Skip to main content
OpenTrials
Completed

NCT Number: NCT04479605

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility will be assessed by rates of accrual, retention, and intervention completion

    Time frame: 10 weeks

  2. 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.

Secondary outcomes

  1. 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.

  2. Communicational self-efficacy

    Time frame: 7 weeks

    will be measured with the 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) survey.

  3. 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.

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2020
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.