VOICE 2 Communication Intervention for Cancer Care

Overseen By Biren Saraiya, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Mental status, Hospice care

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a communication tool designed to improve understanding and communication among cancer patients, their caregivers, and oncologists. It includes coaching sessions and an interventional survey to assess the impact on emotional well-being and illness comprehension. Individuals with advanced stages of certain cancers, who have a caregiver able to participate, may be suitable candidates. Participants must communicate in English or Spanish about their healthcare and consent to having their sessions recorded. As an unphased trial, this study provides a unique opportunity to enhance communication skills and emotional well-being for both patients and caregivers.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that the VOICE 2 Communication Intervention is safe?

Research has shown that surveys and coaching sessions in these studies are generally safe and well-tolerated. Participants in previous studies reported improvements in physical activity, eating habits, stress, anxiety, depression, sleep, and overall quality of life, without major negative effects. One study found that health coaching sessions benefited cancer patients' physical and mental health. These activities focus on communication and self-management and do not involve physical procedures. No evidence suggests harmful side effects from these surveys or coaching sessions. Overall, past research indicates these treatments appear safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VOICE 2 Communication Intervention because it aims to enhance cancer care through improved communication. Unlike traditional medical treatments that focus solely on physical symptoms, this intervention uses coaching sessions to help patients and caregivers communicate more effectively about their needs and understand their illness better. By doing so, it has the potential to improve the overall cancer care experience and patient outcomes, offering a more holistic approach to treatment.

What evidence suggests that the VOICE 2 intervention could be effective for improving communication in cancer care?

Research shows that training in communication skills can greatly enhance how healthcare professionals interact with patients. In cancer care, studies have found that effective communication helps patients adhere to treatment plans and improves their emotional well-being. One study found that coaching enabled doctors to show empathy and encourage patient questions, making conversations more effective. These communication improvements can lead to better understanding and stronger relationships between patients, caregivers, and doctors. In this trial, participants in the intervention arm will attend coaching sessions, while those in the control arm will participate in interviews. Although direct data on VOICE 2 is limited, similar programs have demonstrated positive effects in medical settings. ^{6 7 8 9 10}

Who Is on the Research Team?

Biren Saraiya, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking adults over 21 with certain advanced cancers, who've had disease progression after second-line treatment. They must have a caregiver willing to join the study and be able to talk on the phone. Those in hospice care or failing mental status tests can't participate.

Inclusion Criteria

Participant of an oncologist participating in this study

Have a primary informal caregiver (as defined by an unpaid individual who provides you with emotional, physical, and/or practical support) who is willing and able to participate in the study

I can talk on the phone with the study team.

Exclusion Criteria

Test result on mental status do not meet the requirement for this study

I am currently receiving hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive coaching sessions and complete surveys

10 weeks

4 coaching sessions (in-person or virtual)

Control

Participants in the control group receive the 'Our Cancer Care' booklet and complete surveys

10 weeks

Follow-up

Participants are monitored for outcomes such as anxiety, depression, and therapeutic alliance

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Interventional Survey

Trial Overview VOICE 2 aims to improve communication between cancer patients, their caregivers, and oncologists. It's testing an interventional survey designed to enhance understanding of prognosis, strengthen relationships, and reduce anxiety/depression related to illness.

How Is the Trial Designed?

Group I: Intervention Arm - coaching sessions Experimental Treatment 1 Intervention

Intervention group, will be asked to complete the surveys before and after attending coaching sessions. The two interviews each lasting for about one hour and will be done in-person or through video-conferencing meeting (depending on which is more convenient for you) with a study team member

Group II: Control Arm - interview Active Control 1 Intervention

Will be asked to complete the same surveys at appropriate time after meeting with the research assistant. Be asked to complete brief questionnaire about the understanding of the illness. All individual interviews, patient and caregiver coaching, and caregiver support sessions will be audio recorded. The recorders are password protected and the audio files will be saved securely. Only authorized study team members can access the recordings to evaluate how well the answers to survey questions are logged and how well the coaching/support content is delivered by the study team member.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8147509/

Impact of a Novel Goals-of-Care Communication Skills ... Objective: To assess the impact of a communication training and coaching intervention (INT) for oncologists during GoC discussions. Design: We randomized ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419385060

Efficacy of communication skills training courses in oncology Good communication skills of health professionals have been found to increase treatment adherence, as well as psychological functioning of cancer patients [5].

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37036721/

Effect of a Coaching Intervention to Improve Cardiologist ... In this randomized clinical trial, a communication coaching intervention improved 2 key communication behaviors: expressing empathy and eliciting questions.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05352451

Values and Options in Cancer Care 2 (VOICE 2) A ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00421-2/fulltext

Effect of a prediction tool and communication skills training ... Effect of a prediction tool and communication skills training on communication of treatment outcomes: a multicenter stepped wedge clinical trial

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11903554/

Assessing the feasibility, acceptability, and preliminary ... Participant-reported outcomes collected via surveys included physical activity, eating habits, perceived stress, anxiety, depression, sleep, and quality of life ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12258200/

A Cross-Sectional Study on the Impact of Nurse-Led Health ... This study investigates the association between the frequency of health coaching sessions and key clinical and psychosocial outcomes among cancer patients.

8. journals.lww.com journals.lww.com/cancercareresearchonline/fulltext/2023/07000/development_and_evaluation_of_a_data_driven,.2.aspx

Development and Evaluation of a Data-driven, Interactive... A virtual interdisciplinary communication workshop designed to strengthen communication across ambulatory oncology team members.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1462388923001473

Effects of an interactive coaching intervention on quality ... Interventions supporting colorectal cancer survivors' self-management are critical for addressing the challenges they face after treatment and improving their ...

10. bmcmededuc.biomedcentral.com bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-05496-x

Study protocol of a randomized, controlled mixed-methods trial The quality of communication in oncology significantly impacts patients' health outcomes, as poor communication increases the risk of ...