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

NCT ID: NCT04479605

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2025-05-14

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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:

1. 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)

2. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Trevino, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

20-241

Identifier Type: -

Identifier Source: org_study_id