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VOICE 2 Communication Intervention for Cancer Care

Phase 2
Recruiting
Led By Biren Saraiya, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
21 years or older
Received a diagnosis of hematologic cancer with disease progression following second-line treatment, OR a diagnosis of stage IV gastrointestinal, genitourinary, gynecologic, skin/soft tissue or thoracic/head and neck cancer
Must not have
Receiving hospice care now
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights

Summary

This trial is testing a new intervention called VOICE 2 to see if it is acceptable and feasible, and if it has any preliminary efficacy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a non-medical intervention focusing on surveys and communication strategies rather than drugs or medical procedures, traditional physical side effects are not applicable. Emotional discomfort due to sensitive topics discussed may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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My cancer has worsened after the second treatment or I have advanced cancer in specific areas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving hospice care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Multiple-choice questions will measure fidelity
Open-ended, Likert scale will measure fidelity
Secondary study objectives
Coding a recording as a group
Other study objectives
16-item Human Connection Scale measured by a four point Likert scale
8-item Modified Decision Regret scale39
Anxiety and Depression measured by a Patient Health Questionnaire Anxiety and Depression Scale using the PHQ-ADS scales.
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm - coaching sessionsExperimental Treatment1 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 - interviewActive Control1 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.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,342 Total Patients Enrolled
Biren Saraiya, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
91 Total Patients Enrolled

Media Library

Interventional Survey Clinical Trial Eligibility Overview. Trial Name: NCT05352451 — Phase 2
Multidisciplinary Communication Research Study Groups: Intervention Arm - coaching sessions, Control Arm - interview
Multidisciplinary Communication Clinical Trial 2023: Interventional Survey Highlights & Side Effects. Trial Name: NCT05352451 — Phase 2
Interventional Survey 2023 Treatment Timeline for Medical Study. Trial Name: NCT05352451 — Phase 2
~4 spots leftby Dec 2024
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