Cancer SurvivorNCT02699983
eHealth Weight Loss Program in African American Breast Cancer Survivors
A study testing Behavioral Dietary Intervention, Exercise Intervention and Activity Monitoring Device in people with Cancer Survivor and Stage IA Breast Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies how well a virtual weight loss program (SparkPeople) works in helping female African American breast cancer survivors maintain a healthy weight. Many patients with breast cancer are overweight or gain weight after diagnosis. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Cancer Survivor, Stage IA Breast Cancer, Stage IB Breast Cancer
- What is being tested?
- Behavioral Dietary Intervention, Exercise Intervention and Activity Monitoring Device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2016to 29 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have evidence of histologically confirmed breast cancer, stage 0, I, II or III, and be at least 2 years post diagnosis
- Patient is self-identified as African-American
- Patient is overweight or obese (body mass index [BMI] >= 25 kg/m^2)
- Patient is able to understand and read English
- Patient must have home internet or smartphone access
- Patient must give informed consent for this new study
Who cannot join
- Patient has a serious medical condition (e.g., stroke, liver or renal failure, congestive heart failure, myocardial infarction or cardiac surgery in past year, angina pectoris) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
- Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or other psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or current active suicidal ideation) that would compromise the patient's ability to complete the study, at the discretion of the investigator
- Patient has severe disabilities limiting moderate physical activity, such as severe orthopedic conditions
- Patient is planning major surgery within the next 6 months
- Patient is taking medications or supplements for weight loss currently or within the past 3 months
- Patient has successfully lost 5% of body weight in the previous 6 months or has had bariatric surgery
- Patient is pregnant, breastfeeding, has given birth within the last 3 months or planning pregnancy within the next 12 months; if participant becomes pregnant during the course of the study, she will be removed from further participation
- Patient is anticipating leaving the area within the next 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: Virtual Weight Loss Program for African-American Breast Cancer Survivors
This randomized pilot clinical trial studies how well a virtual weight loss program (SparkPeople) works in helping female African American breast cancer survivors maintain a healthy weight. Many patients with breast cancer are overweight or gain weight after diagnosis. SparkPeople is a free web-based weight loss program that features educational and motivational articles and videos, self-monitoring tools, incentives, social support communities (including discussion forums, teams, challenges, and expert blogs), and options for content to be delivered to members' email. It is a comprehensive program that includes advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet and exercise), and emphasizes safe weight loss and receiving medical attention regularly when needed. A web-based program such as SparkPeople may help breast cancer survivors maintain a healthy weight, which may reduce the risk of cancer returning and patient fatigue, and improve patient quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine feasibility of using a free online commercial weight loss program (SparkPeople) in African-American (AA) breast cancer survivors, as measured by: 1) Accrual: percent (%) patients recruited and completing baseline assessments; 2) Study retention: % patients completing 6 month follow-up assessment; 3) Intervention adherence and sustainability (measured at 3, 6, 12 months): a) use of website- number of log-ins, time spent, and use of features such as food diaries, joining teams, posting on message boards (provided by SparkPeople); b) use of Fitbit monitor- % patients who wore the monitor and synced data; c) satisfaction (e.g., ease of use of website, usefulness of content, extra training and support needed) and barriers to participation (e.g., lack of computer access, lack of skills, time, interest, etc.).
SECONDARY OBJECTIVES:
- Collect preliminary data on effect sizes of changes in our outcomes and potential mediators associated with the use of the online weight loss program.
OUTLINE: Patients are randomized to 1 of 2 groups.
All patients receive a handout of their personalized goals for weight loss, diet, and physical activity, with instructions to proceed slowly and as tolerated. Patients also wear a Fitbit monitoring device to monitor physical activity levels daily.
GROUP I: Patients receive one 30-minute session with the research assistant for training on how to use the SparkPeople website, and may request additional training if needed. Patients are instructed to self-monitor their diet at least weekly using SparkPeople and physical activity levels daily using the Fitbit monitoring device, which integrates with the SparkPeople program. Patients receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Patients then enter the maintenance phase for an additional 3 months without reminders.
