Prostate CancerSCPNCT04350788
Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program
A study testing Survivorship Care Plan and Enhanced Survivorship Care Plan in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Survivorship Care Plan and Enhanced Survivorship Care Plan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 15 Apr 2019
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility included men who:
- were diagnosed with localized PC;
- were within 16 weeks of completing their initial curative intent treatment [26] at genitourinary and radiation oncology clinics at two comprehensive cancer centers in the U.S southeast;
- were not treated for another cancer in last year; and
- had a partner > 18 years of age not receiving cancer treatment.
Who cannot join
- Either member of couple unable to speak English
- Unwilling/unable to provide Informed Consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559
About this study
The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners.
Participation of this study lasts for about for 16 weeks. Depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer.
Eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer education program, PERC) groups. They complete baseline (T1, prior to randomization) and 4-month post-T1 follow-up measures (T2).
Read the detailed description
Methods: A two-group randomized controlled pretest-posttest design will be used and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, the investigators will assess the feasibility of ESCP by recruitment, enrollment, and retention rates, program satisfaction with the ESCP, and perceived ease of use of the ESCP. To achieve the secondary aim, the ESCP users will be compared with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL), secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms), and number of visits to post-treatment care services at T1 and T2. The primary and secondary outcomes are assessed using measurements with sound psychometrical properties. The investigators will use a qualitative and quantitative mixed methods approach to achieve the research aims.
Conclusions: The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.
- Conditions
- Prostate Cancer
- Being tested
- Survivorship Care Plan, Enhanced Survivorship Care Plan
- Keywords
- survivorship care plan, quality of life, supportive care
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Care PlanOther
Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care
Enhanced Survivorship Care PlanOther
In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support
| Study group | Role | What they receive |
|---|---|---|
| Survivorship Care Plan (SCP) | Placebo comparator | The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate), Receives: Other: Survivorship Care Plan |
| Enhanced SCP (ESCP) | Experimental | ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home. Receives: Other: Enhanced Survivorship Care Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Potentially Eligible Participants Actually Enrolled Into the Study
Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study
Measured: after participants completed baseline survey
Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey
Will evaluate the percentage of participants successfully following protocol, defined as completing the Follow-Up survey at the end of the study period among those who have been enrolled into the study (who completed the baseline).
Measured: during 4-month study period
Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms
The usage of Web-Based Intervention Sessions is determined by the percentage of participants who logged into the study website among those who have been randomly assigned to the intervention group. Patient-Reported Symptoms are determined by patient's responses on their appraisal of prostate cancer symptoms and general symptoms. 1=patient reported the symptom and the symptom webpage reviewed; 0=patient reported the symptom and no related webpage reviewed OR patient did not report the symptom but the webpage reviewed
Measured: during 4-month study period
Participant Satisfaction Scores
Program satisfaction determined by the 11-item Participant Satisfaction Scale measured the level of program satisfaction. The first to tenth items ranged from 1=not satisfied to 5=extremely satisfied. The eleventh item ranged from 1=extremely not to 4=definitely yes. Higher total score indicates greater program satisfaction
Measured: at the 4 month followup
Perceived Ease of Use Score
The 16-item Program Usability measures participants' assessment of their agreement with the ease of use of the program in terms of its general features, content, and navigation. The ranges of the total scores are (3,15), (4,20), (9,45) for general features, content, and navigation, respectively. The score of individual item ranges from1=strongly disagree to 5=strongly agree. Higher score indicates greater perceived ease of use.
Measured: at the 4 month followup
Secondary outcomes (10)
Change in FACT-G Scores
Change in QOL determined using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change from baseline is the post-Baseline values minus the Baseline value.
Measured: Baseline upon enrollment, Month 4
Change in Appraisal of Prostate Cancer-Specific Symptoms
The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in appraisal of symptoms scores among patients from Baseline (T1) to T2 (4 months post T1). EPIC contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing opposite results by role: patient with better appraisal of symptoms and partner with worse appraisal of symptoms. Change from baseline is the post-Baseline values minus the Baseline value.
Measured: Baseline upon enrollment, Month 4
Change in Appraisal of General Symptoms
The 19-item Risk for Distress-general symptoms is a subscale of the Risk for Distress Scale. It measures how much trouble the participant has with the general symptoms such as pain, fatigue, and etc. The total score ranges between 0 and 38, with higher scores indicating worse appraisal of symptoms. Change from baseline is the post-Baseline values minus the Baseline value.
Measured: Baseline upon enrollment, Month 4
Healthcare Utilization Extracted From Electronic Medical Record
The total number of prostate cancer-related followup visits, emergency room use and readmissions.
Measured: during the first 10 months after participants completed baseline survey
Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline
The Lewis Cancer Self-Efficacy used to measure change in participants' feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1). Participants rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.
Measured: Baseline upon enrollment, Month 4
Change in PROMIS Social Support-Informational Support From Baseline to 4-Months Post-Baseline
The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more informational support. Change from baseline is the post-Baseline values minus the Baseline value.
Measured: Baseline upon enrollment, Month 4
Change in PROMIS Social Support-Emotional Support From Baseline to 4-months Post-Baseline
The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more emotional social support. Change from baseline is the post-Baseline values minus the Baseline value.
Measured: Baseline upon enrollment, Month 4
Change in PROMIS Social Support-Instrumental Support From Baseline to 4-months Post-Baseline
The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more instrumental support. Change from baseline is the post-Baseline values minus the Baseline value.
Measured: Baseline upon enrollment, Month 4
Change in Dietary Risk Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
Change in Dietary Risk Assessment scores used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants are asked how often they consume different foods over the past month or week and respond using a Likert Scale ranging from 1=never to 4=routinely. The total score range: 8-32. Higher scores indicate better health behaviors in nutrition.
Measured: Baseline upon enrollment, Month 4
Change in Physical Activity Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
Change in Physical Activity Assessment scores used to measure changes in physical activity from Baseline (T1) to T2 (4 months post T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants are asked how often they engage in exercises and physical activity over the past month or week and respond using a Likert Scale, ranging from 1=never to 4=routinely. The total score range: 9-36. Higher scores indicate better health behaviors in physical activity.
Measured: Baseline upon enrollment, Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start3 Aug 2017
- Primary completion30 Nov 2018
- Study completion15 Apr 2019
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lixin Song, RN, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350788
- Sponsor's protocol ID
- LCCC 1619
- Other IDs
- 1R21CA212516
- Acronym
- SCP
- Status last verified
- Sep 2020
- First submitted
- 28 Mar 2020
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Song L, Guo P, Tan X, Chen RC, Nielsen ME, Birken SA, Koontz BF, Northouse LL, Mayer DK. Enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study. J Cancer Surviv. 2021 Feb;15(1):99-108. doi: 10.1007/s11764-020-00914-7. Epub 2020 Jul 17.
PubMed 32681304
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program
- ClinicalTrials.gov ID
- NCT04350788
- Acronym / sponsor ID
- SCP / LCCC 1619
- Conditions
- Prostate Cancer
- Keywords
- survivorship care plan, quality of life, supportive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Posted 23 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners.
Participation of this study lasts for about for 16 weeks. Depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer.
Eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer education program, PERC) groups. They complete baseline (T1, prior to randomization) and 4-month post-T1 follow-up measures (T2).
Detailed description
Methods: A two-group randomized controlled pretest-posttest design will be used and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, the investigators will assess the feasibility of ESCP by recruitment, enrollment, and retention rates, program satisfaction with the ESCP, and perceived ease of use of the ESCP. To achieve the secondary aim, the ESCP users will be compared with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL), secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms), and number of visits to post-treatment care services at T1 and T2. The primary and secondary outcomes are assessed using measurements with sound psychometrical properties. The investigators will use a qualitative and quantitative mixed methods approach to achieve the research aims.
Conclusions: The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivorship Care Plan (SCP) | Placebo comparator | Other: Survivorship Care PlanThe SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate), |
| Enhanced SCP (ESCP) | Experimental | Other: Enhanced Survivorship Care PlanESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- were diagnosed with localized PC;
- were within 16 weeks of completing their initial curative intent treatment [26] at genitourinary and radiation oncology clinics at two comprehensive cancer centers in the U.S southeast;
- were not treated for another cancer in last year; and
- had a partner > 18 years of age not receiving cancer treatment.
Key exclusion criteria (2 listed)
- Either member of couple unable to speak English
- Unwilling/unable to provide Informed Consent
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 |
|---|---|---|
| Survivorship Care PlanParticipants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care | Other | Survivorship Care Plan (SCP) |
| Enhanced Survivorship Care PlanIn addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support | Other | Enhanced SCP (ESCP) |
Primary outcome
Percentage of Potentially Eligible Participants Actually Enrolled Into the Study
Time frame: after participants completed baseline survey
Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study
Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey
Time frame: during 4-month study period
Will evaluate the percentage of participants successfully following protocol, defined as completing the Follow-Up survey at the end of the study period among those who have been enrolled into the study (who completed the baseline).
Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms
Time frame: during 4-month study period
The usage of Web-Based Intervention Sessions is determined by the percentage of participants who logged into the study website among those who have been randomly assigned to the intervention group. Patient-Reported Symptoms are determined by patient's responses on their appraisal of prostate cancer symptoms and general symptoms. 1=patient reported the symptom and the symptom webpage reviewed; 0=patient reported the symptom and no related webpage reviewed OR patient did not report the symptom but the webpage reviewed
Participant Satisfaction Scores
Time frame: at the 4 month followup
Program satisfaction determined by the 11-item Participant Satisfaction Scale measured the level of program satisfaction. The first to tenth items ranged from 1=not satisfied to 5=extremely satisfied. The eleventh item ranged from 1=extremely not to 4=definitely yes. Higher total score indicates greater program satisfaction
Perceived Ease of Use Score
Time frame: at the 4 month followup
The 16-item Program Usability measures participants' assessment of their agreement with the ease of use of the program in terms of its general features, content, and navigation. The ranges of the total scores are (3,15), (4,20), (9,45) for general features, content, and navigation, respectively. The score of individual item ranges from1=strongly disagree to 5=strongly agree. Higher score indicates greater perceived ease of use.
10 secondary outcomes
Change in FACT-G Scores
Time frame: Baseline upon enrollment, Month 4
Change in Appraisal of Prostate Cancer-Specific Symptoms
Time frame: Baseline upon enrollment, Month 4
Change in Appraisal of General Symptoms
Time frame: Baseline upon enrollment, Month 4
Healthcare Utilization Extracted From Electronic Medical Record
Time frame: during the first 10 months after participants completed baseline survey
Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline
Time frame: Baseline upon enrollment, Month 4
Change in PROMIS Social Support-Informational Support From Baseline to 4-Months Post-Baseline
Time frame: Baseline upon enrollment, Month 4
Change in PROMIS Social Support-Emotional Support From Baseline to 4-months Post-Baseline
Time frame: Baseline upon enrollment, Month 4
Change in PROMIS Social Support-Instrumental Support From Baseline to 4-months Post-Baseline
Time frame: Baseline upon enrollment, Month 4
Change in Dietary Risk Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
Time frame: Baseline upon enrollment, Month 4
Change in Physical Activity Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
Time frame: Baseline upon enrollment, Month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32681304Song L, Guo P, Tan X, Chen RC, Nielsen ME, Birken SA, Koontz BF, Northouse LL, Mayer DK. Enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study. J Cancer Surviv. 2021 Feb;15(1):99-108. doi: 10.1007/s11764-020-00914-7. Epub 2020 Jul 17.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Lixin Song, RN, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Care Plan and Enhanced Survivorship Care Plan in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 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 23 Sep 2020. 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. Some participants in this study may receive a placebo. 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 23 Sep 2020). 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?
Percentage of Potentially Eligible Participants Actually Enrolled Into the Study (time frame: after participants completed baseline survey). The study lists 5 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 NCT04350788, 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 23 Sep 2020.