Clinical trial NCT05352451: Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study
Official title: Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication, Multidisciplinary
Keywords: oncology
communication
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aims to evaluate the feasibility of the methods and procedures required to mount a cluster-randomized study to improve prognostic understanding in persons with advanced cancer and their family caregivers. Building on the successful Values and Options in Cancer Care (VOICE) intervention conducted in Western NY and Northern CA from 2012-2018, we have made substantive changes to VOICE and developed VOICE 2. In this pilot cluster randomized trial, we will recruit 8 to 10 oncologists and approximately 32 to 40 patient-caregiver dyads in an effort to examine the acceptability and feasibility of study and intervention methods and procedures. The long-term goal of our research program is to improve patient and caregiver prognostic understanding, optimize healthcare utilization at the end-of-life (EOL), patient and caregiver quality of life at patient EOL, and caregiver bereavement adjustment.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The purpose of the research is to test whether the randomized recruitment of oncologist and their participants-caregivers dyads is feasible to improve communication and illness understanding in participants with advanced cancer and their caregivers. This study will be recruit oncologists first and randomize them to either control of intervention group. Participants and caregivers of the respective oncologists will be recruited and then assigned the same group.

The intervention group, a study team member will be meet with the caregiver for about one hour to review "Our Cancer Care" booklet and help the participant form questions that can be asked at the visit with the oncologist. This will be conducted in person or via secure video-conferencing program. There will be three follow up sessions where the study team member will ask the participants reflection of the prior conversation and the participants conversation with the oncologist and help formulate further questions or clarifications. These sessions should last about 20 minutes.

If assigned to the control group, the participant will receive "Our Cancer Care" booklet.

All participants participating in this study will, irrespective of the group assigned, will be asked to complete surveys about illness and the relationship with the oncology team at appropriate times during the study. A brief questionnaire about the understanding of the illness before and after receiving either the intervention or the booklet.

The time in the study is about one hour to complete each of the two set of surveys through an interview with the research staff, about five minutes to rate your illness understanding, and a total of about two hours for the four coaching sessions over a period lasting up to about ten weeks.

Eligibility criteria: 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

Primary outcomes:
measure: Open-ended, Likert scale will measure fidelity
timeFrame: Two years
measure: Multiple-choice questions will measure fidelity
timeFrame: Two years
Secondary outcomes:
measure: Coding a recording as a group
timeFrame: 2 years
Other outcomes:
measure: 16-item Human Connection Scale measured by a four point Likert scale
timeFrame: 2 Years
measure: Cancer Care Assessment Survey-Trust
timeFrame: Two years
measure: To measure a narrower construct, trust
timeFrame: Two years
measure: Anxiety and Depression measured by a Patient Health Questionnaire Anxiety and Depression Scale using the PHQ-ADS scales.
timeFrame: Two years
measure: Meaning and purpose measured by a 9-item Purpose in Life Scale using a five-point Likert rating for each item
timeFrame: Two year
measure: Death anxiety, measured by a 15-item Death and Dying Distress Scale (DADDS)
timeFrame: Two Years
measure: 8-item Modified Decision Regret scale39
timeFrame: Two years
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey-University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Biren Saraiya, MD
role: PRINCIPAL_INVESTIGATOR
References: