A Multisite, Parallel, RCT Comparing the Effectiveness of an Early Palliative Care Intervention, the PediQUEST Response to Pediatric Oncology Symptom Experience , Versus Usual Cancer Care in Children and Adolescents With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 6
- 主要终点
- Change in Child Quality of Life
研究概览
简要总结
PediQUEST Response proposes a new system of care that expects to improve quality of life in children, adolescents, and young adults with advanced cancer and their parents. The investigators want to learn whether patients that are cared for using PediQUEST Response do in fact feel better than those receiving usual care.
National recommendations call for early palliative care (PC) integration for seriously ill children to ease suffering, however, very few randomized controlled trials (RCTs) have evaluated whether PC improves child and family outcomes. In prior work, the investigators developed the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST/PQ), a software that collects electronic Patient-Reported Outcomes (e-PROMS) and generates feedback reports.
Now, the PI and research team developed PediQUEST Response (Response to Pediatric Oncology Symptom Experience). PediQUEST Response includes an enhanced PediQUEST system (web-based and with an App that allows to answer surveys and see reports), that is coupled with early integration of a palliative care consulting team (Response team). This dual strategy will help to standardize the family report of distress, which will be done through the PediQUEST system. It will also help standardize the providers' response to such distress, as providers will be specifically trained. Pilot work for PediQUEST Response found it feasible, well received by families and oncologists, and potentially effective.
Thus, the overall goal of this study is to conduct a RCT of PQ Response versus usual care at four large pediatric oncology centers among 136 children ≥2 years old with advanced cancer. Hypotheses include a) children receiving the intervention will have better (higher) quality of life scores b) parents of children in the intervention group will report better state-anxiety, depression and symptom-related stress scores, and c) intervention group families will demonstrate higher levels of activation.
详细描述
Background: Integration of palliative care (PC) has been associated with better health related quality of life (HRQoL) and longer survival in adults and their caregivers. Yet, only a few randomized controlled trials (RCTs) have evaluated whether PC integration improves child and family outcomes. The investigators propose to evaluate the effects of an early PC intervention (PediQUEST Response) for pediatric oncology patients (from here on called patients) with advanced cancer on patient and parent outcomes.
Aims:
- Aim 1 To evaluate whether PediQUEST Response, compared to usual care, improves patient's HRQoL (primary outcome) and symptom burden.
- Aim 2 To evaluate the impact of the intervention on parent psychological distress and symptom-related stress outcomes.
- Aim 3 To compare family activation by measuring coping strategies between study entry and 16 weeks, use of non-pharmacologic strategies for symptom treatment, and No. of documented psychosocial clinician encounters between intervention and control arms.
Design: Multisite, randomized (1:1), controlled, un-blinded, effectiveness trial comparing PediQUEST Response (intervention) vs usual cancer care (comparator).
Setting: Dana-Farber/Boston Children's Cancer and Blood Disorders Center (DFBCC), Seattle Children's Hospital, Children's Hospital of Philadelphia Cancer Center, and St. Jude's Research Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric oncology patients (children, adolescents, or young adults), and one of their parents, receiving routine cancer care at one of the participating centers -and not in remission and off cancer-directed treatment-that have:
- •(i) advanced cancer defined as: at least a 2-week history of progressive, recurrent, or non-responsive cancer of any type, or any brainstem tumor, or a grade IV Glioblastoma Multiforme, or decision not to pursue cancer-directed therapy in place, or or any other progressive/recurrent solid or brain tumor, and are
- •(ii) palliative care naive, defined as the palliative care team not currently integrated into their regular cancer care.
排除标准
- •The patient-parent dyad would be excluded if
- •patients are older than 18 years of age and no parent is involved in his/her care, or
- •if patient is under the care of foster parents who do not have legal guardianship, or
- •if both parents do not speak English or Spanish, or are unable to understand and complete surveys, or
- •if the patient has a non-brainstem low-grade glioma with localized progression/relapse only, or
- •is expected to receive a stem cell transplant within the next 18 weeks, or
- •life expectancy is less than two months.