GROUP II: Patients receive the weight loss handout and a Fitbit health monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
- Conditions
- Cancer Survivor, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
- Being tested
- Behavioral Dietary Intervention, Exercise Intervention, Activity Monitoring Device
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Dietary InterventionBehavioural
Use SparkPeople web-based program
Exercise InterventionBehavioural
Use Fitbit monitor and SparkPeople web-based program
Activity Monitoring DeviceDevice
Also called Monitor
Wear Fitbit activity monitoring device
| Study group | Role | What they receive |
|---|---|---|
| Group I (SparkPeople program) | Experimental | Participants receive one 30-minute session with the research assistant for training on how to use the SparkPeople website, and they may request additional training if needed.
Participants are instructed to self-monitor their diet at least weekly using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.
Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.
All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3, and 6 months. Receives: Behavioral: Behavioral Dietary Intervention; Behavioral: Exercise Intervention; Device: Activity Monitoring Device |
| Group II (wait list) | Active comparator | Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3 and 6 months. Receives: Device: Activity Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.
Measured: 12 months
Retention Rate
Number of participants completing study. Feasibility will be defined as >= 80% retention rate.
Measured: 6 months
Adherence to SparkPeople- Logged in
average number of days logged per week in to SparkPeople website
Measured: 0-3 months after intervention
Adherence to SparkPeople- Logged in
Average number of days per week logged in to SparkPeople website
Measured: 4-6 months after intervention
Adherence to SparkPeople- Logged Food
Average number of days per week logged food into SparkPeople
Measured: 0-3 months after intervention
Adherence to SparkPeople- Logged Food
Average number of days per week logged food into SparkPeople
Measured: 4-6 months after intervention
Acceptability of SparkPeople
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Measured: 0-3 months after intervention
Acceptability of SparkPeople
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Measured: 4-6 months after intervention
Adherence to Fitbit
average days used Fitbit per week
Measured: 0-3 months after intervention
Adherence to Fitbit
average days used Fitbit per week
Measured: 4-6 months after intervention
Acceptability of Fitbit
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Measured: 0-3 months after intervention
Acceptability of Fitbit
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Measured: 4-6 months after intervention
Secondary outcomes (16)
Change in Weight
Change in weight from baseline
Measured: baseline and 3 months
Change in Weight
Change in weight from baseline
Measured: baseline and 6 months
Change in Waist Circumference
Change in waist circumference from baseline
Measured: baseline and 3 months
Change in Waist Circumference
Change in waist circumference from baseline
Measured: baseline and 6 months
Change in Caloric Intake
Changes in caloric intake per day, measured by 24-hour recall
Measured: baseline and 3 months
Change in Caloric Intake
Changes in caloric intake per day, measured by 24-hour recall
Measured: baseline and 6 months
Change in Physical Activity
change in average number of steps per day measured using Fitbit monitor
Measured: baseline and 3 months
Change in Physical Activity
change in average number of steps per day measured using Fitbit monitor
Measured: baseline and 6 months
Cardiopulmonary Fitness
change in fitness, measured by the 6-minute walk test
Measured: baseline and 3 months
Cardiopulmonary Fitness
change in fitness, measured by the 6-minute walk test
Measured: baseline and 6 months
Change in Quality of Life
measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life
Measured: baseline and 3 months
Change in Quality of Life
measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life
Measured: baseline and 6 months
Self-efficacy, Eating Healthy Foods
change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)
Measured: baseline and 3 months
Self-efficacy, Eating Healthy Foods
change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)
Measured: baseline and 6 months
Social Support for Healthy Nutrition
change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome
Measured: baseline and 3 months
Social Support for Healthy Nutrition
change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start8 Jan 2016
- Primary completion20 Jul 2018
- Study completion29 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jeanne M. Ferrante, MD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Jeanne Ferrante, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699983
- Sponsor's protocol ID
- Pro20150001595
- Other IDs
- NCI-2015-02137, Pro20150001595, 131404, R21CA191431
- Status last verified
- Apr 2021
- First submitted
- 1 Mar 2016
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferrante JM, Devine KA, Bator A, Rodgers A, Ohman-Strickland PA, Bandera EV, Hwang KO. Feasibility and potential efficacy of commercial mHealth/eHealth tools for weight loss in African American breast cancer survivors: pilot randomized controlled trial. Transl Behav Med. 2020 Oct 8;10(4):938-948. doi: 10.1093/tbm/iby124.
