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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Multiple-choice questions will measure fidelity

Open-ended, Likert scale will measure fidelity

Secondary outcome measures

Coding a recording as a group

Other outcome measures

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,192 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost limit for participants in this research endeavor?

"Affirmative. Evidence on clinicaltrials.gov affirms that recruitment for this study is still active, having been first posted on the 9th of May 2022 and last updated 21st July 2022. The trial calls for 40 patients to be enrolled at a single site."

Answered by AI

To what extent can Interventional Survey be deemed hazardous for participants?

"Our team marked Interventional Survey's safety as a 2 on our scale, due to previous data that supports the drug’s security but no clinical evidence of its efficacy."

Answered by AI

Are there still vacancies available for participants of this research?

"Affirmative. Information available on clinicaltrials.gov asserts that recruitment is currently underway for this medical trial, which was initially posted on May 9th 2022 and recently edited July 21st 2022. 40 participants are sought after from one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study

Biren Saraiya, MD 2022. "Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05352451.

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