Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants take part in one-on-one interview with research staff and asked questions about participant's health and the disease.

After Cognitive Testing Phase interview, participants may be asked to have a second one-on-one interview with research staff.

Participants may also be asked to complete a questionnaire about the disease, what participant understands about it, and the treatment plan recommended. Participant also asked to give participant's opinion about colorectal cancer follow-up materials.

Cognitive Testing Phase Group: Participants take part in one-on-one interview with research staff and asked questions about participant's health and the disease. The interview may take from 45-60 minutes to complete.

Pilot Testing Phase Group: After Cognitive Testing Phase interview, participants have a second one-on-one interview. The interview will last from 45-60 minutes.

Interview

Participant completes a questionnaire about the disease, what participant understands about it, and the treatment plan recommended. Participant asked to give participant's opinion about colorectal cancer follow-up materials. The questionnaire will take 35-45 minutes.

Questionnaire

George Chang, MD

The goal of this research study to help develop a tool to assist patients in making decisions about care during treatment for colorectal cancer. Information collected during this study will be saved to help develop future studies about patient decision making in cancer treatment.

Cognitive Testing Phase:

If participant agrees to take part in this study, participant will take part in a one-on-one interview where participant will be asked questions about participant's health and the disease. This is called the cognitive testing phase. Notes about the interviews may be kept so that the responses can be reviewed later by the study doctor and research staff.The interview may take from 45-60 minutes to complete.

Pilot Testing Phase:

Participant may be asked to take part in the next phase of the study called the pilot testing phase. If participant takes part in this phase, participant will have a second one-on-one interview. The interview will last from 45-60 minutes.

Participant may also be asked to complete a questionnaire about the disease, what participant understands about it, and the treatment plan recommended for participant. Participant will also be asked to give participant's opinion about colorectal cancer follow-up materials. If participant is asked to complete it, the questionnaire will be completed during the interview, in person. The questionnaire will take 35-45 minutes.

Collection of Information:

Information may be collected from participant's medical record about participant's health, participant's treatment, basic information like participant's age and participant's gender, and the disease. Information will not be collected from all participants.

Length of Study Participation:

If participant takes part in the cognitive testing phase only, participation in this study will end when participant has completed the interview.

If participant takes part in the pilot testing phase, participation in this study will end when participant has completed the second interview and questionnaire if participant was asked to complete it.

This is an investigational study.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing

Colorectal Cancer Surveillance Decision Support Tool: Cognitive and Pilot Testing

Patient-Centered Outcomes Research Institute

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Decision aid

Heather Davey, B.Psych, MPH

Nehmat Houssami, MBBS, PhD

Erin Mathieu, B.Ed, MPH

Andrew Page, BA (Hons)

Richard Taylor, MBBS, PhD

Sian Smith, BSc (Hons)

Phyllis Butow, MPH, PhD

The purpose of the study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography.

The primary aims of the study are to assess the impact of the decision aid on (1) the proportion of women who make an informed choice about whether to continue screening mammography, and (2) the participation rates of screening among women aged 70 years and older.

There are two secondary aims of the study. First, to measure the effect of the decision support tool on women's decisional conflict, anxiety, and knowledge about the issues involved in screening mammography. Second, to compare relationships between a woman's objective and perceived risk of breast cancer with her decision to continue or stop screening mammography.

Screening mammography is recommended for women aged 50-69 years but there is no recommendation for women aged 70 years and older. Therefore the decision to continue or stop having screening mammograms are largely dependent on the importance women place on the perceived benefits and harms of screening.

The decision aid is a paper workbook and worksheet containing information on the outcomes of screening mammography for women aged 70 years and older (based on a published model- Barratt et al. 2005), steps to decision making and values clarification exercise. