Clinical trial NCT04275102: Three Times Weekly Symptom Screening for Children With Cancer
Official title: A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Relapsed Cancer
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. SPARK is a web-based application that promotes symptom screening for children receiving cancer therapies and enables access to clinical practice guidelines for symptom management. Newly diagnosed and relapsed patients with cancer will be enrolled. Children and/or their guardian will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.

Detailed description: Primary objective is to determine the feasibility of three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks. Feasibility will be evaluated by compliance with symptom screening and the investigators anticipate that at least 75% can achieve compliance with at least 60% of symptom evaluations.

Newly diagnosed and relapsed patients with cancer 2-18 years of age will be enrolled Children will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.

Patient-reported outcomes will be obtained at baseline, and weeks 4, and 8. These outcomes will include the Symptom Screening in Pediatrics Tool (SSPedi), Fatigue will be measured using PROMIS, and the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. Data from health records will be abstracted for all enrolled participants to evaluate symptom documentation and intervention provision at times symptom screening is completed as well as emergency room visits, clinic visits and hospitalizations.

Analyses are descriptive. The investigators' primary outcome is feasibility, sample size justification will focus on having sufficient number of guardians and children to optimize study processes and to describe the number of completed symptom assessments. The investigators will enroll up to 20-30 children per site per cohort; it is anticipated the investigators can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for research purposes. If it is found that the processes are not feasible, the data will be reviewed after the initial cohort and enact refined procedures to rectify the identified problems. In this case enrollment of another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site.

Primary objective of feasibility of responsive respondent type will be to evaluate the feasibility of eliciting bothersome symptoms using co-SSPedi, mini-SSPedi, co-mini-SSPedi, SSPedi or proxy-SSPedi. We will include children with cancer who: (1) are 2-18 years of age at enrollment; (2) are English, French or Spanish speaking (SSPedi is validated in these languages); (3) have any cancer diagnosis regardless of relapse status (4) have received or have a plan to receive any chemotherapy, radiotherapy or surgery. Exclusion criteria will be cognitive disability or visual impairment (cannot see SPARK even with corrective lens).

The same procedures as above will be followed with the exception that 1) PRO outcomes will be PROMIS Fatigue, PROMIS Pain Interference, the Pediatric Nausea Assessment Tool and SSPedi; 2) A qualitative feedback interview will be administered at week 4 and week 8. 3) At each reminder to complete symptom screening, the participant can choose which type of SSPedi they wish to complete. We will track type of SSPedi used. Participants may be contacted in person, by email, text, or over the phone to ensure there are no technical barriers to completing SSPedi.

All statistics are descriptive. As our primary outcome is feasibility, sample size justification will focus on having sufficient number of children to optimize study processes and to describe the number of completed symptom assessments. We will enroll 20-30 children per site per cohort and anticipate we can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for our purposes. If we find that our processes are not feasible we will review the data after the initial cohort and enact refined procedures to rectify the identified problems. In this case we will enroll another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site.

The sample size calculation for the responsive respondent component will be the same as for the SSPedi feasibility study .

Eligibility criteria: Inclusion Criteria:

* cancer diagnosis
* 2-18 years of age at enrollment
* Child has received or a plan for any chemotherapy, radiotherapy or surgery
* Understands English, French or Spanish

Exclusion Criteria:

* Cognitive disability
* Visual impairment (cannot see SPARK even with corrective lens)

Primary outcomes:
measure: Feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks.
timeFrame: 8 weeks
Secondary outcomes:
measure: Symptom burden as measured by the total SSPedi score Total SSPedi symptom scores
timeFrame: Baseline and weeks 4, and 8
measure: QoL will be measured using the PedsQL 3.0 Acute Cancer Module
timeFrame: Baseline and weeks 4, and 8
measure: Symptom documentation
timeFrame: Baseline and weeks 4, and 8
measure: Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 8-week intervention
timeFrame: Baseline and weeks 4, and 8
measure: Fatigue
timeFrame: Baseline and weeks 4, and 8
measure: Nausea as measured by the Pediatric Nausea Assessment Tool
timeFrame: Baseline and weeks 4, and 8
measure: Pain as measured by PROMIS Pain Interference
timeFrame: Baseline and weeks 4, and 8
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Lillian Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: