disorder), run by Taipei Medical University at 2 sites in Taiwan.
Trial summary
This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasm of Breast (Disorder), Carcinoma of Prostate (Disorder)
- What is being tested?
- Actigraphy device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesTaiwan
- Study dates
- 15 May 2018to 31 Aug 2018
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be selected with the help of oncologists in Taiwanese hospitals, therefore all participants will be Taiwanese residents and patients of either one of the desired hospital locations in Taipei. All participants are also either breast cancer or prostate cancer patients, with a minimum age of 20 years.
Who may be able to join
- The patient:
- Is an outpatient receiving evaluation, treatment, or follow-up care at either one of the desired hospital locations in Taipei.
- Has been diagnosed with prostate or breast cancer within the past year.
- Is currently receiving treatment for the cancer.
- Is at least 20 years old.
- Is able to understand Mandarin Chinese.
Show all 9Show fewer
- Gives informed consent to participate.
- scores at least 26 on the Mini-Mental State Examination (MMSE).
- Has a score 45 or higher on the Berg Balance Scale test.
Who cannot join
- The patient:
- Cannot understand the intent of the study.
- scores lower than 26 on the Mini-Mental State Examination (MMSE).
- Is not fit to participate, as believed by their current treating physician.
- Is physical unable to walk.
- Has a score of <45 on the Berg Balance Scale test.
- Refuses to participate.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Medical University Hospital
Taipei, Taipei City, 11031
Taipei Municipal Wanfang Hospital
Taipei, Taipei City, 11696
About this study
Official title: An Observational Prospective Cohort Study About Quality of Life in Relation to the Physical Activity of Taiwanese Breast and Prostate Cancer Patients.
This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI) and the Quality of Life Questionnaire (QLQ). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device.
This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique Identification number (ID), which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.
Read the detailed description
Physical inactivity is a common issue amongst breast cancer patients. Previous studies have shown that physical activity can be beneficiary to both the cancer outcomes and the quality of life.
However, most comparable studies had western populations or included some participants of Asian descent at best. Given the growing importance of effective and efficient follow-up care [1] and the lack of research on physical activity and sleep quality in relation to the Quality of Life (QoL) of cancer patients in Asian countries, the investigators aim to monitor the physical activity, sleep quality and subjective QoL of Taiwanese breast- and prostate cancer patients. Hence the investigators' main research question is: "Does physical and/or sleep activity affect the quality of life of (Taiwanese) breast and prostate cancer patients?". If this would be the case, the results might cover the bases for an intervention study aimed at improving physical and/or sleep quality in these cancer patients.
This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device.
Lastly, the quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30). This will provide an insight in the quality of life of the subjects, which will enable the investigators to draw a conclusion whether or not physical activity and sleep quality are related to the quality of life.
This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique ID, which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.
To retrieve results from the dataset, the data analysis will be divided in two parts: correlation between sleep quality and the Quality of Life, and between physical activity and the Quality of Life. Before commencing with the analysis itself, the data will be checked for outliers and missing data.
- Being tested
- Actigraphy device
- Keywords
- Cancer, Questionnaire, Survey, Sleep Disturbance, Sleep Quality, E-health, M-health, Actigraphy, Physical activity, Dyssomnias Medical Subject Headings [MeSH], Sleep Wake Disorders [MeSH], Parasomnias [MeSH], Nervous System Diseases [MeSH], Mental Disorders [MeSH], Neurologic Manifestations [MeSH], Signs and Symptoms [MeSH], Telemedicine [MeSH], Actigraphy [MeSH], Quality of Life [MeSH], Motor Activity [MeSH]
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Neoplasms, Parasomnias, 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.
Actigraphy deviceDevice
Both groups will receive an actigraphy device that will passively measure their movement data.
| Study group | Role | What they receive |
|---|---|---|
| Beast cancer patients | All participants that suffer from breast cancer. Receives: Device: Actigraphy device | |
| Prostate cancer patients | All participants that suffer from prostate cancer. Receives: Device: Actigraphy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change will be assessed on the quality of life of breast and prostate cancer patients.
It will be measured using the scores of the Quality of Life questionnaire.
Measured: The time frame will be 8th day after enrolment of each respondent
Change will be assessed for the influence of physical activity on the Quality of Life of breast and prostate cancer patients.
It will be measured using the physical activity data from the actigraphy device.
Measured: The time frame will be daily for 8 days after enrolment of each respondent
Secondary outcomes (1)
Study whether sleep quality and the quality of life scores of breast and prostate cancer patients are correlated
This will be measured using a combination of the PSQI questionnaire and movement data during nighttime for the sleep quality, and the quality of life questionnaire scores.
Measured: The time frame will be 8th day after enrollment of each respondent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start15 May 2018
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Neoplasm of Breast (Disorder)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, University of Seville, Taipei Medical University WanFang Hospital, Taipei Medical University Hospital, Adhera Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Syed Abdul Shabbir, Dr. MD, Principal investigator, Associate Professor & Health IT Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475433
- Sponsor's protocol ID
- None yet
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data (IPD) will be shared as open research data after the results have been published. All data that might identify individuals will be stripped to make sure the data is completely anonymous.
