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Prostate Cancer Stage INCT03522155

Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

A study testing Patient-centered communication of life expectancy in people with Prostate Cancer Stage I and Kidney Cancer Stage I, run by Cedars-Sinai Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Investigators will conduct a randomized trial to determine if providing patient-specific life expectancy estimates during treatment counseling via a targeted, patient-centered communication approach improves shared decision making and reduces rates of overtreatment of genitourinary malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patient-centered communication of life expectancy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteUnited States
Study dates
1 Sep 2021to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed clinical T1-2 prostate adenocarcinoma with Gleason scores of 7 or less
  • Newly diagnosed clinical T1a kidney cancer or renal masses < 4cm
  • Newly diagnosed clinical T2 nonmetastatic urothelial carcinoma of the bladder

Who cannot join

  • Under 18 years of age
  • Subjects with difficulty communicating or dementia
  • Non-English speakers

Trial locations and contacts

1 site in 1 country.

Timothy Daskivich, MD, MSHPM contact

(310) 423-4700 ext. 3-4700

timothy.daskivich@csmc.edu

United States1 site, 1 recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Timothy Daskivich, MD, MSPHM, 310-423-4700 ext. 3-4700, timothy.daskivich@cshs.org

    Recruiting

Other trials in United States

About this study

Official title: A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy

Investigators will conduct a randomized trial to determine if providing patient-specific life expectancy estimates during treatment counseling via a targeted, patient-centered communication approach improves shared decision making and reduces rates of overtreatment of genitourinary malignancies.

Read the detailed description

Subjects in the intervention arm will be provided with life expectancy estimates specific to their age and health status. Life expectancy estimates for prostate and kidney cancer patients will be estimated by age and Charlson comorbidity score cutoffs, and life expectancy for bladder cancer patients will be determined using definitions as noted by Cho et al. Talking points will be provided to counseling physicians on how to meaningfully communicate life expectancy data. Subjects will also complete a computer-based conjoint analysis exercise prior to the counseling visit; results will be used to help physicians understand how the subject values life expectancy compared with other decision attributes. The control arm will consist of the current standard of care for treatment counseling.

The intervention will be randomized at the level of the patient after stratification by type of cancer.

All participants will be asked to fill out a validated questionnaire to measure decisional conflict at the conclusion of their counseling visit. Investigators will audiotape treatment counseling visits to allow for qualitative analysis of the quality of communication of life expectancy information. Treatment choice will be documented to assess rates of aggressive versus non-aggressive treatment among patients with limited life expectancy.

Being tested
Patient-centered communication of life expectancy
Keywords
Conjoint Analysis, Life Expectancy, Patient-centered
Medical subject headings
Prostatic Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient-centered communication of life expectancyBehavioural

    The intervention arm will test if patient-specific LE estimates via a targeted, patient-centered communication approach paired with LE-specific conjoint analysis data improves decisional conflict, quality of LE discussion, and reduces rates of overtreatment of Genitourinary malignancies.

Study groups in NCT03522155
Study groupRoleWhat they receive
Intervention ArmExperimentalIntervention: (1) Subjects will be provided with patient-specific LE estimates, (2) counseling physicians will receive "talking points" to assist in meaningful communication of life expectancy, and (3) subjects will complete a computer-based conjoint analysis exercise prior to counseling.
Receives: Behavioral: Patient-centered communication of life expectancy
Standard-of-care ArmNo interventionPatients in the standard-of-care arm will not receive an intervention and will receive the usual standard of care for treatment counseling.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decisional Conflict

    Decisional conflict evaluated based on the total decisional conflict score (DCS). The scale measures the degree of certainty/uncertainty an individual feels in selecting choices, feelings of being uninformed or unclear about values, and feelings of satisfaction with the selected decision. Scores range from 0 to 100. A total score of 0 indicates no decisional conflict, while a score of 100 indicates extremely high levels of decisional conflict.

    Measured: At time of treatment decision, up to 12 weeks after diagnosis

Secondary outcomes (4)

  1. Treatment Choice

    The investigator will look at the difference in odds of aggressive vs. non-aggressive treatment. Aggressive treatment will be defined as surgery, radiation or ablative therapy; non-aggressive treatment will be defined as active surveillance, watchful waiting, or medical management.

    Measured: At time of treatment decision, up to 12 weeks after diagnosis

  2. Mention of life expectancy

    Difference in odds of mention of life expectancy (binary variable)

    Measured: At time of treatment decision, up to 12 weeks after diagnosis

  3. Time devoted to life expectancy

    Difference in proportion of time devoted to discussion of life expectancy (minutes discussed/total minutes)

    Measured: At time of treatment decision, up to 12 weeks after diagnosis

  4. Number of questions asked about life expectancy

    Difference in number of questions asked about life expectancy

    Measured: At time of treatment decision, up to 12 weeks after diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This randomized controlled trial will involve two arms: (1) an intervention arm consisting of a patient-centered communication strategy for life expectancy and (2) standard of care treatment counseling. The intervention will be randomized at the level of the patient to balance study arms in terms of measured and unmeasured patient characteristics.
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03522155
Sponsor's protocol ID
Pro00052777
Status last verified
Feb 2020
First submitted
18 Apr 2018
Last updated
6 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Investigators on this project will follow the NIH Grants Policy Statement concerning the sharing of research data and will make available to the public the results of the collaborative research and any accompanying data supported by this grant if funded. Such data shall be available in a timely fashion to researchers and/or the public upon request, provided that (1) such data may not be available until the time that it is used in connection with publication(s), (2) such data may be withheld for a reasonable amount of time to evaluate the impact of disclosure on patentability consistent with the Bayh-Dole Act, and (3) such data will not include any information that could be used to identify individual participants.

Publications

  • Daskivich TJ, Tan HJ, Litwin MS, Hu JC. Life Expectancy and Variation in Treatment for Early Stage Kidney Cancer. J Urol. 2016 Sep;196(3):672-7. doi: 10.1016/j.juro.2016.03.133. Epub 2016 Mar 21.

    PubMed 27012644

  • Daskivich TJ, Lai J, Dick AW, Setodji CM, Hanley JM, Litwin MS, Saigal C; Urologic Diseases in America Project. Variation in treatment associated with life expectancy in a population-based cohort of men with early-stage prostate cancer. Cancer. 2014 Dec 1;120(23):3642-50. doi: 10.1002/cncr.28926. Epub 2014 Jul 17.

    PubMed 25042117

  • Cho H, Klabunde CN, Yabroff KR, Wang Z, Meekins A, Lansdorp-Vogelaar I, Mariotto AB. Comorbidity-adjusted life expectancy: a new tool to inform recommendations for optimal screening strategies. Ann Intern Med. 2013 Nov 19;159(10):667-76. doi: 10.7326/0003-4819-159-10-201311190-00005.

    PubMed 24247672

  • Ryan M, Farrar S. Using conjoint analysis to elicit preferences for health care. BMJ. 2000 Jun 3;320(7248):1530-3. doi: 10.1136/bmj.320.7248.1530. No abstract available.

    PubMed 10834905

  • O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

    PubMed 7898294

Questions about this trial

What is this clinical trial studying?

A study testing Patient-centered communication of life expectancy in people with Prostate Cancer Stage I and Kidney Cancer Stage I, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Timothy Daskivich, MD, MSHPM ((310) 423-4700 ext. 3-4700, timothy.daskivich@csmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decisional Conflict (time frame: At time of treatment decision, up to 12 weeks after diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03522155, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.

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