Clinical trial NCT04601272: Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions
Official title: Evaluating the Performance of the Shared Decision Making Process Scale in Patients Making Cancer Screening Decisions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Screening
Colon Cancer Screening
Prostate Cancer Screening
Keywords: decision making
decision aids
decision quality instruments
shared decision making
cancer screening
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-10-23
Enrollment: 240
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who received a cancer screening decision aid in the last 2 years while receiving care at 4 hospitals within a major healthcare network.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Shared Decision Making Process Measure
timeFrame: Baseline survey
Secondary outcomes:
measure: The 9-item Shared Decision Making Questionnaire
timeFrame: Baseline survey
measure: Decisional Conflict Tool (SURE)
timeFrame: Baseline survey
measure: Single-Item Measure of Decision Regret
timeFrame: Baseline survey
measure: Treatment Choice
timeFrame: Baseline survey
measure: Adapted Controlled Preference Scale
timeFrame: Baseline survey
measure: Knowledge
timeFrame: Baseline survey
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen R Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References: