Communication Intervention for Cancer Care

(PRECursOr Trial)

No longer recruiting at 1 trial location

Overseen By Ashley Sheets

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Cognitive impairment, Speech/hearing difficulties

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve communication during cancer care appointments by fostering more supportive conversations between doctors, patients, and caregivers. Researchers seek to evaluate this approach in real-life settings before introducing it to larger groups. The trial includes two groups: one using the new communication approach, called the Triadic Communication Intervention, and one without it. Women with advanced gynecologic cancer who are not in hospice care, along with their primary caregivers, may be eligible to join.

As an unphased trial, this study offers participants the chance to contribute to innovative communication strategies that could enhance cancer care experiences for many.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on communication during appointments, so it's unlikely that medication changes are required.

What prior data suggests that this communication intervention is safe?

Research shows that better communication between doctors, patients, and caregivers can enhance patient experiences. Studies have found that improved communication helps patients understand their treatment goals and receive better care.

This trial involves no physical treatments or medications. Instead, it focuses on improving communication during cancer care, eliminating risks related to medication side effects or adverse events. The goal is to make conversations more supportive and helpful. Therefore, joining this trial is very safe, as it only involves participating in discussions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Communication Intervention for Cancer Care because it focuses on enhancing the way patients, caregivers, and healthcare providers communicate. Unlike traditional cancer treatments that directly target the disease through medication or therapy, this intervention aims to improve the overall cancer care experience by fostering clearer, more effective communication. This technique could lead to better understanding of treatment plans, increased patient satisfaction, and potentially improved health outcomes by ensuring everyone involved is on the same page.

What evidence suggests that this communication intervention is effective for cancer care?

This trial will compare the effects of a communication intervention with a control group in cancer care. Research has shown that improving communication can greatly enhance interactions between patients, doctors, and caregivers. Participants in the intervention group triads will engage with strategies designed to improve communication. Studies have found these strategies help caregivers better understand the illness and use online health tools more effectively. Additionally, these strategies make important conversations, such as delivering difficult news, more effective. Overall, involving caregivers and encouraging open dialogue positively impacts the cancer care experience. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult women with advanced, incurable gynecologic cancers who are at a critical point in their illness and have not responded well to initial treatments. They must speak English and not be receiving palliative care or hospice. Caregivers primarily involved in the patient's care can also participate if they meet similar language criteria.

Inclusion Criteria

My current treatment isn't working, my illness is getting worse, or I was hospitalized due to symptoms in the last month.

I am a woman with advanced gynecologic cancer that has not improved with treatment.

You see a doctor who specializes in treating cancers of the female reproductive system at the IUSCCC gynecologic oncology clinic.

Exclusion Criteria

I do not have speech or hearing difficulties that would prevent me from participating.

I or my caregiver have cognitive difficulties.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a communication intention elicitation intervention prior to an outpatient oncology encounter

9 months

Regular outpatient oncology appointments

Follow-up

Participants are monitored for communication behavior changes and satisfaction through surveys and interviews

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Intervention group triads

Trial Overview

The study tests an intervention aimed at improving communication between healthcare providers, patients with gynecologic cancer, and their caregivers during outpatient appointments. It seeks feedback on this approach before expanding it to more people.

How Is the Trial Designed?

Group I: Intervention group triads Experimental Treatment 1 Intervention

Group II: Control group triads Active Control 1 Intervention

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

Effective medical communication is crucial for involving patients in their own care, yet many physicians lack the training to use it properly, which can hinder patient decision-making.

The analysis of a consultation in an oncology ward highlights common pitfalls in medical communication and offers practical suggestions for improving conversations between healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

["He does not know it yet"-Triadic communication and its pitfalls exemplified by an oncological ward round consultation]. Baldt, B.[2022]

In a study involving English-speaking adults with ovarian cancer, patient-centred communication (PCC) significantly improved health-related quality of life (HRQoL), with a total effect size of 9.47, indicating that effective communication is crucial for patient well-being.

Self-efficacy was found to mediate about 63.4% of the relationship between PCC and HRQoL, suggesting that enhancing patients' confidence in managing their health could be a key focus for interventions aimed at improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life, patient-centred communication and self-efficacy in ovarian cancer: a mediation analysis. Pozzar, RA., Xiong, N., Mazzola, E., et al.[2022]

Open, honest, and timely communication between clinicians and cancer patients is crucial, as it has been shown to reduce anxiety, especially when discussing life expectancy and prognosis.

While techniques that encourage patient participation in decision-making lead to greater satisfaction, they do not necessarily reduce distress, highlighting the need for personalized communication strategies that consider individual patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician-patient communication: a systematic review. Rodin, G., Mackay, JA., Zimmermann, C., et al.[2022]

Effective medical communication can be learned and significantly enhances treatment outcomes, particularly when it aligns with patients' communication preferences.

