SPARK Symptom Screening and Feedback to Providers
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| ClinicalTrials.gov Identifier: NCT03593525 |
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Recruitment Status :
Recruiting
First Posted : July 20, 2018
Last Update Posted : August 17, 2021
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Sponsor:
The Hospital for Sick Children
Information provided by (Responsible Party):
Lillian Sung, The Hospital for Sick Children
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Brief Summary:
Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application which builds upon the Symptom Screening in Pediatrics Tool (SSPedi) and consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care clinical practice guideline (CPG) component. This proposal is a randomized controlled trial that compares daily completion of SSPedi via SPARK for 5 days with symptom feedback to healthcare providers compared with standard of care
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pediatric Oncology Quality of Life | Other: SPARK | Not Applicable |
Participants will be children with cancer or hematopoietic stem cell transplantation (HSCT) recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days. This will be a multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. The primary outcome will be the self-reported day 5 total SSPedi score (range 0-60; higher worse). Secondary outcomes will be the day 5 self-reported individual symptom, pain and QoL scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial. We will enroll 345 participants over 4 years from 7 Canadian centers
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 345 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Randomized Controlled Trial of Symptom Screening by Children With Cancer and Feedback to Providers |
| Actual Study Start Date : | September 1, 2018 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | July 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SPARK Intervention
Participants will complete symptom screening using SPARK once daily on a study-supplied iPad. For inpatients, daily reminders to complete SSPedi will appear on the iPad. Reports will be available to the child at any time. For outpatients, clinical research associates will provide the iPad in person daily and reports may be viewed at those encounters. The intervention is daily symptom screening with provision of reports to the healthcare team. Severe symptoms will result in email alerts. More specifically, SSPedi reports will be printed daily and provided in the patient chart. On days 1 and 3, an alert will be emailed to the physician providing direct medical care if any symptom is "a lot" or "extremely" bothersome (score 3 or 4 on 0-4 scale). Reports and alerts will have links to SPARK-housed CPGs.
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Other: SPARK
see above |
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No Intervention: Standard of Care Arm
Participants randomized to the control arm will not complete daily symptom screening. They will complete SSPedi on days 1 and 5 to obtain the primary outcome. Health care providers will not be notified of their SSPedi scores and no symptom reports or symptom alerts will be generated.
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Primary Outcome Measures :
- SSPedi (Symptom Screening in Pediatrics) Total Scores [ Time Frame: Measure will be completed by all participants on day 5±1 day. ]The primary outcome will be the self-reported total SSPedi score on day 5. The total SSPedi score is a validated measure that reflects the total burden of bothersome symptoms experienced. The total score is the sum of each of the 15 items' Likert scores which range from 0 (not at all bothered) to 4 (extremely bothered) to yield a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms).
Secondary Outcome Measures :
- Self-reported individual SSPedi (Symptom Screening in Pediatrics) symptom [ Time Frame: Measure will be completed by all participants on day 5±1 day ]Each of the 15 symptoms included in SSPedi will be secondary outcomes. (0 not bothered at all to 4 extremely bothersome)
- Faces Pain Scale-Revised [ Time Frame: Measure will be completed by all participants on day 5±1 day ]Self-reported pain will be assessed using the Faces Pain Scale-Revised which consists of a series of horizontal faces that depict a neutral facial expression of no pain on the left and worst pain on the right. It has 6 faces and may be scored on a 0 to 10 scale in which higher numbers denote more pain.
- PedsQL (pediatric Quality of Life) 3.0 Acute Cancer Module [ Time Frame: Measure will be completed by all participants on day 5±1 day ]Self-reported QoL will be measured using the PedsQL 3.0 Acute Cancer Module. This measure is a multidimensional instrument that is reliable and valid in children with cancer. It assesses pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance and communication. The self-report 7-day recall version will be used. The problems are rated from 0; never a problem to 4 if it is almost always a problem.Higher scores denote better health.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 8 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 8 to 18 years of age
- Diagnosis of cancer or have received or about to receive HSCT
- Understand English
- Expected to be in hospital or clinic for 5 day
Exclusion Criteria:
- illness severity
- cognitive disability
- visual impairment
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593525
Contacts
| Contact: Lillian Sung | 416-813-5287 | Lillian.sung@sickkids.ca |
Locations
| Canada, Ontario | |
| Lillian Sung | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Lillian Sung 4168135287 Lillian.sung@sickkids.ca | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Lillian Sung, MD | The Hospital for Sick Children |
| Responsible Party: | Lillian Sung, Pediatric Oncologist, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT03593525 |
| Other Study ID Numbers: |
REB: 000061139 |
| First Posted: | July 20, 2018 Key Record Dates |
| Last Update Posted: | August 17, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Lillian Sung, The Hospital for Sick Children:
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Pediatric Oncology Randomized Control Trial Symptom Screening Quality of Life |
Additional relevant MeSH terms:
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Neoplasms |