- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479605
Communication Training for Cancer Patients, Their Caregivers, and Their Doctors
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 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.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kelly Trevino, PhD
- Phone Number: 646-888-0026
- Email: trevinok@mskcc.org
Study Contact Backup
- Name: Andrew Epstein, MD
- Phone Number: 646-888-4313
Study Locations
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New York
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
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Contact:
- Kelly Trevino, PhD
- Phone Number: 646-888-0026
- Email: trevinok@mskcc.org
-
Contact:
- Andrew Epstein, MD
- Phone Number: 646-888-4313
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
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)
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility will be assessed by rates of accrual, retention, and intervention completion
Time Frame: 10 weeks
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10 weeks
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Intervention Acceptability
Time Frame: 7 weeks
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Intervention Acceptability will be assessed with Likert scale items with responses that range from 1 to 5 with higher scores indicating greater acceptability.
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7 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordant illness understanding (oncologists, patients, caregivers)
Time Frame: 7 weeks
|
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.
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7 weeks
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Communicational self-efficacy
Time Frame: 7 weeks
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will be measured with the 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) survey.
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7 weeks
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Patient-caregiver communication quality
Time Frame: 7 weeks
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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.
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7 weeks
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Patient/caregiver-oncologist relationship strength
Time Frame: 7 weeks
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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.
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7 weeks
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Psychological distress
Time Frame: 7 weeks
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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
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7 weeks
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Meaning and purpose (patients, caregivers)
Time Frame: 7 weeks
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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.
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7 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Kelly Trevino, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20-241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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