Interventional Survey for Multidisciplinary Communication
Phase-Based Progress Estimates
Effectiveness
Safety
Rutgers Cancer Institute of New Jersey-University Hospital, New Brunswick, NJ
Multidisciplinary Communication
Interventional Survey - BehavioralEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 2 years
2 Years
16-item Human Connection Scale
16-item Human Connection Scale measured by a four point Likert scale
2 years
Coding a recording as a group
Two Years
Death anxiety, measured by a 15-item Death and Dying Distress Scale
Death anxiety, measured by a 15-item Death and Dying Distress Scale (DADDS)
Two year
Meaning and purpose measured by a 9-item Purpose in Life Scale
Meaning and purpose measured by a 9-item Purpose in Life Scale using a five-point Likert rating for each item
Two years
8-item Modified Decision Regret scale39
Anxiety and Depression measured by a Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Anxiety and Depression measured by a Patient Health Questionnaire Anxiety and Depression Scale using the PHQ-ADS scales.
Cancer Care Assessment Survey-Trust
Multiple-choice questions will measure fidelity
Open-ended, Likert scale will measure fidelity
To measure a narrower construct, trust
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Control Arm - interview
1 of 2
Intervention Arm - coaching sessions
1 of 2
Active Control
Experimental Treatment
40 Total Participants · 2 Treatment Groups
Primary Treatment: Interventional Survey · No Placebo Group · Phase 2
Intervention Arm - coaching sessions
Behavioral
Experimental Group · 1 Intervention: Interventional Survey · Intervention Types: BehavioralControl Arm - interview
Behavioral
ActiveComparator Group · 1 Intervention: Interventional Survey · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: Rutgers Cancer Institute of New Jersey-University Hospital · New Brunswick, NJ
N/AFirst Recorded Clinical Trial
1 TrialsResearching Multidisciplinary Communication
0 CompletedClinical Trials
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
361 Previous Clinical Trials
60,147 Total Patients Enrolled
Biren Saraiya, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
91 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have 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.
You 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.
You are able to communicate over the phone with the study team staff.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments