Parent/Child Dyad Approach to Symptom Screening for Children With Cancer

NCT05012917 | Completed

• 1 other identifier: 1000076793
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pediatric Cancer; Quality of Life; Symptom Screening

Keywords

Pediatric Oncology; Randomized Controlled Trial; Symptom Screening; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately after the intervention

Study Arms (2)

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".

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".

Other: Patient/Proxy-SSPedi; Other: Co-SSPedi

Interventions

Patient/Proxy-SSPedi OTHER

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-SSPedi Administered First; Patient/Proxy-SSPedi Administered First

Co-SSPedi OTHER

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.

Co-SSPedi Administered First; Patient/Proxy-SSPedi Administered First

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (2)

• 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.

  PMID: 29272441 BACKGROUND

• Hyslop 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.

  PMID: 29630923 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lillian Sung, MD, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized cross-over study that involves a single interview where the primary analysis will involve the first period only.

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 19, 2021
• Study Start: August 19, 2021
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)