Clinical trial NCT04479605: Communication Training for Cancer Patients, Their Caregivers, and Their Doctors
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Communication and Illness Understanding
Keywords: Caregiver Support Sessions
Patient & Caregiver Coaching
20-241
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Voice 2.0 consists of Oncologist training, patient and caregiver coaching, and caregiver support.

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.


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

Primary outcomes:
measure: Feasibility will be assessed by rates of accrual, retention, and intervention completion
timeFrame: 10 weeks
measure: Intervention Acceptability
timeFrame: 7 weeks
Secondary outcomes:
measure: Concordant illness understanding (oncologists, patients, caregivers)
timeFrame: 7 weeks
measure: Communicational self-efficacy
timeFrame: 7 weeks
measure: Patient-caregiver communication quality
timeFrame: 7 weeks
measure: Patient/caregiver-oncologist relationship strength
timeFrame: 7 weeks
measure: Psychological distress
timeFrame: 7 weeks
measure: Meaning and purpose (patients, caregivers)
timeFrame: 7 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kelly Trevino, PhD
role: PRINCIPAL_INVESTIGATOR
References: