VOICE: Values and Options in Care Care

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 August 20, 2014