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Patient-caregiver Communication Intervention for Prognostic Understanding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833817
Recruitment Status : Completed
First Posted : February 7, 2019
Results First Posted : August 18, 2022
Last Update Posted : August 18, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The purpose of this study is to: (1) develop a communication-based intervention to improve advanced cancer patients' and caregivers' prognostic understanding using communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention among advanced cancer patients and their caregivers; and (3) test the preliminary efficacy of the intervention on patients' and caregivers' prognostic understanding (primary outcome); completion of DNR order, living will, and health care proxy; psychological distress; communication quality; caregiver burden; and healthcare utilization (secondary outcomes).

Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: Talking about Cancer (TAC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Communication-based Intervention for Advanced Cancer Patient-caregiver Dyads to Increase Engagement in Advance Care Planning and Reduce Caregiver Burden
Actual Study Start Date : September 20, 2020
Actual Primary Completion Date : June 17, 2021
Actual Study Completion Date : January 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Patient intervention arm
This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6).
Behavioral: Talking about Cancer (TAC)
The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.

Experimental: Caregiver (of patient) intervention arm
This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6).
Behavioral: Talking about Cancer (TAC)
The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.




Primary Outcome Measures :
  1. Change in Prognostic Understanding [ Time Frame: Baseline, post-intervention (within 30 days) ]
    Change in prognostic understanding is assessed at baseline and post-intervention with two items on prognostic understanding: (1) Terminal illness acknowledgement with the item "How would you describe your current health status?" Answer choices include: 1) Relatively healthy, 2) relatively healthy but terminally ill, 3) seriously ill but not terminally ill, and 4) seriously ill and terminally ill, and (5) I don't know]. Responses 2 and 4 are coded as accurate and responses 1, 3, and 5 are coded as inaccurate. (2) Life-expectancy [Months, Years, and "I don't know"]. Months are coded as accurate and years and I don't know are coded as inaccurate. Each variable is coded as 0=inaccurate or 1=accurate, for a total summary score range of 0 to 2. Differences between baseline and post-intervention assessments are calculated (possible range, -2 to +2) to determine changes in prognostic understanding.


Secondary Outcome Measures :
  1. Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention [ Time Frame: Baseline, post-intervention (within 30 days) ]
    Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

  2. Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up [ Time Frame: Baseline, follow-up (3 months) ]
    Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

  3. Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention [ Time Frame: Baseline, post-intervention (within 30 days) ]
    Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

  4. Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up [ Time Frame: Baseline, follow-up (3 months) ]
    Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

  5. Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to Post-Intervention [ Time Frame: Baseline, post-intervention (within 30 days) ]
    Change in caregiver engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to caregivers. Response options include: yes=1, no=0. Individual scores can range from 0 to 4, with higher scores indicating more decisions have been made. Change scores can range from -4 to +4.

  6. Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to 3-month Follow-up [ Time Frame: Baseline, follow-up (3 months) ]
    Change in caregiver engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to caregivers. Response options include: yes=1, no=0. Individual scores can range from 0 to 4, with higher scores indicating more decisions have been made. Change scores can range from -4 to +4.

  7. Change in the Number of Advance Directives Completed [ Time Frame: Baseline, post-intervention (within 30 days) ]
    Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.

  8. Change in Psychological Distress, as Measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, post-intervention (within 30 days) ]
    Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-intervention.

  9. Change in Communication Quality, as Measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) [ Time Frame: Baseline, post-intervention (within 30 days) ]
    Communication quality 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. Response options are on a 5-point Likert-type scale (1 = strongly disagree to 5= strongly agree). Scores can range from 5 to 25, with higher scores indicating worse communication quality. Change in communication quality will be assessed at baseline and post-intervention.

  10. Change in Caregiver Burden (Caregivers Only), as Measured by the Zarit Burden Interview [ Time Frame: Baseline, post-intervention (within 30 days) ]
    Caregiver burden will be assessed with the Zarit Burden Interview (ZBI), a reliable and valid 22-item measure of caregiver burden used in intervention studies of cancer caregivers. Response options are on a 5-point Likert-type scale (0 = never to 4=nearly always). Scores can range from 0 to 88, with higher scores indicating higher levels of burden. Change in caregiver burden will be assessed at baseline and post-intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient Inclusion Criteria:

  • Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy.
  • Ability to provide informed consent
  • Identification of an informal caregiver
  • Oncologist reported discussion of prognosis with the patient and/or caregiver.

Patient Exclusion Criteria:

  • Not fluent in English
  • Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6)
  • Too ill or weak to complete the interviews (as judged by the interviewer)
  • Currently receiving palliative care/hospice at the time of enrollment
  • Children and young adults under age 18
  • Deemed inappropriate for the study by their treating oncologist.
  • In addition, patient-caregiver dyads in which both members have an accurate understanding of prognosis (terminal status and life-expectancy) will be excluded due to the lack of need for an intervention.

Caregiver inclusion criteria:

  • The person (family member or friend) whom the patient indicates provides their informal (unpaid) care
  • English speaking
  • Able to provide informed consent

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): NCT03833817


Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Megan J Shen, PhD Fred Hutchinson Cancer Center
  Study Documents (Full-Text)

Documents provided by Weill Medical College of Cornell University:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03833817    
Other Study ID Numbers: 1803019107
R21CA224874 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2019    Key Record Dates
Results First Posted: August 18, 2022
Last Update Posted: August 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Weill Medical College of Cornell University:
advance care planning
prognostic understanding
communication
Additional relevant MeSH terms:
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Neoplasms