This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

VOICE: Values and Options in Cancer Care (VOICE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ronald Epstein, University of Rochester
ClinicalTrials.gov Identifier:
NCT01485627
First received: November 30, 2011
Last updated: April 30, 2017
Last verified: April 2017
November 30, 2011
April 30, 2017
April 2011
December 31, 2017   (Final data collection date for primary outcome measure)
  • Aim 1a Improved patient-physician-caregiver communication [ Time Frame: 3 years ]
    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 ]
    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.
Treatment Intent and Prognosis [ Time Frame: 2 years ]
Investigators will assess patient question-asking, assertive responses and expressions of concern.
Complete list of historical versions of study NCT01485627 on ClinicalTrials.gov Archive Site
  • Aim 1b&c Improved Patient-perceived communication [ Time Frame: 3 years ]
    Improved patient-perceived patient-physician-caregiver communication about prognosis and treatment choices, greater shared understanding (survey measures).
  • Aim 2 Patient and Caregiver well-being [ Time Frame: 3 years ]
    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 ]
    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 ]
    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).
Patient and Caregiver well-being [ Time Frame: 2 years ]
Investigators will assess patient and caregiver perceived happiness, well-being, and overall sense of peace.
Aim 3 Other caregiver outcomes [ Time Frame: 2 years ]
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).
Not Provided
 
VOICE: Values and Options in Cancer Care
Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Cancer
Behavioral: Communication training and coaching
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
  • Experimental: Intervention
    Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
    Intervention: Behavioral: Communication training and coaching
  • No Intervention: Control
    Patients will receive usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
470
December 31, 2017
December 31, 2017   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01485627
35388
R01CA140419-01A2 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Ronald Epstein, University of Rochester
University of Rochester
National Cancer Institute (NCI)
Principal Investigator: Ronald Epstein, MD University of Rochester
University of Rochester
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP