Communication Training for Cancer Patients, Their Caregivers, and Their Doctors
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|ClinicalTrials.gov Identifier: NCT04479605|
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : July 26, 2021
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.
|Condition or disease|
|Communication and Illness Understanding|
|Study Type :||Observational|
|Estimated Enrollment :||32 participants|
|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|
|Actual Study Start Date :||July 15, 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
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 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).
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.
- 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.
- 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.
- Communicational self-efficacy [ Time Frame: 7 weeks ]will be measured with the 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) survey.
- Patient-caregiver communication quality [ Time Frame: 7 weeks ]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.
- Patient/caregiver-oncologist relationship strength [ Time Frame: 7 weeks ]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.
- Psychological distress [ Time Frame: 7 weeks ]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
- Meaning and purpose (patients, caregivers) [ Time Frame: 7 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479605
|Contact: Kelly Trevino, PhDfirstname.lastname@example.org|
|Contact: Andrew Epstein, MD||646-888-4313|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Kelly Trevino, PhD 646-888-0026 email@example.com|
|Contact: Andrew Epstein, MD 646-888-4313|
|Principal Investigator:||Kelly Trevino, PhD||Memorial Sloan Kettering Cancer Center|