Pediatric CancerNCT05012917
Parent/Child Dyad Approach to Symptom Screening for Children With Cancer
A study testing Patient/Proxy-SSPedi and Co-SSPedi in people with Pediatric Cancer and Quality of Life, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Symptoms are common and often severely bothersome in pediatric patients receiving cancer treatments. In order to measure the extent of bothersome symptoms, the Symptom Screening in Pediatrics Tool (SSPedi) was developed. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pediatric Cancer, Quality of Life, Symptom Screening
- What is being tested?
- Patient/Proxy-SSPedi and Co-SSPedi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteCanada
- Study dates
- 19 Aug 2021to 3 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child and guardian both understand English
- Child is 4 to 18 years of age
- Child has diagnosis of cancer or is a hematopoietic stem cell transplant (HSCT) recipient
- Child is inpatient or outpatient
Who cannot join
- Participants who have illness severity,
- cognitive disability, or
- visual impairment that preclude utilization of co-SSPedi, SSPedi/mini-SSPedi or proxy SSPedi according to the primary healthcare team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial a Dyad Approach to Symptom Screening (Co-SSPedi) vs. Proxy-report (Proxy-SSPedi) and Self-report (SSPedi or Mini-SSPedi) for Pediatric Patients Receiving Cancer Treatments
Symptoms are common and often severely bothersome in pediatric patients receiving cancer treatments. In order to measure the extent of bothersome symptoms, the Symptom Screening in Pediatrics Tool (SSPedi) was developed. It is reliable, valid and responsive to change in pediatric patients aged 8-18 years receiving cancer treatments. Mini-SSPedi was developed for children 4-7 years and exhibits face and content validity. These instruments were developed to address the lack of appropriate symptom screening tools for this population. They are available in both self-report and proxy-report formats.
Differences between child self-report and parent proxy-report quality of life (QoL) scores have been well described in pediatric populations. There has been increasing recognition that each reporter may have unique and valid perspectives. This has led to a suggestion to collect both child and parent report when possible.
Read more
When used in clinical care, obtaining both child and parent report will commonly not be feasible. There are settings in which children will not be willing to independently report symptoms, such as when they are very ill. Unfortunately, it is particularly in this setting that obtaining symptoms reports is crucial. While young children may be able to independently report symptoms on a single occasion in the context of a carefully conducted research study, they are less likely to be able to repeatedly and independently report their symptoms. Finally, the burden and logistical complexity of separate child and parent reporting would be associated with considerable challenges for clinical implementation.
In considering how routine symptom screening could be implemented into clinical practice, we hypothesized that a dyad approach, where SSPedi is completed by both the child and parent together, may be one way to address these challenges. Consequently, we developed and finalized the approach to co-SSPedi administration, with instruction that is easy to understand, resulting in dyads completing co-SSPedi correctly.
To understand the relationships between the available forms of SSPedi (co-SSPedi, proxy-SSPedi and SSPedi), outstanding questions are how co-SSPedi scores compare to either proxy-report or self-report SSPedi and whether the co-SSPedi administration approach increases or decreases score variability. This study is designed to address these questions.
Read the detailed description
The overall goal of this randomized, cross-over study is to describe the distribution of co-SSPedi scores when compared to proxy-report and self-report SSPedi or mini-SSPedi scores. We hypothesize co-SSPedi would be significantly different than proxy-report and self-report SSPedi with respect to score distribution, and would have decreased symptom score variability.
Aim 1: To compare the mean co-SSPedi scores vs. proxy-SSPedi for pediatric patients with cancer or HSCT recipients who are 4-18 years of age.
Aim 2: To compare the mean co-SSPedi scores vs. self-report SSPedi/mini-SSPedi scores for pediatric patients with cancer or HSCT recipients who are 4-18 years of age.
Aim 3: To describe differences in interquartile range, standard deviation and range between co-SSPedi scores vs. proxy-report or self-report SSPedi/mini-SSPedi scores.
Aim 4: To obtain qualitative feedback about the experience of completing symptom screening together vs. separately from pediatric patients and their parents
Overall Strategy
This study is a randomized cross-over study that involves a single interview where the primary analysis will involve the first period only. This study will be conducted at a single center, The Hospital for Sick Children (SickKids) in Toronto. The study population will comprise participants across all oncology and HSCT sections within the Division of Haematology/Oncology.
Research Methods
Eligibility: This study will enroll child-parent dyads. We will include English-speaking dyads of a child and a guardian, where the child is between 4-18 years of age and has a diagnosis of cancer or is a hematopoietic stem cell transplant (HSCT) recipient. Exclusion criteria will be illness severity, cognitive disability or other impairment that precludes completion of co-SSPedi, SSPedi/mini-SSPedi or proxy SSPedi according to the primary healthcare team. Both inpatients and outpatients will be eligible.
Procedures: The instruments will be administered on an electronic platform. Each dyad will complete both co-SSPedi as one "period" and then self-report SSPedi/mini-SSPedi and proxy-SSPedi as a second "period". Both "periods" will occur during the same dyad encounter. The order of periods will be randomized, resulting in two groups based upon the approach used in the first period. The allocation sequence will be computer generated and will be concealed from all participants, healthcare providers and research team members. Consenting participants will be randomized 1:1 to co-SSPedi administration first vs. self-report/proxy-report first using permuted block sizes and stratified by relapse status (yes vs. no), age (4-7, 8-10, 11-14 and 15-18 years) and outpatient/ inpatient at time of interview as our previous data suggested that these factors were the most strongly associated with higher total SSPedi scores.
The dyad will complete the randomized approach first and then will proceed to the alternate approach. After the second period, qualitative feedback will be elicited using a semi-structured interview.
- Conditions
- Pediatric Cancer, Quality of Life, Symptom Screening
- Being tested
- Patient/Proxy-SSPedi, Co-SSPedi
- Keywords
- Pediatric Oncology, Randomized Controlled Trial, Symptom Screening, Quality of Life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient/Proxy-SSPediOther
SSPedi and Mini-SSPedi: SSPedi is a symptom assessment scale for children 8-18 years of age that includes 15 symptoms considered most important by children receiving cancer treatment or HSCT, their parents and healthcare professionals. Each symptom is rated on a 5-point Likert scale consisting of 0="not at all bothered", 1="a little", 2="medium", 3="a lot" and 4="extremely bothered". The recall period is yesterday or today.
Mini-SSPedi was developed for children 4-7 years of age and is comprised of the same 15 symptoms. Mini-SSPedi has a recall period of today with a 3-point Likert scale consisting of 0="not at all bothered", 2="medium" and 4="extremely bothered'. So, the anchors and mid-point are identical to SSPedi. A faces-type scale accompanies the response options and the symptom descriptions are simplified.
Proxy-SSPedi: Proxy-SSPedi is identical to SSPedi except that the leading question refers to "your child" rather than "you". It is designed for children 2-18 years of age.
Co-SSPediOther
Co-SSPedi: Co-SSPedi is based upon either SSPedi (age 8-18) or mini-SSPedi (age 4-7).
Co-SSPedi is meant to be completed by both child and parent together. The format and wording is identical to self-report SSPedi and mini-SSPedi (depending on child age) to maximize the ability of the child to participate in symptom reporting.
The approach uses written instruction that asks the dyad who will hold the device and enter the agreed-upon scores. The instruction then asks one member to read the leading question, each symptom and response options out loud. The child answers how bothered they are by that symptom out loud. The parent then states if they agree or they can offer a different answer. If the answer is different, the instruction asks the dyad to discuss until they agree upon an answer. The agreed-upon answer is then entered into co-SSPedi. This process is repeated for the remaining 14 symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Patient/Proxy-SSPedi Administered First | Other | Parent/child dyads will complete self-report SSPedi/mini-SSPedi and proxy-SSPedi as the first "period" and then co-SSPedi as a second "period". Receives: Other: Patient/Proxy-SSPedi; Other: Co-SSPedi |
| Co-SSPedi Administered First | Other | Parent/child dyads will complete co-SSPedi as the first "period" and then self-report SSPedi/mini-SSPedi and proxy-SSPedi as a second "period". Receives: Other: Patient/Proxy-SSPedi; Other: Co-SSPedi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Screening in Pediatrics Tool (SSPedi) total score
The total SSPedi score is a measure that reflects the total burden of bothersome symptoms experienced.
Total unweighted scores will be calculated for co-SSPedi, SSPedi/mini-SSPedi and proxy-SSPedi. The scoring for all instruments is identical. Each item's Likert score ranges from 0 (no bother) to 4 (worst bother); Likert scores are summed for a total score that ranges from 0 (none) to 60 (worst possible).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start19 Aug 2021
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Crossover
- Model description
- This is a randomized cross-over study that involves a single interview where the primary analysis will involve the first period only.
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lillian Sung, The Hospital for Sick Children
- Investigators
- Lillian Sung, MD, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012917
- Sponsor's protocol ID
- 1000076793
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dupuis LL, Johnston DL, Baggott C, Hyslop S, Tomlinson D, Gibson P, Orsey A, Dix D, Price V, Vanan M, Portwine C, Kuczynski S, Spiegler B, Tomlinson GA, Sung L. Validation of the Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Natl Cancer Inst. 2018 Jun 1;110(6):661-668. doi: 10.1093/jnci/djx250.
PubMed 29272441Hyslop S, Dupuis LL, Baggott C, Dix D, Gibson P, Kuczynski S, Johnston DL, Orsey A, Portwine C, Price V, Spiegler B, Tomlinson D, Vanan M, Tomlinson GA, Sung L. Validation of the Proxy Version of Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Pain Symptom Manage. 2018 Jul;56(1):107-112. doi: 10.1016/j.jpainsymman.2018.03.025. Epub 2018 Apr 6.
PubMed 29630923
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial a Dyad Approach to Symptom Screening (Co-SSPedi) vs. Proxy-report (Proxy-SSPedi) and Self-report (SSPedi or Mini-SSPedi) for Pediatric Patients Receiving Cancer Treatments
- ClinicalTrials.gov ID
- NCT05012917
- Acronym / sponsor ID
- 1000076793
- Conditions
- Pediatric Cancer, Quality of Life, Symptom Screening
- Keywords
- Pediatric Oncology, Randomized Controlled Trial, Symptom Screening, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 19 Aug 2021 (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.
Symptoms are common and often severely bothersome in pediatric patients receiving cancer treatments. In order to measure the extent of bothersome symptoms, the Symptom Screening in Pediatrics Tool (SSPedi) was developed. It is reliable, valid and responsive to change in pediatric patients aged 8-18 years receiving cancer treatments. Mini-SSPedi was developed for children 4-7 years and exhibits face and content validity. These instruments were developed to address the lack of appropriate symptom screening tools for this population. They are available in both self-report and proxy-report formats.
Differences between child self-report and parent proxy-report quality of life (QoL) scores have been well described in pediatric populations. There has been increasing recognition that each reporter may have unique and valid perspectives. This has led to a suggestion to collect both child and parent report when possible.
When used in clinical care, obtaining both child and parent report will commonly not be feasible. There are settings in which children will not be willing to independently report symptoms, such as when they are very ill. Unfortunately, it is particularly in this setting that obtaining symptoms reports is crucial. While young children may be able to independently report symptoms on a single occasion in the context of a carefully conducted research study, they are less likely to be able to repeatedly and independently report their symptoms. Finally, the burden and logistical complexity of separate child and parent reporting would be associated with considerable challenges for clinical implementation.
In considering how routine symptom screening could be implemented into clinical practice, we hypothesized that a dyad approach, where SSPedi is completed by both the child and parent together, may be one way to address these challenges. Consequently, we developed and finalized the approach to co-SSPedi administration, with instruction that is easy to understand, resulting in dyads completing co-SSPedi correctly.
