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Stage II Prostate CancerPhase 3NCT03103321

Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

A Phase 3 study testing Internet-Based Intervention, Best Practice and Quality-of-Life Assessment in people with Stage II Prostate Cancer and Stage IIA Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Internet-Based Intervention, Best Practice and Quality-of-Life Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
28 sitesUnited States
Study dates
2 Oct 2017to 25 Nov 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
  • Prostate-specific antigen (PSA) < 50 ng/mL
  • Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
  • Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
  • Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
  • Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
  • Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures

Who cannot join

None listed.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Kaiser Permanente-Cadillac

    Los Angeles, California, 90034

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71103

  • Prisma Health Cancer Institute - Spartanburg

    Spartanburg, South Carolina, 29307

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • James J Peters VA Medical Center

    The Bronx, New York, 10468

Other trials in United States

About this study

Official title: Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To test the comparative effectiveness of decision aids (DA's) on patient knowledge.

SECONDARY OBJECTIVES:

  1. To test the impact of in-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.

II. To test the impact of out-of-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.

III. To test the impact of combined in-visit and out-of-visit DA's compared to both usual care and individual DAs on quality of life outcomes and treatment utilization.

IV. To test the comparative effectiveness of DA's on minority men's knowledge. V. To compare clinic time required to administer the DA's across arms.

OUTLINE: Patients are randomized into 1 of 4 arms.

ARM A: Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.

ARM B: Patients receive "Knowing your Options" decision aid before their consultation visit.

ARM C: Patients receive "Prostate Choice" decision aid during their consultation visit.

ARM D: Patients undergo usual care.

After completion of study, patients are followed up at 12 months.

Being tested
Internet-Based Intervention, Best Practice, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Internet-Based InterventionOther

    Receive "Knowing your Options" decision aid

  • Internet-Based InterventionOther

    Receive "Prostate Choice" decision aid

  • Best PracticeOther

    Also called standard of care, standard therapy

    Undergo usual care

  • Quality-of-Life AssessmentOther

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT03103321
Study groupRoleWhat they receive
Arm A ("Knowing your Options", "Prostate Choice")ExperimentalPatients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis
Arm B ("Knowing your Options")ExperimentalPatients receive "Knowing your Options" decision aid before their consultation visit.
Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis
Arm C ("Prostate Choice")ExperimentalPatients receive "Prostate Choice" decision aid during their consultation visit.
Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis
Arm D (usual care)Active comparatorPatients undergo usual care.
Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Knowledge Assessed by Prostate Cancer Treatment Questionnaire

    The primary outcome, knowledge, will be assessed by a standardized questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after the clinical consultation while the patient is still at the study site. The number correct from this 12-item measure will be reduced to a percentage of total number correct. With 100%(12 out of 12 item average) being the best possible outcome and 0%(0 out of 12 item average) the worst possible outcome

    Measured: 12 months

Secondary outcomes (4)

  1. Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret

    The Decisional Regret Scale is a short, 5-item scale measuring "distress or remorse after a (health care) decision." The instrument has been validated in other decision aid studies. Questions are answered on a 5-point agreement scale. A score of 0 means no decisional regret and 5 is the maximum level of regret. The median scores for each cohort were grouped into two categories, 0(no regret) and 1+(at least some regret).

    Measured: 12 months

  2. Clinical Time Required

    Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

    Measured: 12 months

  3. Quality of Life Assessed by Questionnaire

    The Expanded Prostate Cancer Index Composite(EPIC-26) measures health-related quality of life and returns summary scores for urinary, bowel, sexual, and hormonal domains with high test-retest reliability and internal consistency. Scores will be converted into continuous summary scores using standard algorithms. For the EPIC-26 questionnaire, scores were transformed into 0 to 100 scales, with a score of 0 representing the worst possible health-related quality of life and a score of 100 representing the most favorable health-related quality of life. The questionnaire will be administered once; 12 months after the patient's initial consultation.

    Measured: 12 months

  4. Utilization as Determined by Chart Review

    Will be categorized by the type of treatment the patient received. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

    Measured: 12 months

Timeline

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

  1. First posted6 Apr 2017
  2. Study start2 Oct 2017
  3. Primary completion5 Dec 2019
  4. Study completion25 Nov 2020

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 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03103321
Sponsor's protocol ID
A191402CD
Other IDs
NCI-2017-00482
Status last verified
Jan 2025
First submitted
31 Mar 2017
Last updated
27 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in the publication PubMed ID 34890060.

Publications

  • Tilburt JC, Zahrieh D, Pacyna JE, Petereit DG, Kaur JS, Rapkin BD, Grubb RL 3rd, Chang GJ, Morris MJ, Kovac EZ, Babaian KN, Sloan JA, Basch EM, Peil ES, Dueck AC, Novotny PJ, Paskett ED, Buckner JC, Joyce DD, Montori VM, Frosch DL, Volk RJ, Kim SP. Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD). Cancer. 2022 Mar 15;128(6):1242-1251. doi: 10.1002/cncr.34062. Epub 2021 Dec 10.

    PubMed 34890060

  • Pacyna JE, Kim S, Yost K, Sedlacek H, Petereit D, Kaur J, Rapkin B, Grubb R, Paskett E, Chang GJ, Sloan J, Basch E, Major B, Novotny P, Taylor J, Buckner J, Parsons JK, Morris M, Tilburt JC. The comparative effectiveness of decision aids in diverse populations with early stage prostate cancer: a study protocol for a cluster-randomized controlled trial in the NCI Community Oncology Research Program (NCORP), Alliance A191402CD. BMC Cancer. 2018 Aug 6;18(1):788. doi: 10.1186/s12885-018-4672-3.

    PubMed 30081846

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Internet-Based Intervention, Best Practice and Quality-of-Life Assessment in people with Stage II Prostate Cancer and Stage IIA Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 28 sites 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 7 inclusion and 0 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: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge Assessed by Prostate Cancer Treatment Questionnaire (time frame: 12 months). 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 NCT03103321, which also lists 2 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 27 Jan 2025.

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