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

29 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary Objective: Aim 1: To evaluate the acceptability and feasibility of recruitment strategies for subjects for VOICE 2 intervention. Secondary Objective: Aim 2: To test the preliminary efficacy of VOICE 2 on oncologist-patient, patient-caregiver, and oncologist-caregiver concordant prognostic understanding, oncologist-patient and oncologist-caregiver therapeutic alliance, patient/caregiver depression/anxiety and death anxiety, and patient/caregiver meaning/purpose.

Research Team

Biren Saraiya, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+