VOICE: Values and Options in Care Care

This study is currently recruiting participants.
Verified September 2013 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01485627
First received: November 30, 2011
Last updated: September 1, 2013
Last verified: September 2013
  Purpose

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 Intervention
Cancer
Behavioral: Communication training and coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Aim 1a Improved patient-physician-caregiver communication [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Improved patient-physician-caregiver communication about prognosis and treatment choices (higher frequency of key pre-specified communication behaviors, coded from audio-recorded patient-caregiver-oncologist office visits).

  • Aim 1 Prolonged grief symptoms (Caregiver Bereavement) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Examine whether a health care communication intervention for oncologists, patients, and caregivers leads to better mental health outcomes in caregivers following patient death. Hypothesis: Compared with control, intervention group caregivers will have lower levels of prolonged grief symptoms on the PG-13 (Primary outcome), depression, anxiety, and thoughts of death 7 months after the patient's death.


Secondary Outcome Measures:
  • Aim 1b&c Improved Patient-perceived communication [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Improved patient-perceived patient-physician-caregiver communication about prognosis and treatment choices, fewer unmet needs for information and support, greater shared understanding (survey measures).

  • Aim 2 Patient and Caregiver well-being [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Greater patient and caregiver well-being, including quality of life and sense of peace (survey measures).

  • Aim 2 Caregiver Physical Health Outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Determine whether the intervention leads to better physical health outcomes in caregivers during bereavement following patient's death. Hypothesis: Intervention group caregivers will have better physical health summary scores on the SF-12 and lower levels of self-reported disability 7 months after the patient's death.

  • Aim 3 Health care utilization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Changes in health care utilization. Fewer aggressive interventions in the last week of life and more palliative care and hospice consultations following the intervention (chart audit).


Other Outcome Measures:
  • Aim 3 Other caregiver outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Examine whether caregiver outcomes are mediated by patient-reported quality of life and patient health care utilization (quantitative). Explore caregiver perspectives on decision-making and communication processes to link bereavement outcomes with VOICE study communication outcomes (qualitative).


Estimated Enrollment: 470
Study Start Date: April 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485627

Contacts
Contact: Sandy Plumb 585-506-9484 ext 208 sandy_plumb@urmc.rochester.edu
Contact: Ronald Epstein, MD 585-506-9484 ronald_epstein@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Sandy Plumb    585-506-9484 ext 208    sandy_plumb@urmc.rochester.edu   
Principal Investigator: Ronald Epstein, MD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Ronald Epstein, MD University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01485627     History of Changes
Other Study ID Numbers: 35388, 1R01CA140419-01A2
Study First Received: November 30, 2011
Last Updated: September 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Cancer
Communication
prognosis

ClinicalTrials.gov processed this record on April 17, 2014