Breast Cancer ScreeningNCT04601272
Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions
An observational study of Breast Cancer Screening and Colon Cancer Screening, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening, Colon Cancer Screening, Prostate Cancer Screening
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2020to 24 Jun 2021
- Phase
- Observational
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Breast Cancer group
- Female sex
- Between ages of 35-55
- No previous diagnosis of breast cancer
- Colon Cancer Group
- Between ages of 45-75
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluating the Performance of the Shared Decision Making Process Scale in Patients Making Cancer Screening Decisions
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.
Read the 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.
- Being tested
- Decision aid
- Keywords
- decision making, decision aids, decision quality instruments, shared decision making, cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Decision aid | |
| 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. Receives: Behavioral: Decision aid | |
| 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. Receives: Behavioral: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline survey
Secondary outcomes (6)
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.
Measured: Baseline survey
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.
Measured: Baseline survey
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
Measured: Baseline survey
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.
Measured: Baseline survey
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.
Measured: Baseline survey
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.
Measured: Baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start29 Sep 2020
- Primary completion16 Apr 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen R Sepucha, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601272
- Sponsor's protocol ID
- 2005P002282
- Status last verified
- Jun 2022
- First submitted
- 29 Sep 2020
- Last updated
- 30 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will create a complete, cleaned, de-identified copy of the final data set for each cancer screening topic.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Performance of the Shared Decision Making Process Scale in Patients Making Cancer Screening Decisions
- ClinicalTrials.gov ID
- NCT04601272
- Acronym / sponsor ID
- 2005P002282
- Keywords
- decision making, decision aids, decision quality instruments, shared decision making, cancer screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Posted 30 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Screening | – | Behavioral: Decision aidWomen 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. |
| Colon Cancer Screening | – | Behavioral: Decision aidMen 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. |
| Prostate Cancer Screening | – | Behavioral: Decision aidMen 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- Breast Cancer group
- Female sex
- Between ages of 35-55
- No previous diagnosis of breast cancer
- Colon Cancer Group
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidHealthwise 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. | Behavioural | Breast Cancer Screening, Colon Cancer Screening, Prostate Cancer Screening |
Primary outcome
Shared Decision Making Process Measure
Time frame: Baseline survey
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.
6 secondary outcomes
The 9-item Shared Decision Making Questionnaire
Time frame: Baseline survey
Decisional Conflict Tool (SURE)
Time frame: Baseline survey
Single-Item Measure of Decision Regret
Time frame: Baseline survey
Treatment Choice
Time frame: Baseline survey
Adapted Controlled Preference Scale
Time frame: Baseline survey
Knowledge
Time frame: Baseline survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The study team will create a complete, cleaned, de-identified copy of the final data set for each cancer screening topic.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen R Sepucha, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Screening and Colon Cancer Screening, run by Massachusetts General Hospital at 1 site 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 14 inclusion and 16 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 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2023). 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?
Shared Decision Making Process Measure (time frame: Baseline survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2023.