Communication and Illness UnderstandingNCT04479605

Communication Training for Cancer Patients, Their Caregivers, and Their Doctors

An observational study of Communication and Illness Understanding, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to develop and test a new communication intervention, "Values and Options in Cancer Care 2.0" (VOICE 2.0), which involves oncologist training, patient and caregiver coaching, and caregiver support. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Communication and Illness Understanding
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2020to 14 May 2025
Phase: Observational
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Voice 2.0 consists of Oncologist training, patient and caregiver coaching, and caregiver support.

Who may be able to join

ONCOLOGISTS:
As per self-report, medical oncologist providing care to patients with gastrointestinal, genitourinary, gynecologic, lung, or hematologic cancers at MSK
As per self-report, not planning to leave MSK in the next six months
As per self-report, willing to be audio-recorded for Post-Training Follow-Up Interview
PATIENTS:
Per medical record and/or self-report, a patient of an oncologist participating in this study

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As per medical record and/or self-report, diagnosis of:
a hematologic cancer with disease progression following second-line treatment that is not eligible for transplant; OR
stage III or IV gastrointestinal, genitourinary, gynecologic, or lung cancer
As per medical record and/or self-report, fluent in English
As per medical record and/or self-report, age 18 or older
As per self-report, has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) who is willing and able to participate in the study
As per self-report, residency in New York or ability to complete sessions in New York to ensure that provision of intervention is covered by the professional licenses of interventionists (i.e., social workers licensed in New York State)
As per self-report, able to communicate over video-conference and phone for sessions
As per self-report, willing to be audio-recorded for assessments and study sess
CAREGIVERS:
As per patient report, is a primary informal caregiver ("a family member, partner, friend, or other individual involved with your health care issues, preferably someone who comes to physician appointments with you") for an MSK patient
As per self-report, fluent in English
As per self-report, age 18 or older
As per self-report, ability to complete sessions in a state the interventionists are legally allowed to practice in (i.e., social workers licensed in New York or New Jersey State; states with shared license laws)
As per self-report, able to communicate over video-conference and phone for sessions
As per self-report, willing to be audio-recorded for assessments and study sessions ** Language verification: For both patients and caregivers, prior to enrollment, all will be asked the following two questions by an CRC to verify English fluency necessary for participation in the study:
How well do you speak English? (must respond "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
What is your preferred language for healthcare? (must respond English)

Who cannot join

PATIENTS:
Score >4 on Short Portable Mental Status Questionnaire
As per self-report, feels too weak or cognitively impaired to participate in the intervention and complete the assessments
As per medical record or self-report, receiving hospice care at the time of enrollment
CAREGIVERS:
Score >4 on Short Portable Mental Status Questionnaire

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As per self-report, feels too weak or cognitively impaired to participate in the intervention and complete the assessments
As per medical record or self-report, receiving hospice care at the time of enrollment
As per patient or self-report, supports the patient in a professional role

Trial locations and contacts

1 site in 1 country.

United States1 site

Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Other trials in United States

About this study

Official title: Values and Options in Cancer Care 2.0 (VOICE 2.0): Building on Lessons Learned to Improve Communication and Illness Understanding in Cancer Patients and Their Caregivers

The VOICE 2.0 intervention was developed by members of the study team to improve communication among oncologists, patients with cancer, and caregivers. Researchers have found that clear communication about the patient's disease can help with the planning of that patient's future care and improve the well-being of both the patient and his or her caregiver. The long-term goals of developing and testing VOICE 2.0 include improving the care and respecting the wishes of cancer patients, and helping those patients and their caregivers have an improved quality of life during their experience with cancer.

Conditions: Communication and Illness Understanding
Keywords: Caregiver Support Sessions, Patient & Caregiver Coaching, 20-241
Medical subject headings: Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04479605
Study group	Role	What they receive
Patients with advanced cancer		Patient and caregiver coaching is facilitated by a booklet titled Our Cancer Care (Appendices E \& F) that includes a Question Prompt List (QPL) and resources for a Values Affirmation Exercise (Appendices G \& H). The QPL and Values Affirmation Exercises will be provided with a cover letter (Appendix I). The QPL consists of example questions to discuss with oncologists about diagnosis, prognosis, treatments, symptom management, transitions in care, self-care, family needs, and life goals. Patients and caregivers meet over video-conferencing with a study interventionist for one hour to review the QPL. The interventionist makes three follow-up phone calls to each dyad bi-weekly to evaluate use of the QPL.
Caregivers		Caregivers will participate in three 45-minute sessions with the interventionist over the telephone or video-conferencing (per caregiver preference) approximately bi-weekly. These sessions take place while the patient and caregiver are completing the three follow-up dyadic sessions. Efforts will be made to schedule the caregiver support sessions during weeks that fall between dyadic coaching sessions to minimize intervention burden on caregivers (i.e., avoiding scheduling two sessions for the caregiver in the same week).
Oncologists		The Oncologist training will be conducted online using Bridge, an internet-based platform designed to facilitate communication between instructors and learners. The training includes written information on and videos demonstrating target communication skills (Table 1) and knowledge acquisition checks. Five of the online modules are required and the remaining six modules are optional. The required modules are estimated to take oncologists approximately one hour to complete; the optional modules are estimated to take 90 minutes total (i.e., for all modules) to complete. Oncologists' logging history will be tracked in Bridge.

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility will be assessed by rates of accrual, retention, and intervention completion
Measured: 10 weeks
Intervention Acceptability
Intervention Acceptability will be assessed with Likert scale items with responses that range from 1 to 5 with higher scores indicating greater acceptability.
Measured: 7 weeks

Secondary outcomes (6)

Concordant illness understanding (oncologists, patients, caregivers)
will be measured using two items assessing participants' beliefs about the patient's chances of living two or more years and chances of being cured. Items are rated on a seven-point scale: 100%, 90% 75%, 50-50, 25%, 10%, 0%. Patient, caregiver, and oncologist responses that differ by two or more response categories will be categorized as discordant.
Measured: 7 weeks
Communicational self-efficacy
will be measured with the 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) survey.
Measured: 7 weeks
Patient-caregiver communication quality
will be assessed with the 5-item Family Communication subscale of the Cancer Communication Assessment Tool for Patients and Families, a valid measure in cancer patients and caregivers.
Measured: 7 weeks
Patient/caregiver-oncologist relationship strength
will be measured with the 16-item Human Connection scale Each item is rated on Likert scale from 1 to 4 with higher scores indicating a stronger relationship with the oncologist.
Measured: 7 weeks
Psychological distress
will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report measure45 commonly used with cancer patients46-51 and caregivers
Measured: 7 weeks
Meaning and purpose (patients, caregivers)
will be assessed with the 48-item Life Attitude Profile-Revised, a self-report measure of discovered meaning and the motivation to find purpose that has been used with advanced cancer patients and caregivers.
Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202014 May 2025