To understand the relationships between the available forms of SSPedi (co-SSPedi, proxy-SSPedi and SSPedi), outstanding questions are how co-SSPedi scores compare to either proxy-report or self-report SSPedi and whether the co-SSPedi administration approach increases or decreases score variability. This study is designed to address these questions.
Detailed description
The overall goal of this randomized, cross-over study is to describe the distribution of co-SSPedi scores when compared to proxy-report and self-report SSPedi or mini-SSPedi scores. We hypothesize co-SSPedi would be significantly different than proxy-report and self-report SSPedi with respect to score distribution, and would have decreased symptom score variability.
Aim 1: To compare the mean co-SSPedi scores vs. proxy-SSPedi for pediatric patients with cancer or HSCT recipients who are 4-18 years of age.
Aim 2: To compare the mean co-SSPedi scores vs. self-report SSPedi/mini-SSPedi scores for pediatric patients with cancer or HSCT recipients who are 4-18 years of age.
Aim 3: To describe differences in interquartile range, standard deviation and range between co-SSPedi scores vs. proxy-report or self-report SSPedi/mini-SSPedi scores.
Aim 4: To obtain qualitative feedback about the experience of completing symptom screening together vs. separately from pediatric patients and their parents
Overall Strategy
This study is a randomized cross-over study that involves a single interview where the primary analysis will involve the first period only. This study will be conducted at a single center, The Hospital for Sick Children (SickKids) in Toronto. The study population will comprise participants across all oncology and HSCT sections within the Division of Haematology/Oncology.
Research Methods
Eligibility: This study will enroll child-parent dyads. We will include English-speaking dyads of a child and a guardian, where the child is between 4-18 years of age and has a diagnosis of cancer or is a hematopoietic stem cell transplant (HSCT) recipient. Exclusion criteria will be illness severity, cognitive disability or other impairment that precludes completion of co-SSPedi, SSPedi/mini-SSPedi or proxy SSPedi according to the primary healthcare team. Both inpatients and outpatients will be eligible.
Procedures: The instruments will be administered on an electronic platform. Each dyad will complete both co-SSPedi as one "period" and then self-report SSPedi/mini-SSPedi and proxy-SSPedi as a second "period". Both "periods" will occur during the same dyad encounter. The order of periods will be randomized, resulting in two groups based upon the approach used in the first period. The allocation sequence will be computer generated and will be concealed from all participants, healthcare providers and research team members. Consenting participants will be randomized 1:1 to co-SSPedi administration first vs. self-report/proxy-report first using permuted block sizes and stratified by relapse status (yes vs. no), age (4-7, 8-10, 11-14 and 15-18 years) and outpatient/ inpatient at time of interview as our previous data suggested that these factors were the most strongly associated with higher total SSPedi scores.
The dyad will complete the randomized approach first and then will proceed to the alternate approach. After the second period, qualitative feedback will be elicited using a semi-structured interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized cross-over study that involves a single interview where the primary analysis will involve the first period only.
