Endometrial NeoplasmsDEUSNCT02433080
Diet and Physical Activity in Uterine Cancer Survivors
A study testing Shape-Up following cancer treatment in people with Endometrial Neoplasms, run by University College, London at 2 sites in United Kingdom.
Trial summary
Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms
- What is being tested?
- Shape-Up following cancer treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2015to Jun 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged >18 years (no upper age limit)
- Women diagnosed with endometrial cancer (C54.1) within the previous 36 months
- Women who are able to understand spoken and written English
Who cannot join
- Women with stage IVB (metastatic) endometrial cancer (any metastasis beyond the pelvis)
- Women on active anti-cancer, and/or palliative treatment,
- Women having second primary cancer
- Women who lack mental capacity to decide to take part in the study and to participate in it (upon clinical team's judgement in accordance with the Mental Capacity Act 2005 Code of Practice 2007)
- Women with severe depression (upon consultant's judgement based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria)
- Women unavailable for longitudinal follow-up assessments
- Women who participated in a professionally delivered weight loss or exercise program during the previous 6 months
- Women with a World Health Organization performance score 3-4
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Barts Health NHS Trust
London, Greater London, E1 1BB
University College London Hospital NHS Trust
London, Greater London, NW1 3AD
About this study
Official title: Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point.
This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.
Read the detailed description
Low physical activity, poor diet and obesity are risk factors for the development of endometrial cancer. A growing body of evidence suggests that they may be linked with quality of life after cancer treatment. However, only about 1% of endometrial cancer survivors seem to meet the current fruit and vegetable, physical activity, and non-smoking recommendations; while 57% meets only the non-smoking recommendations, and 22% meet none of the recommendations,
These behaviours exist despite cancer diagnosis being perceived as a "teachable moment". Capitalising the "teachable moment" of cancer, behaviour change interventions in high-risk populations might be more effective than those targeting the general population.
Theory-based behaviour change interventions suggest that improving diet and physical activity is safe, acceptable, and feasible and can help cancer survivors improve their quality of life. In contrast, there are only limited studies to support these data in the United Kingdom to allow generalisability of these results. However, the majority of these interventions were long-term and resource intensive which may render them inappropriate for wide dissemination. Therefore, feasible and effective interventions are needed to promote implementation of the nutrition and physical activity guidelines.
The intervention is based on the Shape-Up eight-week weight management programme. This programme is based on "Social Cognitive Theory" and "Control Theory". A version of this program has been favourably evaluated in terms of acceptability, physical, and psychological outcomes. We have tailored this programme (Shape-Up following cancer treatment) to help endometrial cancer survivors improve their diet, and activity pattern. The focus of the programme lies on self-control, self-efficacy, and relapse prevention in terms of healthy eating and physical activity. Behavioural techniques will include self-monitoring of behaviour with the use of food and physical activity diaries, behavioural goal setting, action planning, graded tasks, problem solving, self-reward, and review of behavioural goals. It will also provide information about health consequences and emotional consequences, pros and cons, behavioural practice, habit formation, reducing exposure to cues for the behaviour, behaviour substitution, distraction, social support (unspecified), demonstration of behaviour (for resistance exercises), instructions on how to perform the behaviour (for resistance exercises), and reframing.
The DEUS pilot trial is an eight-week, two-arm, individually randomised, controlled pilot trial comparing the use of the "Shape-Up following cancer treatment" programme to usual care. According to Medical Research Council guidance for complex interventions, this is a Phase 2 feasibility study. Randomisation will be performed with minimisation using a 1:1 allocation.
- Conditions
- Endometrial Neoplasms
- Being tested
- Shape-Up following cancer treatment
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shape-Up following cancer treatmentBehavioural
Also called Self-help healthy eating and physical activity programme
The programme is based on "Social Cognitive Theory" and "Control Theory". The focus of the programme lies on self-control, self-efficacy, and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Shape-Up following cancer treatment | Active comparator | In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called "Shape-Up following cancer treatment: a self-help programme on eating well and being active". Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group. Receives: Behavioral: Shape-Up following cancer treatment |
| Control intervention | No intervention | Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment. During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study)
Achieving a 30% recruitment rate of the potentially eligible participants
Measured: 6 months
Secondary outcomes (11)
Change From Baseline in Health-related Quality of Life Score
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 \& European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module 24 Global quality of life scale ranging from 0-100 with higher scores indicating better quality of life
Measured: Baseline, 8weeks, 24weeks
Change From Baseline in Dietary Quality (24-h Dietary Recall)
One 24-h dietary recall for each timepoint. This is the combined total Alternate healthy eating index-2010 score ranging from 0-110 with higher scores indicating higher dietary quality.
Measured: Baseline, 8weeks, 24weeks
Change From Baseline in Physical Activity (Physical Activity Recall)
7-day physical activity recall
Measured: Baseline, 8weeks, 24weeks
Change From Baseline in Hand-grip Strength
Measured: Baseline, 8weeks, 24weeks
Change From Baseline in Weight
Measured: Baseline, 8weeks, 24weeks
Change From Baseline in Fat Mass Index
Using MC980 multi-frequency segmental body composition analyser. Fat mass index was calculated as kg of fat mass divided by squared height in meters.