First posted21 Jul 2020
Study start15 Jul 2020
Primary completion14 May 2025
Study completion14 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Communication and Illness UnderstandingStudies of the same condition, open and under way.
More trials run by Memorial Sloan Kettering Cancer CenterThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04479605
Sponsor's protocol ID: 20-241
Status last verified: May 2025
First submitted: 16 Jul 2020
Last updated: 15 May 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Values and Options in Cancer Care 2.0 (VOICE 2.0): Building on Lessons Learned to Improve Communication and Illness Understanding in Cancer Patients and Their Caregivers
ClinicalTrials.gov ID: NCT04479605
Acronym / sponsor ID: 20-241
Conditions: Communication and Illness Understanding
Keywords: Caregiver Support Sessions, Patient & Caregiver Coaching, 20-241
Study type: Observational
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
Study start: 15 Jul 2020 (actual)
Primary completion: 14 May 2025 (actual)
Study completion: 14 May 2025 (actual)
First posted: 21 Jul 2020 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Patients with advanced cancer	–	–Patient and caregiver coaching is facilitated by a booklet titled Our Cancer Care (Appendices E \& F) that includes a Question Prompt List (QPL) and resources for a Values Affirmation Exercise (Appendices G \& H). The QPL and Values Affirmation Exercises will be provided with a cover letter (Appendix I). The QPL consists of example questions to discuss with oncologists about diagnosis, prognosis, treatments, symptom management, transitions in care, self-care, family needs, and life goals. Patients and caregivers meet over video-conferencing with a study interventionist for one hour to review the QPL. The interventionist makes three follow-up phone calls to each dyad bi-weekly to evaluate use of the QPL.
Caregivers	–	–Caregivers will participate in three 45-minute sessions with the interventionist over the telephone or video-conferencing (per caregiver preference) approximately bi-weekly. These sessions take place while the patient and caregiver are completing the three follow-up dyadic sessions. Efforts will be made to schedule the caregiver support sessions during weeks that fall between dyadic coaching sessions to minimize intervention burden on caregivers (i.e., avoiding scheduling two sessions for the caregiver in the same week).
Oncologists	–	–The Oncologist training will be conducted online using Bridge, an internet-based platform designed to facilitate communication between instructors and learners. The training includes written information on and videos demonstrating target communication skills (Table 1) and knowledge acquisition checks. Five of the online modules are required and the remaining six modules are optional. The required modules are estimated to take oncologists approximately one hour to complete; the optional modules are estimated to take 90 minutes total (i.e., for all modules) to complete. Oncologists' logging history will be tracked in Bridge.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Voice 2.0 consists of Oncologist training, patient and caregiver coaching, and caregiver support.

Key inclusion criteria (24 listed)

As per self-report, medical oncologist providing care to patients with gastrointestinal, genitourinary, gynecologic, lung, or hematologic cancers at MSK
As per self-report, not planning to leave MSK in the next six months
As per self-report, willing to be audio-recorded for Post-Training Follow-Up Interview
Per medical record and/or self-report, a patient of an oncologist participating in this study
As per medical record and/or self-report, diagnosis of:

Key exclusion criteria (9 listed)

Score >4 on Short Portable Mental Status Questionnaire
As per self-report, feels too weak or cognitively impaired to participate in the intervention and complete the assessments
As per medical record or self-report, receiving hospice care at the time of enrollment
Score >4 on Short Portable Mental Status Questionnaire
As per self-report, feels too weak or cognitively impaired to participate in the intervention and complete the assessments

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Feasibility will be assessed by rates of accrual, retention, and intervention completion
Time frame: 10 weeks
Intervention Acceptability
Time frame: 7 weeks
Intervention Acceptability will be assessed with Likert scale items with responses that range from 1 to 5 with higher scores indicating greater acceptability.

6 secondary outcomes

Concordant illness understanding (oncologists, patients, caregivers)
Time frame: 7 weeks
Communicational self-efficacy
Time frame: 7 weeks
Patient-caregiver communication quality
Time frame: 7 weeks
Patient/caregiver-oncologist relationship strength
Time frame: 7 weeks
Psychological distress
Time frame: 7 weeks
Meaning and purpose (patients, caregivers)
Time frame: 7 weeks

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 15 May 2025.
Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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.

Kelly Trevino, PhD principal investigator

Memorial Sloan Kettering Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Communication and Illness Understanding, run by Memorial Sloan Kettering Cancer Center 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 24 inclusion and 9 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 15 May 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?

Feasibility will be assessed by rates of accrual, retention, and intervention completion (time frame: 10 weeks). 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?

On the ClinicalTrials.gov record for NCT04479605.

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 15 May 2025.