The COMSKIL program offers comprehensive training in medical communication for oncology professionals, covering essential skills through ten structured modules that address various challenging scenarios, such as delivering bad news and facilitating shared decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COMSKIL Communication Training in Oncology-Adaptation to German Cancer Care Settings. Hartung, TJ., Kissane, D., Mehnert, A.[2019]

The Oncotalk workshop, a 4-day residential program for 115 medical oncology fellows, significantly improved communication skills related to giving bad news and discussing transitions to palliative care, with participants acquiring an average of 5.4 and 4.4 new skills respectively (P<.001).

Post-workshop assessments showed substantial improvements, such as an increase from 16% to 54% in participants using the word 'cancer' when delivering bad news, indicating that the training effectively enhanced observable communication behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. Back, AL., Arnold, RM., Baile, WF., et al.[2022]

An advanced communication skills training program for oncology clinicians, consisting of nine modules, has been successfully implemented at a major cancer center, involving 515 participants since 2006.

The training significantly improved participants' self-efficacy in communicating with cancer patients, indicating that such programs can be both feasible and impactful in enhancing communication skills in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and implementing an advanced communication training program in oncology at a comprehensive cancer center. Bylund, CL., Brown, RF., Bialer, PA., et al.[2022]

In a review of 52 studies involving triadic communication between physicians, patients, and their companions, it was found that companions often play helpful roles during medical consultations, particularly in providing informational support.

However, the involvement of companions can also present challenges, as some behaviors may be perceived as dominating or demanding, highlighting the need for clear role preferences and strategies to optimize these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-patient-companion communication and decision-making: a systematic review of triadic medical consultations. Laidsaar-Powell, RC., Butow, PN., Bu, S., et al.[2022]

A systematic review of 62 phase III breast cancer chemotherapy trials revealed that 66% did not report details on prophylactic antiemetic treatments, indicating a significant gap in supportive care documentation.

The lack of reporting on supportive care interventions, such as growth factors and antibiotics, could negatively affect patient management and increase healthcare costs, highlighting the need for better guidelines in clinical trial reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials. Freedman, O., Amir, E., Zimmermann, C., et al.[2021]

Understanding family communication during a cancer diagnosis is crucial for improving patient outcomes, especially as survival rates increase and treatments become more complex.

Current research primarily focuses on couples and caregivers in breast cancer contexts, highlighting the need for broader studies on various cancers and family dynamics, along with recommendations for future research in familial life course, technology, and family structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family communication during the cancer experience. Harris, J., Bowen, DJ., Badr, H., et al.[2009]

Effective communication between patients and oncologists is crucial and can be improved through various strategies, including enhancing the patient-physician relationship and addressing patient emotions.

Despite the wealth of descriptive data on communication practices, there is a lack of intervention studies that directly connect improved communication to better patient outcomes in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-physician communication in oncology: what does the evidence show? Back, A.[2006]

Effective communication, both verbal and nonverbal, is crucial in breast oncology as it enhances patients' understanding of their disease and treatment options.

Improving communication in doctor-patient interactions leads to better patient compliance and satisfaction, which can positively influence psychological adjustment to breast cancer over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Communicating the results in breast oncology: nonverbal and verbal exchange]. Barreau, B., Tastet, S.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10875529/

Triadic communication with teenagers and young adults ...

Triadic communication refers to the presence of a third party, such as a parent, carer or companion in clinical encounters and the presence of ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/?otool=iaufhhslib&term=38367963

Triadic communication with teenagers and young adults ...

Triadic communication with teenagers and young adults with cancer: a systematic literature review - 'make me feel like I'm not the third person'.

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/pon.70108

Communication Interventions Targeting Both Patients and ...

Results indicate that combined communication interventions in oncology may improve patient-clinician communication outcomes in oncology settings ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0749208124001414

Patient Experiences of Patient–Clinician Communication ...

This research aimed to understand the experiences of patient-clinician communication during the critical moments of “breaking bad news” in cancer care.

5.

nature.com

nature.com/articles/s41523-021-00217-9

A randomized intervention involving family to improve ...

A brief, scalable communication intervention led to greater care partner MyChart use and increased illness understanding among patients with more engaged care ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10859277/

Healthcare provider assessments of caregiver ...

HCPs may perceive caregiver communication as helpful or challenging, and these triadic interactions may influence patient outcomes. Methods.

7.

oncnursingnews.com

oncnursingnews.com/view/patient-centered-communication-drives-supportive-care-needs-in-incurable-cancer

Patient-Centered Communication Drives Supportive Care ...

The Primary Palliative Care Communication Intervention (PRECURSOR) may improve the psychosocial experiences of patients with incurable gynecologic cancer and ...

8.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05580

Rapid Triadic Communication Intention Elicitation ...

When unaddressed, patients and caregivers experience adverse outcomes, including decreased quality of care, a lack of a shared understanding of treatment goals, ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8634534/

Multiple approaches to enhancing cancer communication ...

In this article, we examine the science of health communication focused on cancer and highlight important areas of research for the coming decade.