N/A
Completed N=485
VOICE: Values and Options in Cancer Care
Source: ClinicalTrials.gov NCT01485627 ↗Enrolled (actual)
485
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Mean Patient-centered Communication in Advanced Cancer Score — 0.16; -0.01 standardized score on a scale — p=0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Patient-centered Communication in Advanced Cancer Score |
0.16; -0.01 | 0.05 |
| SECONDARY Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13 |
19.3; 20.6 | 0.214 |
| SECONDARY Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians |
2.2; 2.5 | 0.05 |
| SECONDARY Aim 2 Patient Well-being |
-0.01; -0.07 | — |
| SECONDARY Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment |
48.9; 47.9 | 0.677 |
| SECONDARY Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life |
0.76; 0.58 | 0.19 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01485627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.