Clinical trial · Interventional
VOICE: Values and Options in Cancer Care
Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
NCT01485627CI-TRIAL-00036468VOICEcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Communication training and coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
- interventionNames
- Behavioral: Communication training and coaching
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients will receive usual care
Primary outcomes (1)
- measure
- Mean Patient-centered Communication in Advanced Cancer Score
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDMossman B, Perry LM, Voss HM, Maciejewski PK, Gramling R, Duberstein P, Prigerson HG, Epstein RM, Hoerger M. Patient-Caregiver Dyads & End-of-Life Care: Caregiver Personality Disrupts Gender-Based Norms. J Pain Symptom Manage. 2024 May;67(5):e393-e398. doi: 10.1016/j.jpainsymman.2024.01.030. Epub 2024 Jan 24. PMID 38278189
- DERIVEDEpstein RM, Duberstein PR, Fenton JJ, Fiscella K, Hoerger M, Tancredi DJ, Xing G, Gramling R, Mohile S, Franks P, Kaesberg P, Plumb S, Cipri CS, Street RL Jr, Shields CG, Back AL, Butow P, Walczak A, Tattersall M, Venuti A, Sullivan P, Robinson M, Hoh B, Lewis L, Kravitz RL. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):92-100. doi: 10.1001/jamaoncol.2016.4373. PMID 27612178
- DERIVEDHoerger M, Epstein RM, Winters PC, Fiscella K, Duberstein PR, Gramling R, Butow PN, Mohile SG, Kaesberg PR, Tang W, Plumb S, Walczak A, Back AL, Tancredi D, Venuti A, Cipri C, Escalera G, Ferro C, Gaudion D, Hoh B, Leatherwood B, Lewis L, Robinson M, Sullivan P, Kravitz RL. Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers. BMC Cancer. 2013 Apr 9;13:188. doi: 10.1186/1471-2407-13-188. PMID 23570278