Measured: Baseline, 8weeks, 24weeks
Intervention Evaluation Questionnaire
Change in the self-assessment of the gained skills (Shape-Up self-efficacy score). This is a total score 0-5 with higher scores indicating higher self-efficacy.
Measured: 8weeks, 24weeks
Health Care Services Use - Medication
Number of currently prescribed medications over the 24 weeks of the trial (Self-reported)
Measured: 24weeks
Adherence Rate
The percentage of engaged participants attending at least one of the last three sessions of the intervention. Engaged participants are those who have attended at least two sessions of the intervention.
Measured: 8 weeks
Retention Rate
Rate of complete follow-up
Measured: Baseline to 24weeks
Health Care Services Use - Number of General Practitioner Visits
Number of visits to their general practitioner over the 24 weeks of the trial (Self-reported)
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionJun 2016
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 (5)Papers the sponsor has linked to this study.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Lanceley, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433080
- Sponsor's protocol ID
- 14/0765
- Acronym
- DEUS
- Status last verified
- May 2020
- First submitted
- 20 Apr 2015
- Last updated
- 19 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, Stampfer MJ, Willett WC. Alternative dietary indices both strongly predict risk of chronic disease. J Nutr. 2012 Jun;142(6):1009-18. doi: 10.3945/jn.111.157222. Epub 2012 Apr 18.
PubMed 22513989Koutoukidis DA, Lopes S, Atkins L, Croker H, Knobf MT, Lanceley A, Beeken RJ. Use of intervention mapping to adapt a health behavior change intervention for endometrial cancer survivors: the shape-up following cancer treatment program. BMC Public Health. 2018 Mar 27;18(1):415. doi: 10.1186/s12889-018-5329-5.
PubMed 29587699Koutoukidis DA, Beeken RJ, Manchanda R, Burnell M, Ziauddeen N, Michalopoulou M, Knobf MT, Lanceley A. Diet, physical activity, and health-related outcomes of endometrial cancer survivors in a behavioral lifestyle program: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomized controlled pilot trial. Int J Gynecol Cancer. 2019 Mar;29(3):531-540. doi: 10.1136/ijgc-2018-000039. Epub 2019 Feb 4.
PubMed 30723098Koutoukidis DA, Beeken RJ, Manchanda R, Michalopoulou M, Burnell M, Knobf MT, Lanceley A. Recruitment, adherence, and retention of endometrial cancer survivors in a behavioural lifestyle programme: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomised pilot trial. BMJ Open. 2017 Oct 8;7(10):e018015. doi: 10.1136/bmjopen-2017-018015.
PubMed 28993394Koutoukidis DA, Beeken RJ, Manchanda R, Burnell M, Knobf MT, Lanceley A. Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial. Trials. 2016 Mar 10;17(1):130. doi: 10.1186/s13063-016-1260-1.
PubMed 26965165
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT02433080
- Acronym / sponsor ID
- DEUS / 14/0765
- Conditions
- Endometrial Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Posted 19 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point.
This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.
Detailed description
Low physical activity, poor diet and obesity are risk factors for the development of endometrial cancer. A growing body of evidence suggests that they may be linked with quality of life after cancer treatment. However, only about 1% of endometrial cancer survivors seem to meet the current fruit and vegetable, physical activity, and non-smoking recommendations; while 57% meets only the non-smoking recommendations, and 22% meet none of the recommendations,
These behaviours exist despite cancer diagnosis being perceived as a "teachable moment". Capitalising the "teachable moment" of cancer, behaviour change interventions in high-risk populations might be more effective than those targeting the general population.
Theory-based behaviour change interventions suggest that improving diet and physical activity is safe, acceptable, and feasible and can help cancer survivors improve their quality of life. In contrast, there are only limited studies to support these data in the United Kingdom to allow generalisability of these results. However, the majority of these interventions were long-term and resource intensive which may render them inappropriate for wide dissemination. Therefore, feasible and effective interventions are needed to promote implementation of the nutrition and physical activity guidelines.
The intervention is based on the Shape-Up eight-week weight management programme. This programme is based on "Social Cognitive Theory" and "Control Theory". A version of this program has been favourably evaluated in terms of acceptability, physical, and psychological outcomes. We have tailored this programme (Shape-Up following cancer treatment) to help endometrial cancer survivors improve their diet, and activity pattern. The focus of the programme lies on self-control, self-efficacy, and relapse prevention in terms of healthy eating and physical activity. Behavioural techniques will include self-monitoring of behaviour with the use of food and physical activity diaries, behavioural goal setting, action planning, graded tasks, problem solving, self-reward, and review of behavioural goals. It will also provide information about health consequences and emotional consequences, pros and cons, behavioural practice, habit formation, reducing exposure to cues for the behaviour, behaviour substitution, distraction, social support (unspecified), demonstration of behaviour (for resistance exercises), instructions on how to perform the behaviour (for resistance exercises), and reframing.
The DEUS pilot trial is an eight-week, two-arm, individually randomised, controlled pilot trial comparing the use of the "Shape-Up following cancer treatment" programme to usual care. According to Medical Research Council guidance for complex interventions, this is a Phase 2 feasibility study. Randomisation will be performed with minimisation using a 1:1 allocation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shape-Up following cancer treatment | Active comparator | Behavioral: Shape-Up following cancer treatmentIn addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called "Shape-Up following cancer treatment: a self-help programme on eating well and being active". Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group. |
| Control intervention | No intervention | –Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment. During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged >18 years (no upper age limit)
- Women diagnosed with endometrial cancer (C54.1) within the previous 36 months
- Women who are able to understand spoken and written English
Key exclusion criteria (8 listed)
- Women with stage IVB (metastatic) endometrial cancer (any metastasis beyond the pelvis)
- Women on active anti-cancer, and/or palliative treatment,
- Women having second primary cancer
- Women who lack mental capacity to decide to take part in the study and to participate in it (upon clinical team's judgement in accordance with the Mental Capacity Act 2005 Code of Practice 2007)
- Women with severe depression (upon consultant's judgement based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria)
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 |
|---|---|---|
| Shape-Up following cancer treatmentAlso: Self-help healthy eating and physical activity programmeThe programme is based on "Social Cognitive Theory" and "Control Theory". The focus of the programme lies on self-control, self-efficacy, and relapse prevention. | Behavioural | Shape-Up following cancer treatment |
Primary outcome
Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study)
Time frame: 6 months
Achieving a 30% recruitment rate of the potentially eligible participants
11 secondary outcomes
Change From Baseline in Health-related Quality of Life Score
Time frame: Baseline, 8weeks, 24weeks
Change From Baseline in Dietary Quality (24-h Dietary Recall)
Time frame: Baseline, 8weeks, 24weeks
Change From Baseline in Physical Activity (Physical Activity Recall)
Time frame: Baseline, 8weeks, 24weeks
Change From Baseline in Hand-grip Strength
Time frame: Baseline, 8weeks, 24weeks
Change From Baseline in Weight
Time frame: Baseline, 8weeks, 24weeks
Change From Baseline in Fat Mass Index
Time frame: Baseline, 8weeks, 24weeks
Intervention Evaluation Questionnaire
Time frame: 8weeks, 24weeks
Health Care Services Use - Medication
Time frame: 24weeks
Adherence Rate
Time frame: 8 weeks
Retention Rate
Time frame: Baseline to 24weeks
Health Care Services Use - Number of General Practitioner Visits
Time frame: 24weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22513989Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, Stampfer MJ, Willett WC. Alternative dietary indices both strongly predict risk of chronic disease. J Nutr. 2012 Jun;142(6):1009-18. doi: 10.3945/jn.111.157222. Epub 2012 Apr 18.
- Background: PubMed 29587699Koutoukidis DA, Lopes S, Atkins L, Croker H, Knobf MT, Lanceley A, Beeken RJ. Use of intervention mapping to adapt a health behavior change intervention for endometrial cancer survivors: the shape-up following cancer treatment program. BMC Public Health. 2018 Mar 27;18(1):415. doi: 10.1186/s12889-018-5329-5.
- Derived from this study: PubMed 30723098Koutoukidis DA, Beeken RJ, Manchanda R, Burnell M, Ziauddeen N, Michalopoulou M, Knobf MT, Lanceley A. Diet, physical activity, and health-related outcomes of endometrial cancer survivors in a behavioral lifestyle program: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomized controlled pilot trial. Int J Gynecol Cancer. 2019 Mar;29(3):531-540. doi: 10.1136/ijgc-2018-000039. Epub 2019 Feb 4.
- Derived from this study: PubMed 28993394Koutoukidis DA, Beeken RJ, Manchanda R, Michalopoulou M, Burnell M, Knobf MT, Lanceley A. Recruitment, adherence, and retention of endometrial cancer survivors in a behavioural lifestyle programme: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomised pilot trial. BMJ Open. 2017 Oct 8;7(10):e018015. doi: 10.1136/bmjopen-2017-018015.
- Derived from this study: PubMed 26965165Koutoukidis DA, Beeken RJ, Manchanda R, Burnell M, Knobf MT, Lanceley A. Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial. Trials. 2016 Mar 10;17(1):130. doi: 10.1186/s13063-016-1260-1.
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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.
Anne Lanceley, PhD principal investigator
University College, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shape-Up following cancer treatment in people with Endometrial Neoplasms, run by University College, London at 2 sites in United Kingdom.
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 3 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 19 May 2020. 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 United Kingdom. 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 19 May 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?
Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (time frame: 6 months). 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 NCT02433080, which also lists 5 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 19 May 2020.