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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Communication and Illness Understanding

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Group/Cohort
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
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).
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Voice 2.0 consists of Oncologist training, patient and caregiver coaching, and caregiver support.
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 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, 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 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

Information from the National Library of Medicine

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


Contacts
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Contact: Kelly Trevino, PhD 646-888-0026 trevinok@mskcc.org
Contact: Andrew Epstein, MD 646-888-4313

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kelly Trevino, PhD    646-888-0026    trevinok@mskcc.org   
Contact: Andrew Epstein, MD    646-888-4313      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Kelly Trevino, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04479605    
Other Study ID Numbers: 20-241
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Caregiver Support Sessions
Patient & Caregiver Coaching
20-241