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

Active, not recruiting

• Conditions: Communication and Illness Understanding

• Registration Number: NCT04479605
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-15
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intervention Acceptability	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.
Feasibility will be assessed by rates of accrual, retention, and intervention completion	10 weeks

Secondary Outcome Measures

Name	Time	Method
Concordant illness understanding (oncologists, patients, caregivers)	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	7 weeks	will be measured with the 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) survey.
Patient-caregiver communication quality	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.
Psychological distress	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
Patient/caregiver-oncologist relationship strength	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.
Meaning and purpose (patients, caregivers)	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States