Clinical trial · Interventional
Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study
NCT05352451CI-TRIAL-00088326completedN/AClinicalTrials.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)
Primary Objective: Aim 1: To evaluate the acceptability and feasibility of recruitment strategies for subjects for VOICE 2 intervention. Secondary Objective: Aim 2: To test the preliminary efficacy of VOICE 2 on oncologist-patient, patient-caregiver, and oncologist-caregiver concordant prognostic understanding, oncologist-patient and oncologist-caregiver therapeutic alliance, patient/caregiver depression/anxiety and death anxiety, and patient/caregiver meaning/purpose.
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 |
|---|---|---|---|
| Communication, Multidisciplinary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interventional Survey | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm - coaching sessions
- description
- Intervention group, will be asked to complete the surveys before and after attending coaching sessions. The two interviews each lasting for about one hour and will be done in-person or through video-conferencing meeting (depending on which is more convenient for you) with a study team member
- interventionNames
- Behavioral: Interventional Survey
- type
- ACTIVE_COMPARATOR
- label
- Control Arm - interview
- description
- Will be asked to complete the same surveys at appropriate time after meeting with the research assistant. Be asked to complete brief questionnaire about the understanding of the illness. All individual interviews, patient and caregiver coaching, and caregiver support sessions will be audio recorded. The recorders are password protected and the audio files will be saved securely. Only authorized study team members can access the recordings to evaluate how well the answers to survey questions are logged and how well the coaching/support content is delivered by the study team member.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Participant of an oncologist participating in this study * Received a diagnosis of hematologic cancer with disease progression following second-line treatment, OR a diagnosis of stage IV gastrointestinal, genitourinary, gynecologic, skin/soft tissue or thoracic/head and neck cancer * Fluent in English or Spanish and prefer speaking English or Spanish when talking about health care * 21 years or older; * Have a primary informal caregiver (as defined by an unpaid individual who provides you with emotional, physical, and/or practical support) who is willing and able to participate in the study * Able to communicate over the phone with the study team staff * Willing to be audio-recorded for study-related communication Exclusion Criteria: * Test result on mental status do not meet the requirement for this study * Receiving hospice care now
References
Publications (0)
Data not yet available
No reference posted for this study.