研究组 & 干预措施
PediQUEST Response
- Weekly PediQUEST surveys are automatically assigned to parents and children (if 5 years old or older) and sent 48 hours prior to participant's usual clinic day
- Once a PediQUEST survey is assigned, automated email reminders/app notifications are sent daily for two days
- After 48 hours, unanswered or incomplete surveys are auto-submitted
- PQ-feedback report generated automatically after a PQ Survey is answered
- A pdf of the report is automatically emailed/available on mobile App to designated recipients
- Will also receive oncology-PC integrated care through the Response team
- Duration of follow-up: 18 weeks (2-week run-in period, followed by a 16-week post-randomization follow-up)
干预措施: PediQUEST Response (Other)
Usual Cancer Care
- Will receive the usual cancer care provided at the participating sites
- Will complete weekly PQ-Surveys (no feedback reports will be generated)
- Can receive regular palliative care consultations following the site's usual referral procedures
- Same follow-up (18 weeks)
干预措施: Usual Cancer Care (Other)
结局指标
主要结局
Change in Child Quality of Life
时间窗: Baseline and 16 weeks (measured monthly from point of randomization, the 16-week average was used).
The primary outcome was child Pediatric Quality of Life Inventory 4.0 (PedsQL) total score, analyzed by respondent: (a) parent-reported for all enrolled children (n=154), and (b) child-reported (if 5 years of age or older) (n=103). PedsQL total scores are calculated as the average of the 23 items that integrate the tool. Scores range from 0-100 (100 is excellent quality of life). A score of \<70 is considered fair/poor quality of life. Intervention effect was measured as the mean difference between arms of the difference between the 16-week average and baseline scores estimated using mixed linear models with child as a random effect. For unadjusted models we included study arm, time (categorical, 0 to 16 weeks) and arm-by-time interaction as fixed effects.
次要结局
- Change in Family Activation (Coping-instrumental Support)(Baseline and 16 weeks (measured at weeks 8 and 16 from point of randomization, the 16-week average was used).)
- Change in Child Quality of Life - Physical Subscale(Baseline (average of run-in scores, i.e. 2-3 scores) and 16 weeks (measured weekly from point of randomization, the 16-week average was used).)
- Change in Child Quality of Life - Psychosocial Subscale(Baseline (average of run-in scores, i.e. 2-3 scores) and 16 weeks (measured weekly from point of randomization, the 16-week average was used).)
- Change in Child Symptom Burden-PQMSAS Total(Baseline (average of run-in scores, i.e. 2-3 scores) and 16 weeks (measured weekly from point of randomization, the 16-week average was used).)
- Change in Child Symptom Burden- PQMSAS-physical Subscale(16 weeks (measured weekly from point of randomization))
- Change in Child Symptom Burden- PQMSAS-psychosocial Subscale(Baseline (average of run-in scores, i.e. 2-3 scores) and 16 weeks (measured weekly from point of randomization, the 16-week average was used).)
- Change in Parental Distress (Anxiety)(Baseline and 16 weeks (measured monthly from point of randomization, the 16-week average was used).)
- Change in Parental Distress (Depression)(Baseline and 16 weeks (measured monthly from point of randomization, the 16-week average was used).)
- Change in Family Activation (Symptom Treatment Activation - Number of Complementary Therapies (UCT) Used)(Baseline and 16 weeks (measured monthly from point of randomization, the 16-week average was used).)
- Change in Parental Distress (Stress)(Baseline and 16 weeks (measured at weeks 8 and 16 from point of randomization, the 16-week average was used).)
- Change in Family Activation (Symptom Treatment Activation - UCT - Types)(Baseline and 16 weeks (measured monthly from point of randomization, the 16-week average was used).)
- Change in Family Activation (Symptom Treatment Activation - Use of Psychosocial Services)(Data were collected from randomization point to 16 weeks point.)
研究者
Joanne Wolfe, MD, MPH
Principal Investigator
Massachusetts General Hospital