Publications
Robison LL, Demark-Wahnefried W. Cancer survivorship: focusing on future research opportunities. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):1994-5. doi: 10.1158/1055-9965.EPI-11-0837. No abstract available.
PubMed 21980006Monga U, Kerrigan AJ, Thornby J, Monga TN. Prospective study of fatigue in localized prostate cancer patients undergoing radiotherapy. Radiat Oncol Investig. 1999;7(3):178-85. doi: 10.1002/(SICI)1520-6823(1999)7:33.0.CO;2-0.
PubMed 10406060Shin WK, Song S, Jung SY, Lee E, Kim Z, Moon HG, Noh DY, Lee JE. The association between physical activity and health-related quality of life among breast cancer survivors. Health Qual Life Outcomes. 2017 Jun 30;15(1):132. doi: 10.1186/s12955-017-0706-9.
PubMed 28666465Inbar C, Ety B, Ayala H, Tamer P. The mental health of breast cancer survivors and their adolescent daughters. Psychooncology. 2013 Jun;22(6):1236-41. doi: 10.1002/pon.3127. Epub 2012 Jul 4.
PubMed 22764063Toivonen KI, Tamagawa R, Speca M, Stephen J, Carlson LE. Open to Exploration? Association of Personality Factors With Complementary Therapy Use After Breast Cancer Treatment. Integr Cancer Ther. 2018 Sep;17(3):785-792. doi: 10.1177/1534735417753539. Epub 2018 Jan 24.
PubMed 29361852Szymlek-Gay EA, Richards R, Egan R. Physical activity among cancer survivors: a literature review. N Z Med J. 2011 Jun 24;124(1337):77-89.
PubMed 21946880Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6.
PubMed 20052559Meneses-Echavez JF, Gonzalez-Jimenez E, Ramirez-Velez R. Supervised exercise reduces cancer-related fatigue: a systematic review. J Physiother. 2015 Jan;61(1):3-9. doi: 10.1016/j.jphys.2014.08.019. Epub 2014 Dec 13.
PubMed 25511250Fortner BV, Stepanski EJ, Wang SC, Kasprowicz S, Durrence HH. Sleep and quality of life in breast cancer patients. J Pain Symptom Manage. 2002 Nov;24(5):471-80. doi: 10.1016/s0885-3924(02)00500-6.
PubMed 12547047Costa AR, Fontes F, Pereira S, Goncalves M, Azevedo A, Lunet N. Impact of breast cancer treatments on sleep disturbances - A systematic review. Breast. 2014 Dec;23(6):697-709. doi: 10.1016/j.breast.2014.09.003. Epub 2014 Oct 11.
PubMed 25307946Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.
PubMed 16155782Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24.
PubMed 18653703
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Prospective Cohort Study About Quality of Life in Relation to the Physical Activity of Taiwanese Breast and Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT03475433
- Acronym / sponsor ID
- None yet
- Keywords
- Cancer, Questionnaire, Survey, Sleep Disturbance, Sleep Quality, E-health, M-health, Actigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, University of Seville, Taipei Medical University WanFang Hospital, Taipei Medical University Hospital, Adhera Health, Inc.
- Study start
- 15 May 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 23 Mar 2018 (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.
This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI) and the Quality of Life Questionnaire (QLQ). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device.
This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique Identification number (ID), which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.
Detailed description
Physical inactivity is a common issue amongst breast cancer patients. Previous studies have shown that physical activity can be beneficiary to both the cancer outcomes and the quality of life.
However, most comparable studies had western populations or included some participants of Asian descent at best. Given the growing importance of effective and efficient follow-up care [1] and the lack of research on physical activity and sleep quality in relation to the Quality of Life (QoL) of cancer patients in Asian countries, the investigators aim to monitor the physical activity, sleep quality and subjective QoL of Taiwanese breast- and prostate cancer patients. Hence the investigators' main research question is: "Does physical and/or sleep activity affect the quality of life of (Taiwanese) breast and prostate cancer patients?". If this would be the case, the results might cover the bases for an intervention study aimed at improving physical and/or sleep quality in these cancer patients.
This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device.
Lastly, the quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30). This will provide an insight in the quality of life of the subjects, which will enable the investigators to draw a conclusion whether or not physical activity and sleep quality are related to the quality of life.
This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique ID, which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.
To retrieve results from the dataset, the data analysis will be divided in two parts: correlation between sleep quality and the Quality of Life, and between physical activity and the Quality of Life. Before commencing with the analysis itself, the data will be checked for outliers and missing data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beast cancer patients | – | Device: Actigraphy deviceAll participants that suffer from breast cancer. |
| Prostate cancer patients | – | Device: Actigraphy deviceAll participants that suffer from prostate cancer. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be selected with the help of oncologists in Taiwanese hospitals, therefore all participants will be Taiwanese residents and patients of either one of the desired hospital locations in Taipei. All participants are also either breast cancer or prostate cancer patients, with a minimum age of 20 years.
Key inclusion criteria (9 listed)
- Is an outpatient receiving evaluation, treatment, or follow-up care at either one of the desired hospital locations in Taipei.
- Has been diagnosed with prostate or breast cancer within the past year.
- Is currently receiving treatment for the cancer.
- Is at least 20 years old.
- Is able to understand Mandarin Chinese.
Key exclusion criteria (7 listed)
- Cannot understand the intent of the study.
- scores lower than 26 on the Mini-Mental State Examination (MMSE).
- Is not fit to participate, as believed by their current treating physician.
- Is physical unable to walk.
- Has a score of <45 on the Berg Balance Scale test.
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 |
|---|---|---|
| Actigraphy deviceBoth groups will receive an actigraphy device that will passively measure their movement data. | Device | Beast cancer patients, Prostate cancer patients |
Primary outcome
Change will be assessed on the quality of life of breast and prostate cancer patients.
Time frame: The time frame will be 8th day after enrolment of each respondent
It will be measured using the scores of the Quality of Life questionnaire.
Change will be assessed for the influence of physical activity on the Quality of Life of breast and prostate cancer patients.
Time frame: The time frame will be daily for 8 days after enrolment of each respondent
It will be measured using the physical activity data from the actigraphy device.
1 secondary outcome
Study whether sleep quality and the quality of life scores of breast and prostate cancer patients are correlated
Time frame: The time frame will be 8th day after enrollment of each respondent
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 10 Apr 2019.
- Background: PubMed 21980006Robison LL, Demark-Wahnefried W. Cancer survivorship: focusing on future research opportunities. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):1994-5. doi: 10.1158/1055-9965.EPI-11-0837. No abstract available.
- Background: PubMed 10406060Monga U, Kerrigan AJ, Thornby J, Monga TN. Prospective study of fatigue in localized prostate cancer patients undergoing radiotherapy. Radiat Oncol Investig. 1999;7(3):178-85. doi: 10.1002/(SICI)1520-6823(1999)7:33.0.CO;2-0.
- Background: PubMed 28666465Shin WK, Song S, Jung SY, Lee E, Kim Z, Moon HG, Noh DY, Lee JE. The association between physical activity and health-related quality of life among breast cancer survivors. Health Qual Life Outcomes. 2017 Jun 30;15(1):132. doi: 10.1186/s12955-017-0706-9.
- Background: PubMed 22764063Inbar C, Ety B, Ayala H, Tamer P. The mental health of breast cancer survivors and their adolescent daughters. Psychooncology. 2013 Jun;22(6):1236-41. doi: 10.1002/pon.3127. Epub 2012 Jul 4.
- Background: PubMed 29361852Toivonen KI, Tamagawa R, Speca M, Stephen J, Carlson LE. Open to Exploration? Association of Personality Factors With Complementary Therapy Use After Breast Cancer Treatment. Integr Cancer Ther. 2018 Sep;17(3):785-792. doi: 10.1177/1534735417753539. Epub 2018 Jan 24.
- Background: PubMed 21946880Szymlek-Gay EA, Richards R, Egan R. Physical activity among cancer survivors: a literature review. N Z Med J. 2011 Jun 24;124(1337):77-89.
- Background: PubMed 20052559Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6.
- Background: PubMed 25511250Meneses-Echavez JF, Gonzalez-Jimenez E, Ramirez-Velez R. Supervised exercise reduces cancer-related fatigue: a systematic review. J Physiother. 2015 Jan;61(1):3-9. doi: 10.1016/j.jphys.2014.08.019. Epub 2014 Dec 13.
- Background: PubMed 12547047Fortner BV, Stepanski EJ, Wang SC, Kasprowicz S, Durrence HH. Sleep and quality of life in breast cancer patients. J Pain Symptom Manage. 2002 Nov;24(5):471-80. doi: 10.1016/s0885-3924(02)00500-6.
- Background: PubMed 25307946Costa AR, Fontes F, Pereira S, Goncalves M, Azevedo A, Lunet N. Impact of breast cancer treatments on sleep disturbances - A systematic review. Breast. 2014 Dec;23(6):697-709. doi: 10.1016/j.breast.2014.09.003. Epub 2014 Oct 11.
- Background: PubMed 16155782Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.
- Background: PubMed 18653703Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24.
- The website of the CATCH projectLink provided by the sponsor.
- Information about our research facilityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All Individual Participant Data (IPD) will be shared as open research data after the results have been published. All data that might identify individuals will be stripped to make sure the data is completely anonymous.
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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.
Syed Abdul Shabbir, Dr. MD principal investigator
Associate Professor & Health IT Consultant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm of Breast (Disorder) and Carcinoma of Prostate (Disorder), run by Taipei Medical University at 2 sites in Taiwan.
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 9 inclusion and 7 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 will be assessed on the quality of life of breast and prostate cancer patients. (time frame: The time frame will be 8th day after enrolment of each respondent). 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?
On the ClinicalTrials.gov record for NCT03475433, which also lists 12 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 10 Apr 2019.