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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04601272
Other study ID # 2005P002282
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 29, 2020
Est. completion date June 24, 2021

Study information

Verified date June 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this retrospective observational study is to evaluate the performance of the Shared Decision Making Process scale in a sample of patients who have received a decision aid about the decision to screen or not screen for breast cancer, colon cancer, prostate cancer, or lung cancer.


Description:

This is a retrospective observational study that will examine the performance of the Shared Decision Making Process in a sample of patients who made a decision about cancer screening in the last 2 years. Patients from 4 hospitals who have received a patient decision aid for breast, colon, prostate, or lung cancer screening will be screened for eligibility. A random sample of eligible patients will be sent a one-time survey. The survey asks patients about their experiences talking with healthcare providers about the specific cancer screening decision. The survey includes the Shared Decision Making Process scale, knowledge, preferences, decisional conflict and decision regret. The study will obtain 400 completed surveys, or 100 for each cancer topic. The sample consists of patients who received a decision aid for cancer screening within the last two years and meet specific qualifications. All analyses will be conducted separately for each group, and results may be pooled. First, study staff examine the descriptives for the Shared Decision Making Process items. Study staff will also test several hypotheses to examine performance of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date June 24, 2021
Est. primary completion date April 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 80 Years
Eligibility Inclusion Criteria: Breast Cancer group - Female sex - Between ages of 35-55 - No previous diagnosis of breast cancer Colon Cancer Group - Between ages of 45-75 - No previous diagnosis of colon cancer Prostate Cancer Group - Male sex - Between ages of 45-74 - No previous diagnosis of prostate cancer Lung Cancer Group - Between ages of 50-80 - No previous diagnosis of lung cancer Exclusion Criteria: Breast Cancer group - Unable to confirm primary language is English - History of breast cancer - Severe cognitive impairment who cannot consent for themselves Colon Cancer Group - Unable to confirm primary language is English - History of colon cancer - Severe cognitive impairment who cannot consent for themselves Prostate Cancer Group - Unable to confirm primary language is English - History of prostate cancer - Severe cognitive impairment who cannot consent for themselves Lung Cancer Group - Unable to confirm primary language is English - History of lung cancer - Severe cognitive impairment who cannot consent for themselves

Study Design


Intervention

Behavioral:
Decision aid
Healthwise patient decision aids for breast, prostate, colon and lung cancer screening provide information on the pros and cons of cancer screening and guidance in process of selecting a choice.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shared Decision Making Process Measure The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process outcome. Baseline survey
Secondary The 9-item Shared Decision Making Questionnaire The Shared Decision Making Questionnaire measure measures the amount of shared decision making that occurs in an interaction. Scores range from 0-100 where higher values indicate a better shared decision making process occurred. Baseline survey
Secondary Decisional Conflict Tool (SURE) Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates extremely high decisional conflict, 4 indicates no decisional conflict. The number who get score of 4 is reported indicating no decisional conflict. Baseline survey
Secondary Single-Item Measure of Decision Regret Single item asking "If you knew then what you know now, do you think you would make the same decision about [breast cancer screening/colon cancer screening/ prostate cancer screening/lung cancer screening]?" where the last part varies by group.
Response options are:
Definitely yes, Probably yes, Probably No, Definitely No
Baseline survey
Secondary Treatment Choice Single item asking patient "What did you want to do" in regard to (depending on the group) colon cancer screening/ breast cancer screening/ prostate cancer screening/ lung cancer screening. Baseline survey
Secondary Adapted Controlled Preference Scale Single item asking the participants who made the ultimate decision. The categorical response options are:
the patient made the decision
the provider made the decision
both patient and provider made the decision together.
Baseline survey
Secondary Knowledge Multiple choice knowledge items specific for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge. These items are part of the knowledge subscale in the published Decision Quality Instruments. Baseline survey
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