Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

NCT ID: NCT04601272

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2021-06-24

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.

Conditions

Breast Cancer Screening; Colon Cancer Screening; Prostate Cancer Screening

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Breast Cancer Screening

Women between the ages of 35-55 when they received a decision aid for breast cancer screening with no prior diagnosis of breast cancer. These people will see items only pertaining to breast cancer screening.

Decision aid

Intervention Type: BEHAVIORAL

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.

Colon Cancer Screening

Men and women between the ages of 45-75 when they received a decision aid for colon cancer screening with no prior diagnosis of colon cancer. These people will see items only pertaining to colon cancer screening.

Decision aid

Intervention Type: BEHAVIORAL

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.

Prostate Cancer Screening

Men between the ages of 45-74 when they received a decision aid for prostate cancer screening with no prior diagnosis of prostate cancer. These people will see items only pertaining to prostate cancer screening.

Decision aid

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karen Sepucha

Director, Health Decision Sciences Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen R Sepucha, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2005P002282

Identifier Type: -

Identifier Source: org_study_id