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Symptom Screening Linked to Care Pathways for Children with Cancer: a Cluster Randomized Trial

Award Number: R01CA251112
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2020
PERIOD OF PERFORMANCE END DATE: 04/30/2025

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Symptom Screening Linked to Care Pathways for Children with Cancer: a Cluster Randomized Trial - PROJECT SUMMARY/ABSTRACT Impressive survival gains for children and adolescents with cancer have been, in part, attributable to the provision of intensive therapies. However, as a result, most children suffer and experience severe and distressing treatment-related symptoms. In adult cancer patients, routine collection of patient-reported outcomes (PROs) improves quality of life (QoL), and delivery of care consistent with clinical practice guidelines (CPGs) improves outcomes. However, little has been done in these areas for pediatric cancer patients. Thus, we developed SSPedi (Symptom Screening in Pediatrics Tool) and SPARK (Supportive care Prioritization, Assessment and Recommendations for Kids). SSPedi is a self-reported 15 item symptom screening tool for children receiving cancer treatment; it is reliable, valid and responsive to change in children 8-18 years. SPARK is a web-based application that consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care CPG component. Specific aims are among children with newly diagnosed cancer, to determine if three times weekly symptom feedback to healthcare providers using SPARK for 8 weeks and care pathways based on CPGs, when compared with usual care: (1) improves overall self- reported symptom scores (total SSPedi score); fatigue (PROMIS–Fatigue); and cancer-specific QoL (PedsQL 3.0 Acute Cancer Module); and (2) improves symptom documentation, provision of interventions for symptoms, and emergency department visits and unplanned clinic visits and hospitalizations. We propose a cluster randomized trial including 20 institutions. We will include children with cancer who are 8-18 years; speak English, Spanish or French; and have any newly diagnosed cancer with a plan for any treatment. For sites randomized to the intervention group (n=10), symptom screening using SPARK will be prompted three times weekly for 8 weeks with symptom reports provided to primary physicians and nurses (children may report symptoms more often if they wish). We will also adapt template care pathways based upon CPGs for symptom management for each intervention site. Control group (n=10) institutions will continue their usual care for symptom management. Conduct of routine symptom screening and availability of local CPGs and care pathways for symptom management will be recorded at all sites. For both groups, self- reported SSPedi (primary outcome), fatigue and QoL will be measured at baseline, week 4 (±1) and week 8 (±1). We will include 444 children at 20 institutions. The entire trial will require less than 5 years to complete. In order to improve symptom control in pediatric cancer, we need a feasible mechanism by which children with cancer can be enabled to report and track symptoms, for this information to be readily available to clinicians and to facilitate clinician adherence to supportive care CPGs for symptom management through creation of clinical care pathways. We anticipate the results to have a substantive impact on the care for pediatric cancer patients and on their QoL outcomes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $434,020 )
2024	2024	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON			CAN	Cancer Cause and Prevention Research	000	5	7/8/2024	NON-COMPETING CONTINUATION	$434,020
														Subtotal = $434,020

Issue Date FY: 2023 ( Subtotal = $440,242 )
2023	2023	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON			CAN	Cancer Cause and Prevention Research	000	4	5/12/2023	NON-COMPETING CONTINUATION	$440,242
														Subtotal = $440,242

Issue Date FY: 2022 ( Subtotal = $455,057 )
2022	2022	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON			CAN	Cancer Cause and Prevention Research	000	3	4/29/2022	NON-COMPETING CONTINUATION	$455,057
														Subtotal = $455,057

Issue Date FY: 2021 ( Subtotal = $468,460 )
2021	2021	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON			CAN	Cancer Cause and Prevention Research	000	2	4/10/2021	NON-COMPETING CONTINUATION	$468,460
														Subtotal = $468,460

Issue Date FY: 2020 ( Subtotal = $475,684 )
2020	2020	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Cancer Cause and Prevention Research	000	1	7/6/2020	NEW	$475,684
														Subtotal = $475,684

Grand Total All Awards = $2,273,463

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Symptom Screening Linked to Care Pathways for Children with Cancer: a Cluster Randomized Trial

Award Number: R01CA251112

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2020

PERIOD OF PERFORMANCE END DATE: 04/30/2025

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