| Arm | Type | Receives |
|---|---|---|
| Patient/Proxy-SSPedi Administered First | Other | Other: Patient/Proxy-SSPedi, Other: Co-SSPediParent/child dyads will complete self-report SSPedi/mini-SSPedi and proxy-SSPedi as the first "period" and then co-SSPedi as a second "period". |
| Co-SSPedi Administered First | Other | Other: Patient/Proxy-SSPedi, Other: Co-SSPediParent/child dyads will complete co-SSPedi as the first "period" and then self-report SSPedi/mini-SSPedi and proxy-SSPedi as a second "period". |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Child and guardian both understand English
- Child is 4 to 18 years of age
- Child has diagnosis of cancer or is a hematopoietic stem cell transplant (HSCT) recipient
- Child is inpatient or outpatient
Key exclusion criteria (3 listed)
- Participants who have illness severity,
- cognitive disability, or
- visual impairment that preclude utilization of co-SSPedi, SSPedi/mini-SSPedi or proxy SSPedi according to the primary healthcare team
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 |
|---|---|---|
| Patient/Proxy-SSPediSSPedi and Mini-SSPedi: SSPedi is a symptom assessment scale for children 8-18 years of age that includes 15 symptoms considered most important by children receiving cancer treatment or HSCT, their parents and healthcare professionals. Each symptom is rated on a 5-point Likert scale consisting of 0="not at all bothered", 1="a little", 2="medium", 3="a lot" and 4="extremely bothered". The recall period is yesterday or today. Mini-SSPedi was developed for children 4-7 years of age and is comprised of the same 15 symptoms. Mini-SSPedi has a recall period of today with a 3-point Likert scale consisting of 0="not at all bothered", 2="medium" and 4="extremely bothered'. So, the anchors and mid-point are identical to SSPedi. A faces-type scale accompanies the response options and the symptom descriptions are simplified. Proxy-SSPedi: Proxy-SSPedi is identical to SSPedi except that the leading question refers to "your child" rather than "you". It is designed for children 2-18 years of age. | Other | Co-SSPedi Administered First, Patient/Proxy-SSPedi Administered First |
| Co-SSPediCo-SSPedi: Co-SSPedi is based upon either SSPedi (age 8-18) or mini-SSPedi (age 4-7). Co-SSPedi is meant to be completed by both child and parent together. The format and wording is identical to self-report SSPedi and mini-SSPedi (depending on child age) to maximize the ability of the child to participate in symptom reporting. The approach uses written instruction that asks the dyad who will hold the device and enter the agreed-upon scores. The instruction then asks one member to read the leading question, each symptom and response options out loud. The child answers how bothered they are by that symptom out loud. The parent then states if they agree or they can offer a different answer. If the answer is different, the instruction asks the dyad to discuss until they agree upon an answer. The agreed-upon answer is then entered into co-SSPedi. This process is repeated for the remaining 14 symptoms. | Other | Co-SSPedi Administered First, Patient/Proxy-SSPedi Administered First |
Primary outcome
Symptom Screening in Pediatrics Tool (SSPedi) total score
Time frame: Immediately after the intervention
The total SSPedi score is a measure that reflects the total burden of bothersome symptoms experienced. Total unweighted scores will be calculated for co-SSPedi, SSPedi/mini-SSPedi and proxy-SSPedi. The scoring for all instruments is identical. Each item's Likert score ranges from 0 (no bother) to 4 (worst bother); Likert scores are summed for a total score that ranges from 0 (none) to 60 (worst possible).
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 26 Sep 2023.
- Background: PubMed 29272441Dupuis LL, Johnston DL, Baggott C, Hyslop S, Tomlinson D, Gibson P, Orsey A, Dix D, Price V, Vanan M, Portwine C, Kuczynski S, Spiegler B, Tomlinson GA, Sung L. Validation of the Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Natl Cancer Inst. 2018 Jun 1;110(6):661-668. doi: 10.1093/jnci/djx250.
- Background: PubMed 29630923Hyslop S, Dupuis LL, Baggott C, Dix D, Gibson P, Kuczynski S, Johnston DL, Orsey A, Portwine C, Price V, Spiegler B, Tomlinson D, Vanan M, Tomlinson GA, Sung L. Validation of the Proxy Version of Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Pain Symptom Manage. 2018 Jul;56(1):107-112. doi: 10.1016/j.jpainsymman.2018.03.025. Epub 2018 Apr 6.
- Individual participant dataSharing planned: No
Related trials for Pediatric Cancer
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
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.
Lillian Sung, MD, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient/Proxy-SSPedi and Co-SSPedi in people with Pediatric Cancer and Quality of Life, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Screening in Pediatrics Tool (SSPedi) total score (time frame: Immediately after the intervention). 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 NCT05012917, which also lists 2 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 26 Sep 2023.