PubMed 30535101
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Weight Loss Program for African-American Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02699983
- Acronym / sponsor ID
- Pro20150001595
- Conditions
- Cancer Survivor, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 29 Jul 2018 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Posted 6 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot clinical trial studies how well a virtual weight loss program (SparkPeople) works in helping female African American breast cancer survivors maintain a healthy weight. Many patients with breast cancer are overweight or gain weight after diagnosis. SparkPeople is a free web-based weight loss program that features educational and motivational articles and videos, self-monitoring tools, incentives, social support communities (including discussion forums, teams, challenges, and expert blogs), and options for content to be delivered to members' email. It is a comprehensive program that includes advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet and exercise), and emphasizes safe weight loss and receiving medical attention regularly when needed. A web-based program such as SparkPeople may help breast cancer survivors maintain a healthy weight, which may reduce the risk of cancer returning and patient fatigue, and improve patient quality of life.
Detailed description
PRIMARY OBJECTIVES:
- Determine feasibility of using a free online commercial weight loss program (SparkPeople) in African-American (AA) breast cancer survivors, as measured by: 1) Accrual: percent (%) patients recruited and completing baseline assessments; 2) Study retention: % patients completing 6 month follow-up assessment; 3) Intervention adherence and sustainability (measured at 3, 6, 12 months): a) use of website- number of log-ins, time spent, and use of features such as food diaries, joining teams, posting on message boards (provided by SparkPeople); b) use of Fitbit monitor- % patients who wore the monitor and synced data; c) satisfaction (e.g., ease of use of website, usefulness of content, extra training and support needed) and barriers to participation (e.g., lack of computer access, lack of skills, time, interest, etc.).
SECONDARY OBJECTIVES:
- Collect preliminary data on effect sizes of changes in our outcomes and potential mediators associated with the use of the online weight loss program.
OUTLINE: Patients are randomized to 1 of 2 groups.
All patients receive a handout of their personalized goals for weight loss, diet, and physical activity, with instructions to proceed slowly and as tolerated. Patients also wear a Fitbit monitoring device to monitor physical activity levels daily.
GROUP I: Patients receive one 30-minute session with the research assistant for training on how to use the SparkPeople website, and may request additional training if needed. Patients are instructed to self-monitor their diet at least weekly using SparkPeople and physical activity levels daily using the Fitbit monitoring device, which integrates with the SparkPeople program. Patients receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Patients then enter the maintenance phase for an additional 3 months without reminders.
