Communication Intervention for Cancer Care

(PRECursOr Trial)

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

47 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to help test an idea designed to foster more supportive talk between providers (doctors or nurse practitioners), patients, and caregivers during an outpatient oncology appointment. A caregiver is the person the patient identifies is primarily involved in their healthcare. This study is collecting your reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.

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 data supports the idea that Communication Intervention for Cancer Care is an effective treatment?

The available research shows that effective communication in cancer care, such as the Communication Intervention for Cancer Care, improves patient understanding, satisfaction, and psychological adjustment. For example, one study highlights that meaningful communication helps patients better understand their disease and increases their satisfaction with care. Another study found that communication training for healthcare providers led to significant improvements in their confidence when talking to patients. These improvements suggest that the treatment is effective in enhancing the overall experience and outcomes for cancer patients. ^{1 2 3 4 5}

What safety data exists for the Communication Intervention for Cancer Care?

The provided research does not directly address safety data for the Communication Intervention for Cancer Care or its variants. The studies focus on the efficacy and implementation of communication skills training in oncology, highlighting improvements in communication behaviors, patient comprehension, and clinician self-efficacy. However, they do not provide specific safety data or evaluations of potential risks associated with these interventions. ^{1 4 6 7 8}

Is the treatment in the trial 'Communication Intervention for Cancer Care' a promising treatment?

Yes, the treatment is promising because effective communication in cancer care can improve patient understanding, satisfaction, and treatment outcomes. Training programs like COMSKIL show that communication skills can be taught and lead to better decision-making and emotional support for patients. ^{1 7 9 10 11}

Eligibility Criteria

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.

Read/speak English

Exclusion Criteria

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

I or my caregiver have cognitive difficulties.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Communicating the results in breast oncology: nonverbal and verbal exchange]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life, patient-centred communication and self-efficacy in ovarian cancer: a mediation analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Developing and implementing an advanced communication training program in oncology at a comprehensive cancer center. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Clinician-patient communication: a systematic review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. [2022]

7. Austria pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Family communication during the cancer experience. [2009]

10. Ireland pubmed.ncbi.nlm.nih.gov

Physician-patient-companion communication and decision-making: a systematic review of triadic medical consultations. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

COMSKIL Communication Training in Oncology-Adaptation to German Cancer Care Settings. [2019]