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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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met