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ClinicalTrials.gov Identifier: NCT01485627
Recruitment Status : Completed
First Posted : December 5, 2011
Results First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ronald Epstein, University of Rochester

Brief Summary:
The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Communication training and coaching Not Applicable

Detailed Description:
The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
Actual Study Start Date : April 2011
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Intervention
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
Behavioral: Communication training and coaching
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.

No Intervention: Control
Patients will receive usual care



Primary Outcome Measures :
  1. Mean Patient-centered Communication in Advanced Cancer Score [ Time Frame: 3 years ]
    We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions. Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment. We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD. The 4-component z-scores were averaged to form the primary outcome. A higher Z score indicates better communication. The maximum possible Z-score ranged from -0.69 to 20.08.


Secondary Outcome Measures :
  1. Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13 [ Time Frame: 7 months ]
    The prolonged grief (PG-13) instrument was used to measure prolonged grief. The tool is a sum of ten items that measure separation distress, duration of grief, cognitive, emotional, and behavioral symptoms and impairment criterion. The range of the score is 10-50 with higher scores indicating more severe symptoms.

  2. Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians [ Time Frame: 3 years ]
    Patients and physicians were asked what the likelihood of survival in 2 years would be for the patient. They chose from 0, 10, 25, 50, 75, 90, 100% chance of survival in two years. A value of 0-6 was assigned to each pair of data. 0 indicating no difference in the reported value between patient and physician and 6 indicating the largest difference. For example if the physician said 100% and the patient said 0% the score was 6. The mean scores were reported by arm.

  3. Aim 2 Patient Well-being [ Time Frame: 3 years ]
    Original McGill quality of life and the FACT-G assessment tools were used. For the McGill tool scores range from 1 to 10 with higher scores indicating better outcome. For FACT-G scores range from 0 to 4. Higher score means a better outcome. Different parts of the McGill and FACT-G tools were used to create 5 standardized z scores: McGill QOL Scale single item, McGill Psychological Well-Being sub-scale, McGill Existential Well-Being sub-scale, FACT-G Physical Functioning sub-scale and FACT-G Social Functioning sub-scale. Sum of the five standardized z-scores is the Aggregate QOL score. A higher Z score indicates better outcomes. The maximum possible Z-score ranged from -3.54 to 1.24.

  4. Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment [ Time Frame: 7 months ]
    SF-12 scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

  5. Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life [ Time Frame: 3 years ]
    Patient charts were audited for 3 outcomes : 1) chemotherapy use, 2) aggressive treatments and 3) emergency department or hospital utilization. The total scores ranged from 0-6 with higher scores indicated worse outcomes. The sums of the means for the 3 outcomes were added to provide the total score.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Physicians

  • Currently in clinical practice at participating institutions
  • Oncologist that cares for patients with solid tumors
  • Not planning to leave the practice during the next 6 months

Inclusion Criteria: Patients

  • Currently a patient of an enrolled physician
  • Age 21 years or older
  • Diagnosis of advanced cancer
  • Able to understand spoken English (study personnel will read materials to low literacy patients)

Inclusion Criteria: Caregivers

  • Caregiver of a patient currently enrolled in the study
  • Age 21 years or older
  • Able to understand spoken English (study personnel will read materials to low literacy patients)

Exclusion Criteria: Physicians

  • Non Physicians and physicians who are not oncologists
  • Oncologists who exclusively care for patients with hematological malignancies
  • Prior involvement in health-related coaching interventions

Exclusion Criteria: Patients

  • Unable to complete orally-administered surveys in English
  • Hospitalized or in hospice care at the time of recruitment
  • Prior involvement in health-related coaching interventions
  • Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma

Exclusion Criteria: Caregiver

Unable to complete orally-administered surveys in English


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): NCT01485627


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ronald Epstein, MD University of Rochester
  Study Documents (Full-Text)

Documents provided by Ronald Epstein, University of Rochester:
Study Protocol  [PDF] February 20, 2016
Statistical Analysis Plan  [PDF] March 12, 2016


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ronald Epstein, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01485627     History of Changes
Other Study ID Numbers: 35388
R01CA140419-01A2 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2011    Key Record Dates
Results First Posted: January 10, 2019
Last Update Posted: January 10, 2019
Last Verified: January 2019

Keywords provided by Ronald Epstein, University of Rochester:
Cancer
Communication
prognosis