Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials
ConditionQuality of Life Outcomes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age0-25
SponsorPhoenix Children's Hospital
About this trial
Although cure rates continue to rise, one in five children with cancer still die from their disease, so new therapies are urgently needed. Most advances in childhood cancer treatments have originated through clinical trial research and new therapies must be tested in early phase clinical trials. Phase 1 clinical trials are designed to focus mainly on determining whether a drug is safe, and less on how well it cures a disease. These trials may offer patients and families hope when no other options are available to treat their cancer. However, patients in these trials may also experience treatment-related side effects and earlier death. Patients and families enrolled in phase 1 clinical trials often experience increased levels of distress. This distress may result from physical effects of the disease or treatments, or from worry, sadness, or confusion when making difficult decisions related to care or end-of-life.
Pediatric palliative care (PPC) is a field that aims to ease physical, psychological, emotional, and spiritual suffering and may be beneficial to patients and families enrolling in phase 1 clinical trials. Over the past decade, PPC has been shown to improve quality of life, patient and family healthcare understanding and satisfaction, communication, shared-medical decision making, advanced care planning, and healthcare cost savings. Despite evidence showing the benefits of PPC, it is not used consistently in pediatric oncology care, particularly in the setting of early phase clinical trials. Including PPC experts is a proven way to improve access to specialty care for vulnerable populations. In this application, investigators propose a study to test the feasibility, acceptability, and potential impact of including PPC consultation for pediatric cancer patients and their families during their enrollment in phase 1 clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients (aged 0-25 years) diagnosed with cancer and undergoing evaluation for enrollment in a phase 1 trial, their caregivers, as well as their primary treating oncologist are eligible for study participation.
Disqualifiers
Previous palliative care exposure
Trial design
Design model
Single group
Treatments tested in this trial
Pediatric Palliative Care Consultation
BehavioralFormal PPC consultation will be completed by a subspeciality-trained PPC physician at each participating site for all study participants during the eligibility screening period for the phase 1 trial. Subsequent standard of care PPC follow-up visits will occur every 2-4 weeks to allow for variations in phase 1 trial structure.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Pediatric Palliative Care ConsultationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility
Feasibility will be defined as a mean FIM score of ≥ 3 (coded 1-5) for \> 50% of caregivers and oncology providers; enrollment: ≥ 70% of eligible patients/caregivers will assent/consent; adherence: ≥ 75% of enrolled participants will complete all PPC study assessments as planned. Themes identified from qualitative findings, specifically from caregivers/patients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.
Time frame
2 years2
Acceptability
Acceptability will be defined as a mean AIM score of ≥ 3 (coded 1-5) for \> 70% of caregivers and oncology providers. Themes identified from qualitative findings, specifically from caregivers/patients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.
Time frame
two yearsSecondary outcomes
1
Barriers and Facilitators to Palliative Care Integration
To assess participants' perceptions of how PPC integration at the time of phase 1 trial enrollment impacted quality of life and facilitators/barriers to PPC consultation, investigators will conduct a one-time, semi-structured interview with the caregiver/patient (\> 12 years) within 1 week following the third PPC visit or phase 1 study completion.
Time frame
two years2
Impact on quality of life
Investigators will administer the PROMIS-Pediatric Profile-25 survey (Patient-Reported Outcomes Measurement Information System) at baseline and within 1 week following the third PPC visit or phase 1 study completion. Patients' reported outcomes in the context of the PPC intervention will be assessed, including mobility, anxiety, depression, fatigue, peer relationships, and pain interference/intensity. This tool was validated for adolescents aged ≥ 8 years, translated into several languages for non-English-speaking participants, and requires 5-10 minutes for completion. PROMIS results are always reported on a T-score metric, which compares participants' results to a reference population (usually the U.S. general population). The greater the score, the more severe the symptoms (i.e. Less than 55: Normal or better-than-average; 55 - 60: Mild symptoms; 60 - 70: Moderate symptoms; Greater than 70: Severe symptoms).
Time frame
two yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Phoenix Children's Hospital
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov