Titre officiel
A Randomized Controlled Trial a Dyad Approach to Symptom Screening (Co-SSPedi) vs. Proxy-report (Proxy-SSPedi) and Self-report (SSPedi or Mini-SSPedi) for Pediatric Patients Receiving Cancer Treatments
Sommaire:
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.
Description de l'essai
Primary Outcome:
- Symptom Screening in Pediatrics Tool (SSPedi) total score
The
overall goal of this randomized, cross-over study is to describe the
distribution of co-SSPedi scores when compared to proxy-report and
self-report SSPedi or mini-SSPedi scores. We hypothesize co-SSPedi would
be significantly different than proxy-report and self-report SSPedi
with respect to score distribution, and would have decreased symptom
score variability.
Aim 1: To compare the
mean co-SSPedi scores vs. proxy-SSPedi for pediatric patients with
cancer or HSCT recipients who are 4-18 years of age.
Aim 2: To compare the
mean co-SSPedi scores vs. self-report SSPedi/mini-SSPedi scores for
pediatric patients with cancer or HSCT recipients who are 4-18 years of
age.
Aim 3: To describe
differences in interquartile range, standard deviation and range between
co-SSPedi scores vs. proxy-report or self-report SSPedi/mini-SSPedi
scores.
Aim 4: To obtain
qualitative feedback about the experience of completing symptom
screening together vs. separately from pediatric patients and their
parents
Overall Strategy
This study is a
randomized cross-over study that involves a single interview where the
primary analysis will involve the first period only. This study will be
conducted at a single center, The Hospital for Sick Children (SickKids)
in Toronto. The study population will comprise participants across all
oncology and HSCT sections within the Division of Haematology/Oncology.
Research Methods
Eligibility: This study
will enroll child-parent dyads. We will include English-speaking dyads
of a child and a guardian, where the child is between 4-18 years of age
and has a diagnosis of cancer or is a hematopoietic stem cell transplant
(HSCT) recipient. Exclusion criteria will be illness severity,
cognitive disability or other impairment that precludes completion of
co-SSPedi, SSPedi/mini-SSPedi or proxy SSPedi according to the primary
healthcare team. Both inpatients and outpatients will be eligible.
Procedures: The
instruments will be administered on an electronic platform. Each dyad
will complete both co-SSPedi as one "period" and then self-report
SSPedi/mini-SSPedi and proxy-SSPedi as a second "period". Both "periods"
will occur during the same dyad encounter. The order of periods will be
randomized, resulting in two groups based upon the approach used in the
first period. The allocation sequence will be computer generated and
will be concealed from all participants, healthcare providers and
research team members. Consenting participants will be randomized 1:1 to
co-SSPedi administration first vs. self-report/proxy-report first using
permuted block sizes and stratified by relapse status (yes vs. no), age
(4-7, 8-10, 11-14 and 15-18 years) and outpatient/ inpatient at time of
interview as our previous data suggested that these factors were the
most strongly associated with higher total SSPedi scores.
The dyad will complete
the randomized approach first and then will proceed to the alternate
approach. After the second period, qualitative feedback will be elicited
using a semi-structured interview.
Voir cet essai sur ClinicalTrials.gov
