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Completed

NCT Number: NCT04601272

Evaluating the Shared Decision Making Process Scale in 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.

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Key information

Conditions

Breast Cancer Screening Colon Cancer Screening Prostate Cancer Screening

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Decision aid

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The 9-item Shared Decision Making Questionnaire

    Time frame: Baseline survey

    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.

  2. Decisional Conflict Tool (SURE)

    Time frame: Baseline survey

    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.

  3. Single-Item Measure of Decision Regret

    Time frame: Baseline survey

    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

  4. Treatment Choice

    Time frame: Baseline survey

    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.

  5. Adapted Controlled Preference Scale

    Time frame: Baseline survey

    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.

  6. Knowledge

    Time frame: Baseline survey

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Evaluating the Performance of the Shared Decision Making Process Scale in Patients Making Cancer Screening Decisions

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2020
Registry last updated
Mar 30, 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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