Prognostic Communication for Cancer

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Not meeting inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance conversations about future expectations for young cancer patients and their families. It tests a new approach, the RIGHTimeCPV intervention, to facilitate discussions on how cancer might affect life and quality of life. The trial includes patients aged 12 to 25 with difficult-to-treat cancers and their caregivers. Doctors, nurses, and other support staff will also participate to evaluate the method's effectiveness in real-life settings. As an unphased trial, it provides a unique opportunity for patients to help improve communication strategies in cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the RIGHTimeCPV intervention is safe for pediatric oncology patients and caregivers?

Research has shown that the RIGHTimeCPV intervention offers a new way to discuss the future effects of cancer. This approach aims to enhance communication between patients, caregivers, and healthcare providers about expectations. As it is not a drug or medical treatment, traditional safety concerns like side effects do not apply. Instead, the focus is on the practicality and acceptability of this method for all involved.

Since this is not a medical treatment, there is no information about negative effects. The study aims to assess how well people manage and accept this new way of discussing cancer outcomes. The approach involves tailoring conversations to better fit the needs and preferences of patients and their families. The goal is to improve understanding and communication quality for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RIGHTimeCPV intervention because it focuses on improving communication between pediatric cancer patients, their caregivers, and healthcare providers. Unlike standard care, which often centers on medical treatment alone, this intervention aims to enhance the psychosocial aspect of care by addressing communication preferences and needs. By involving not just patients and their parents but also clinicians and oncologists, the intervention seeks to create a more holistic and supportive care environment. This could lead to better emotional outcomes and a more personalized care experience for young patients facing poor prognosis cancers.

What evidence suggests that the RIGHTimeCPV intervention is effective for prognostic communication in cancer?

Research has shown that clear and honest communication improves understanding between doctors, patients, and families. This principle underlies the RIGHTimeCPV program, which participants in this trial will experience. The program emphasizes sharing and respecting the communication preferences of patients and their caregivers. Studies indicate that when doctors understand and respect these preferences, conversations about the future improve, and trust builds among all involved. Early findings suggest that this approach clarifies the situation for everyone, easing difficult discussions about cancer for families. ^{1 3 4 6 7}

Who Is on the Research Team?

Erica C. Kaye, MD, MPH

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for pediatric oncology patients, their caregivers, and clinicians. It aims to gather feedback on a new method of discussing cancer prognosis. Participants must be involved in the care of young cancer patients.

Inclusion Criteria

Patients not anticipated by a pediatric oncologist to approach end of life in the next three months

Pediatric oncologists who treat eligible patients/caregivers at the study site, St. Jude Children's Research Hospital (SJCRH) or its included affiliates: Peoria, IL: The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic, Charlotte, NC: Novant Health Hemby Children's Hospital, Shreveport, LA: Ochsner LSU Health-Feist-Weiller Cancer Center

I am aged 12-25 with a cancer that has a low chance of survival.

Exclusion Criteria

Does not meet the stated inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the RIGHTimeCPV intervention, which includes identifying a communication preferences companion (CPC), reviewing intervention materials, and participating in a Communication Preferences Visit (CPV).

4-6 weeks

Multiple visits including CPV and disease re-evaluation visits

Follow-up

Participants are monitored for the impact of the intervention on communication quality and therapeutic alliance, with data collected at various timepoints including post-intervention interviews.

6 months

Post-intervention interviews and surveys

What Are the Treatments Tested in This Trial?

Interventions

• RIGHTimeCPV intervention

Trial Overview The study tests the RIGHTimeCPV intervention, which is a personalized approach to prognostic communication in pediatric oncology. It evaluates feasibility, acceptability among stakeholders, and its potential impact on communication quality.

How Is the Trial Designed?

Group I: RIGHTimeCPV intervention: Psychosocial/nursing clinicians Experimental Treatment 1 Intervention

Psychosocial/nursing clinicians who participate in the clinical care of participating patients/parents and serve as communication preferences companions (CPCs) under the auspices of this study

Group II: RIGHTimeCPV intervention: Pediatric oncologists Experimental Treatment 1 Intervention

Pediatric oncologists who treat participating patients/parents

Group III: RIGHTimeCPV intervention: Patients and Caregivers (parents) Experimental Treatment 1 Intervention

Pediatric patients aged 12-25 years with poor prognosis cancer who receive treatment at the study site or participating affiliate Caregivers of patients of any age who receive treatment at the study site (referred to as 'parent')

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. ctv.veeva.com ctv.veeva.com/study/revealing-information-genuinely-honestly-across-time-communication-preferences-visit

Revealing Information Genuinely & Honestly Across Time The RIGHTimeCPV intervention centers eliciting, sharing, and integrating individualized patient/parent preferences for prognostic communication ...

2. stjude.org stjude.org/care-treatment/treatment/childhood-cancer/brain-tumors-clinical-trials.html

Brain Tumor Clinical Trials | St. Jude Care & Treatment To study clear and honest communication to improve and support prognostic communication for cancer among physicians, patients, and families. Diagnosis ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004199/

Preferences for Communication About Prognosis Among ... This qualitative study uses interviews of patients with pediatric cancer and their parents and oncologists to examine preferred approaches to communication ...

4. policylab.us policylab.us/clinical-trials/l/conditions/cancer?page=7

Cancer Clinical Trials & Research Studies Near You (Updated 8/25) Secondary Objectives * To explore the potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding ...

5. stjude.org stjude.org/care-treatment/treatment/childhood-cancer/solid-tumor-clinical-trials.html

Solid Tumor Clinical Trials | St. Jude Care & Treatment To study clear and honest communication to improve and support prognostic communication for cancer among physicians, patients, and families. Diagnosis ...

6. ancora.ai ancora.ai/fr/details/NCT06993688

Revealing Information Genuinely & Honestly Across Time This study involves creating a personalized approach to discussing prognosis. Primary Objectives * To evaluate the feasibility of implementing the RIGHTimeCPV ...

7. reporter.nih.gov reporter.nih.gov/project-details/11159095

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