Symptom Screening Linked to Care Pathways

NCT ID: NCT04614662

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 445 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2023-10-25

Brief Summary

Most children with cancer survive because they are given intensive treatments, but unfortunately, these treatments are associated with distressing symptoms. To address this problem, we developed the Symptom Screening in Pediatrics Tool (SSPedi) so that children receiving cancer treatments can communicate their bothersome symptoms, and Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK), a web-based application that links identified symptoms to supportive care guidelines for symptom management. To establish that these tools improve the lives of children newly diagnosed with cancer, we will conduct a trial that randomizes 20 pediatric cancer institutions and measures the impact of three times weekly symptom screening, symptom feedback to healthcare providers and the development of care pathways for symptom management to improve total symptom burden, fatigue and quality of life.

Detailed Description

Aims 1 and 2: Among children with newly diagnosed cancer, to determine if symptom screening and feedback to healthcare providers at least three times weekly and locally-adapted symptom management care pathways, when compared to usual care:

Aim 1. Improves overall self-reported symptom scores (total SSPedi score), fatigue (PROMIS-Fatigue) and cancer-specific QoL (PedsQL 3.0 Acute Cancer Module) over 8 weeks Hypothesis: Symptom screening and care pathways will improve symptoms, fatigue and QoL

Aim 2. Improves symptom documentation, increases provision of interventions for symptoms, and reduces emergency department visits and unplanned clinic visits and hospitalizations over 8 weeks Hypotheses: Symptom screening and care pathways will increase symptom documentation and provision of interventions for symptoms, and will reduce healthcare utilization.

Aim 3: As an exploratory aim, we will evaluate key elements of the intervention related to the external validity and generalizability of the intervention effects using the RE-AIM framework.

Overall Strategy This is a cluster randomized trial including 20 pediatric oncology sites. The coordinating center is The Hospital for Sick Children in Toronto, Canada. Sites will be randomized to either systematic symptom screening via SPARK with provision of symptom reports to healthcare providers containing links to care pathways for symptom management (intervention) or usual care (control).

Research Methods Eligibility: We will include children with cancer who: (1) are 8-18 years of age at enrollment (SSPedi is validated in this age range); (2) are English or Spanish-speaking (all PROs are validated in these languages in this age range); (3) have any newly diagnosed cancer; (4) have a plan for any chemotherapy, radiotherapy or surgery; and (5) enroll within 28 days after treatment initiation. Exclusion criteria will be cognitive disability (attending lower than second grade or equivalent) or visual impairment (cannot see SPARK even with corrective lens).

Procedures: In this cluster randomized trial, we will randomize sites to either intervention or control groups. At both intervention and control sites, we will enroll participants within 28 days after treatment initiation. Eligible participants will be identified by site personnel and the study will be explained to them by trained research team members. Participant capacity to consent will be assessed by the clinical or research team according to institutional standards. After the study has been explained and sufficient time has been provided to ensure all questions have been answered, informed consent and assent will be obtained from participants and guardians as appropriate. For those who decline to contribute PROs, they will be given the option to only participate in a retrospective chart review to evaluate symptom documentation, intervention provision and healthcare utilization. Careful tracking of all newly diagnosed patients by site research personnel will occur to determine how many patients are approached and consented, and where possible, reasons for declining participation.

For all enrolled participants who will be contributing PROs (excluding those only involved in the retrospective chart review), a personal SPARK account will be created to allow SSPedi to be completed and symptom results to be recorded. At the 10 intervention sites, site-specific symptom management care pathways will be adapted from template care pathways for each of the 15 symptoms included in SSPedi. Enrolled participants will be prompted by text or email to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers. Symptom reports will contain links to care pathways for symptom management. Active intervention will last for eight weeks starting from the date of enrollment. At the 10 control sites, participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways. Usual care will be provided to participants at control sites and thus, there will be no study-requested routine, systematic symptom screening, symptom feedback to providers, or linkage to care pathways. If sites already routinely perform systematic symptom screening or use care pathways for symptom management, these may be continued but their use will be recorded.

At both intervention and control sites, demographic information including age, sex, race, ethnicity, diagnosis, cancer stage, family socioeconomic information and treatment plan will be collected at enrollment. The following PROs will be obtained by trained research staff at baseline, week 4 and week 8 for all participants: SSPedi, PROMIS Fatigue and the PedsQL 3.0 Acute Cancer Module (Aim 1). We will contact participants ahead of time to coordinate the week 4 and 8 PROs so that they can be completed in person during hospitalizations or clinic visits. If unable to arrange completion of these PROs in person, we will use their contact information to complete the questionnaires by email, text or over the phone. Data from health records (Aim 2) will be abstracted for all enrolled participants. Relapse and cancer treatment received information will be collected at the end of the study.

Conditions

Pediatric Cancer; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.

Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.

Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.

Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.

Group Type: EXPERIMENTAL

SPARK Symptom Screening Linked to Feedback to Providers

Intervention Type: BEHAVIORAL

Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.

Control

At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SPARK Symptom Screening Linked to Feedback to Providers

Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 8-18 years of age at enrollment
• English or Spanish-speaking
• Any newly diagnosed cancer
• Have a plan for any chemotherapy, radiotherapy or surgery
• Enroll within 28 days after treatment initiation

Exclusion Criteria

• Cognitive disability (attending minimum second grade or equivalent)
• Visual impairment (cannot see SPARK even with corrective lens)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Lillian Sung

Pediatric Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lillian Sung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Laura Lee Dupuis, RPh, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Allison Grimes, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

The Leland Stanford Junior University

Redwood City, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Nemours Children's Hospital, Delaware

Wilmington, Delaware, United States

Nemours Children's Health, Jacksonville

Jacksonville, Florida, United States

Nemours Children's Hospital, Florida

Orlando, Florida, United States

Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, United States

Unity Point Health - Blank Children's Hospital

Des Moines, Iowa, United States

The University of Iowa

Iowa City, Iowa, United States

Children's Hospital

New Orleans, Louisiana, United States

Washington University School of Medicine

St Louis, Missouri, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

The Trustees of Columbia University in the City of New York

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 29272441 (View on PubMed)

Hinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.

Reference Type: BACKGROUND

PMID: 22829446 (View on PubMed)

Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.

Reference Type: BACKGROUND

PMID: 11932914 (View on PubMed)

Dupuis LL, Vettese E, Aftandilian C, Agarwal V, Baggott C, Bradfield SM, Crellin-Parsons N, Freyer DR, Kelly KM, King AA, Kyono W, Nagasubramanian R, Orgel E, Roth ME, Sherani F, Yu L, Grimes AC, Beauchemin MP, Klesges LM, Tomlinson GA, Sung L. Factors Associated With Self-Report Symptom Screening Adherence in Pediatric Cancer Patients. Cancer Med. 2025 Jul;14(14):e71053. doi: 10.1002/cam4.71053.

Reference Type: DERIVED

PMID: 40686265 (View on PubMed)

Dupuis LL, Vettese E, Grimes AC, Beauchemin MP, Klesges LM, Baggott C, Demedis J, Aftandilian C, Freyer DR, Crellin-Parsons N, Orgel E, Dickens D, Kelly KM, Kyono W, Walsh A, Sherani F, Cannone D, Orsey AD, King AA, Yu L, Woods-Swafford W, Bradfield SM, Roth ME, Esbenshade AJ, Caywood EH, Agarwal V, Nagasubramanian R, Tomlinson GA, Sung L. Symptom Screening Linked to Care Pathways for Pediatric Patients With Cancer: A Randomized Clinical Trial. JAMA. 2024 Dec 17;332(23):1981-1991. doi: 10.1001/jama.2024.19585.

Reference Type: DERIVED

PMID: 39535768 (View on PubMed)

Vettese E, Sherani F, King AA, Yu L, Aftandilian C, Baggott C, Agarwal V, Nagasubramanian R, Kelly KM, Freyer DR, Orgel E, Bradfield SM, Kyono W, Roth M, Klesges LM, Beauchemin M, Grimes A, Tomlinson G, Dupuis LL, Sung L. Symptom management care pathway adaptation process and specific adaptation decisions. BMC Cancer. 2023 Apr 17;23(1):350. doi: 10.1186/s12885-023-10835-0.

Reference Type: DERIVED

PMID: 37069510 (View on PubMed)

Dupuis LL, Grimes A, Vettese E, Klesges LM, Sung L. Readiness to Implement Symptom Management Care Pathways in Pediatric Cancer. Res Sq [Preprint]. 2020 Dec 30:rs.3.rs-136225. doi: 10.21203/rs.3.rs-136225/v1.

Reference Type: DERIVED

PMID: 33398260 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R01CA251112-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PJT-169165

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1000068699

Identifier Type: -

Identifier Source: org_study_id