Communication, MultidisciplinaryNCT05352451
Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study
A study testing Interventional Survey in people with Communication, Multidisciplinary, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Communication, Multidisciplinary
- What is being tested?
- Interventional Survey
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 21 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
Who cannot join
- Test result on mental status do not meet the requirement for this study
- Receiving hospice care now
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey-University Hospital
New Brunswick, New Jersey, 08903
About this study
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.
Read the detailed description
The purpose of the research is to test whether the randomized recruitment of oncologist and their participants-caregivers dyads is feasible to improve communication and illness understanding in participants with advanced cancer and their caregivers. This study will be recruit oncologists first and randomize them to either control of intervention group. Participants and caregivers of the respective oncologists will be recruited and then assigned the same group.
The intervention group, a study team member will be meet with the caregiver for about one hour to review "Our Cancer Care" booklet and help the participant form questions that can be asked at the visit with the oncologist. This will be conducted in person or via secure video-conferencing program. There will be three follow up sessions where the study team member will ask the participants reflection of the prior conversation and the participants conversation with the oncologist and help formulate further questions or clarifications. These sessions should last about 20 minutes.
If assigned to the control group, the participant will receive "Our Cancer Care" booklet.
All participants participating in this study will, irrespective of the group assigned, will be asked to complete surveys about illness and the relationship with the oncology team at appropriate times during the study. A brief questionnaire about the understanding of the illness before and after receiving either the intervention or the booklet.
The time in the study is about one hour to complete each of the two set of surveys through an interview with the research staff, about five minutes to rate your illness understanding, and a total of about two hours for the four coaching sessions over a period lasting up to about ten weeks.
- Conditions
- Communication, Multidisciplinary
- Being tested
- Interventional Survey
- Keywords
- oncology, communication
- Medical subject headings
- Communication, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional SurveyBehavioural
Also called Questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Interventional Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open-ended, Likert scale will measure fidelity
Treatment fidelity will also be measured
Measured: Two years
Multiple-choice questions will measure fidelity
Treatment fidelity will also be measured
Measured: Two years
Secondary outcomes (1)
Coding a recording as a group
Trainees and trainers will then independently code two recordings and will meet to discuss coding differences
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start9 May 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication, MultidisciplinaryStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biren Saraiya, MD, Rutgers, The State University of New Jersey
- Investigators
- Biren Saraiya, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352451
- Sponsor's protocol ID
- 132114
- Other IDs
- Pro2022000344
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05352451
- Acronym / sponsor ID
- 132114
- Conditions
- Communication, Multidisciplinary
- Keywords
- oncology, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the research is to test whether the randomized recruitment of oncologist and their participants-caregivers dyads is feasible to improve communication and illness understanding in participants with advanced cancer and their caregivers. This study will be recruit oncologists first and randomize them to either control of intervention group. Participants and caregivers of the respective oncologists will be recruited and then assigned the same group.
The intervention group, a study team member will be meet with the caregiver for about one hour to review "Our Cancer Care" booklet and help the participant form questions that can be asked at the visit with the oncologist. This will be conducted in person or via secure video-conferencing program. There will be three follow up sessions where the study team member will ask the participants reflection of the prior conversation and the participants conversation with the oncologist and help formulate further questions or clarifications. These sessions should last about 20 minutes.
If assigned to the control group, the participant will receive "Our Cancer Care" booklet.
All participants participating in this study will, irrespective of the group assigned, will be asked to complete surveys about illness and the relationship with the oncology team at appropriate times during the study. A brief questionnaire about the understanding of the illness before and after receiving either the intervention or the booklet.
The time in the study is about one hour to complete each of the two set of surveys through an interview with the research staff, about five minutes to rate your illness understanding, and a total of about two hours for the four coaching sessions over a period lasting up to about ten weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - coaching sessions | Experimental | Behavioral: Interventional SurveyIntervention 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 |
| Control Arm - interview | Active comparator | Behavioral: Interventional SurveyWill 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 may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 21 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
Key exclusion criteria (2 listed)
- Test result on mental status do not meet the requirement for this study
- Receiving hospice care now
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional SurveyAlso: QuestionnaireComplete 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. | Behavioural | Control Arm - interview, Intervention Arm - coaching sessions |
Primary outcome
Open-ended, Likert scale will measure fidelity
Time frame: Two years
Treatment fidelity will also be measured
Multiple-choice questions will measure fidelity
Time frame: Two years
Treatment fidelity will also be measured
1 secondary outcome
Coding a recording as a group
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biren Saraiya, MD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional Survey in people with Communication, Multidisciplinary, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Open-ended, Likert scale will measure fidelity (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.