GROUP II: Patients receive the weight loss handout and a Fitbit health monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (SparkPeople program) | Experimental | Behavioral: Behavioral Dietary Intervention, Behavioral: Exercise Intervention, Device: Activity Monitoring DeviceParticipants receive one 30-minute session with the research assistant for training on how to use the SparkPeople website, and they may request additional training if needed. Participants are instructed to self-monitor their diet at least weekly using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3, and 6 months. |
| Group II (wait list) | Active comparator | Device: Activity Monitoring DeviceParticipants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3 and 6 months. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have evidence of histologically confirmed breast cancer, stage 0, I, II or III, and be at least 2 years post diagnosis
- Patient is self-identified as African-American
- Patient is overweight or obese (body mass index [BMI] >= 25 kg/m^2)
- Patient is able to understand and read English
- Patient must have home internet or smartphone access
Key exclusion criteria (8 listed)
- Patient has a serious medical condition (e.g., stroke, liver or renal failure, congestive heart failure, myocardial infarction or cardiac surgery in past year, angina pectoris) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
- Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or other psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or current active suicidal ideation) that would compromise the patient's ability to complete the study, at the discretion of the investigator
- Patient has severe disabilities limiting moderate physical activity, such as severe orthopedic conditions
- Patient is planning major surgery within the next 6 months
- Patient is taking medications or supplements for weight loss currently or within the past 3 months
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 |
|---|---|---|
| Behavioral Dietary InterventionUse SparkPeople web-based program | Behavioural | Group I (SparkPeople program) |
| Exercise InterventionUse Fitbit monitor and SparkPeople web-based program | Behavioural | Group I (SparkPeople program) |
| Activity Monitoring DeviceAlso: MonitorWear Fitbit activity monitoring device | Device | Group I (SparkPeople program), Group II (wait list) |
Primary outcome
Recruitment Rate
Time frame: 12 months
Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.
Retention Rate
Time frame: 6 months
Number of participants completing study. Feasibility will be defined as >= 80% retention rate.
Adherence to SparkPeople- Logged in
Time frame: 0-3 months after intervention
average number of days logged per week in to SparkPeople website
Adherence to SparkPeople- Logged in
Time frame: 4-6 months after intervention
Average number of days per week logged in to SparkPeople website
Adherence to SparkPeople- Logged Food
Time frame: 0-3 months after intervention
Average number of days per week logged food into SparkPeople
Adherence to SparkPeople- Logged Food
Time frame: 4-6 months after intervention
Average number of days per week logged food into SparkPeople
Acceptability of SparkPeople
Time frame: 0-3 months after intervention
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Acceptability of SparkPeople
Time frame: 4-6 months after intervention
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Adherence to Fitbit
Time frame: 0-3 months after intervention
average days used Fitbit per week
Adherence to Fitbit
Time frame: 4-6 months after intervention
average days used Fitbit per week
Acceptability of Fitbit
Time frame: 0-3 months after intervention
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Acceptability of Fitbit
Time frame: 4-6 months after intervention
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
16 secondary outcomes
Change in Weight
Time frame: baseline and 3 months
Change in Weight
Time frame: baseline and 6 months
Change in Waist Circumference
Time frame: baseline and 3 months
Change in Waist Circumference
Time frame: baseline and 6 months
Change in Caloric Intake
Time frame: baseline and 3 months
Change in Caloric Intake
Time frame: baseline and 6 months
Change in Physical Activity
Time frame: baseline and 3 months
Change in Physical Activity
Time frame: baseline and 6 months
Cardiopulmonary Fitness
Time frame: baseline and 3 months
Cardiopulmonary Fitness
Time frame: baseline and 6 months
Change in Quality of Life
Time frame: baseline and 3 months
Change in Quality of Life
Time frame: baseline and 6 months
Self-efficacy, Eating Healthy Foods
Time frame: baseline and 3 months
Self-efficacy, Eating Healthy Foods
Time frame: baseline and 6 months
Social Support for Healthy Nutrition
Time frame: baseline and 3 months
Social Support for Healthy Nutrition
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30535101Ferrante JM, Devine KA, Bator A, Rodgers A, Ohman-Strickland PA, Bandera EV, Hwang KO. Feasibility and potential efficacy of commercial mHealth/eHealth tools for weight loss in African American breast cancer survivors: pilot randomized controlled trial. Transl Behav Med. 2020 Oct 8;10(4):938-948. doi: 10.1093/tbm/iby124.
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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.
Jeanne Ferrante principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Dietary Intervention, Exercise Intervention and Activity Monitoring Device in people with Cancer Survivor and Stage IA Breast Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 6 inclusion and 8 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 13 Apr 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment Rate (time frame: 12 months). The study lists 12 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 NCT02699983, which also lists 1 linked publication.
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 13 Apr 2021.