Cost Talk: Discussing Cancer Care Costs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-12

Study Completion Date

2022-07-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate whether an encounter decision aid (used during a consultation) containing cost information about options, combined with clinician training about cost discussions and available financial resources, influence surgeon-patient cost conversations, referrals to address costs, patients' financial stress, and high-quality decision-making for patients with slow-growing prostate cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care

NCT03780491

Breast Cancer

COMPLETED NA

Feasibility and Utilization of an Application-based Question Prompt List

NCT03676920

Financial Toxicity Cancer Question Prompt List

COMPLETED NA

Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

NCT04314284

Gynecologic Cancer Colorectal Cancer Lung Cancer

COMPLETED NA

CARE Tool Study Aim 3

NCT07296887

Gynecologic Cancer Prostate Cancer Lung Cancer +1 more

NOT_YET_RECRUITING NA

Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

NCT06295367

Malignant Solid Neoplasm

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will use a stepped wedge design to evaluate the encounter decision aid. Each participating urologic surgeon will begin in the usual care arm of the study. Subsequently, the surgeons will be randomized to the intervention arm at staggered time points to undergo training and begin using the decision aid intervention with patients who are diagnosed with slow-growing prostate cancer. This study will consist of two aims. The first aim is to examine the use of an encounter decision aid with cost information on the presence and impact of out-of-pocket cost conversations. The investigators will train participating clinicians on how to use the decision aid intervention and available financial resources. With patient and clinician consent, the investigators will audio record clinical encounters and measure cost conversations using a previously-developed checklist to code transcripts derived from the audio recordings. Patients can still participate if they do not consent to audio recording as these topics will be assessed in the self-report survey after their clinic or virtual visit. The second aim will examine the impact of an encounter decision aid with cost information on high-quality decision-making. The investigators will collect a post-visit questionnaire from participating patients, including patient-reported measures of decisional conflict, decision regret, and the shared decision-making process. Participants will be sent a follow-up questionnaire 3 months after their initial study enrollment to assess decision regret and financial toxicity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a stepped wedge randomized trial. The intervention condition (the relevant Option Grid decision aid that includes cost information about option) is sequentially assigned to participating surgeons in 4 clusters. By the end of recruitment, all surgeons will have been exposed to the intervention (about 100 surgeon-patient encounters using the Option Grid) and will have provided data for the control (about 100 control cases). Independent eligible patients will be enrolled at each period within a cluster, thus, analyzed as a repeated cross-sectional study. Periods (steps) are set intervals of time. The length of each step is 3 months. Steps 1-3 provide data from both conditions within each cluster (step 0 provides data only from the control while step 4 provides data only from the Option Grid arm) and data is collected from all clusters. Each step will add one clinician to the Option Grid arm.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: Usual Care

* Each participating urologic surgeon will begin in the usual care arm of the study. Subsequently, they will be randomized to the intervention arm at staggered time points to undergo training and begin using the Option Grid decision aid intervention with patients who are diagnosed with slow-growing prostate cancer.
* Usual Care-Participating clinicians have treatment options discussion with patients with slow-growing prostate cancer. Visits are audio-recorded and/or described by patient self-report measure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2: Option Grid

* Each participating urologic surgeon will begin in the usual care arm of the study. Subsequently, they will be randomized to the intervention arm at staggered time points to undergo training and begin using the Option Grid decision aid intervention with patients who are diagnosed with slow-growing prostate cancer.
* Decision Aid-Participating surgeons use an encounter decision aid to discuss treatment options with patients who have slow-growing prostate cancer. Visits are audio-recorded and/or evaluated by patient self-report measure.

Group Type EXPERIMENTAL

Option Grid Decision Aid

Intervention Type BEHAVIORAL

-A table with side-by-side comparisons of treatment options organized as responses to patients' frequently asked questions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Option Grid Decision Aid

-A table with side-by-side comparisons of treatment options organized as responses to patients' frequently asked questions

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 18 years of age
* Visiting a participating urologist/urologic surgeon to discuss treatment options
* Slow growing prostate cancer defined as Gleason score of 6 or 7 (3+4) and/or PSA (prostate-specific antigen) level less than 10ng/ml or at surgeon's discretion
* Must be patients of one of the participating providers