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NCT Number: NCT03182998

Decision Aids to Improve Knowledge in Patients With Prostate Cancer

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Alaska Native Tribal Health Consortium, Anchorage, Alaska, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Internet-Based Intervention

Other

Receive "Knowing your Options" decision aid

Best Practice

Other

Undergo usual care

Other names: best practice, Best Practice, standard of care, standard therapy

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment, Quality-of-Life Assessment

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Knowledge Assessed by Prostate Cancer Treatment Questionnaire

    Time frame: 12 months

    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 proportion of total number correct. With 1.0 (12 out of 12 item average) being the best possible outcome and 0.0 (0 out of 12 item average) the worst possible outcome

Secondary outcomes

  1. Decisional Quality as Measured by Decisional Regret Scale

    Time frame: 12 months

    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 continuous scores were then grouped into two categories, 0 (no regret) and 1+ (at least some regret).

  2. Quality of Life Assessed by Questionnaire

    Time frame: 12 months

    The Expanded Prostate Cancer Index Composit (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 represented 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.

  3. Utilization as Determined by Chart Review

    Time frame: 12 months

    Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2017
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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