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

NCT05352451 | Completed DMC

• 2 other identifiers: 132114Pro2022000344
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Communication, Multidisciplinary

Keywords

oncology; communication

Outcome Measures

Primary Outcomes (2)

• Open-ended, Likert scale will measure fidelity

  Treatment fidelity will also be measured

  Two years

• Multiple-choice questions will measure fidelity

  Treatment fidelity will also be measured

  Two years

Secondary Outcomes (1)

• Coding a recording as a group

  2 years

Other Outcomes (7)

• 16-item Human Connection Scale measured by a four point Likert scale

  2 Years

• Cancer Care Assessment Survey-Trust

  Two years

• To measure a narrower construct, trust

  Two years

Study Arms (2)

Intervention Arm - coaching sessions

EXPERIMENTAL

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

Behavioral: Interventional Survey

Control Arm - interview

ACTIVE COMPARATOR

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.

Behavioral: Interventional Survey

Interventions

Interventional Survey BEHAVIORAL

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. The first interview, will ask about some basic information. In the second and last interview, will ask about experience of the coaching sessions and about how you feel about your decisions regarding your treatment and care. At each of the two time points, you and your caregiver will be interviewed separately. The video-conferencing, will be conducted through Zoom, which is a secure, widely used software which allows people to communicate remotely with computers, tablets, or smart phones. The software is available free of charge to you if you have a computer or other suitable device and internet.

Also known as: Questionnaire

Control Arm - interview; Intervention Arm - coaching sessions

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant of an oncologist participating in this study
• 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
• Fluent in English or Spanish and prefer speaking English or Spanish when talking about health care
• years or older;
• 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
• Able to communicate over the phone with the study team staff
• Willing to be audio-recorded for study-related communication

You may not qualify if:

• Test result on mental status do not meet the requirement for this study
• Receiving hospice care now

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute of New Jersey-University Hospital

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Communication; Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Biren Saraiya, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Aims to evaluate the feasibility of the methods and procedures required to mount a cluster-randomized study to improve prognostic understanding in persons with advanced cancer and their family caregivers. Building on the successful Values and Options in Cancer Care (VOICE) intervention conducted in Western NY and Northern CA from 2012-2018, we have made substantive changes to VOICE and developed VOICE 2. In this pilot cluster randomized trial, we will recruit 8 to 10 oncologists and approximately 32 to 40 patient-caregiver dyads in an effort to examine the acceptability and feasibility of study and intervention methods and procedures. The long-term goal of our research program is to improve patient and caregiver prognostic understanding, optimize healthcare utilization at the end-of-life (EOL), patient and caregiver quality of life at patient EOL, and caregiver bereavement adjustment.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 28, 2022
• Study Start: May 9, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)