Parent/Child Dyad Approach to Symptom Screening for Children With Cancer
Condition: Pediatric Cancer; Quality of Life; Symptom Screening
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Patient/Proxy-SSPedi; Co-SSPedi
Intervention type(s): Other; Other
Intervention description(s): 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: 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized cross-over study that involves a single interview where the primary analysis will involve the first period only.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatric Oncology; Randomized Controlled Trial; Symptom Screening; Quality of Life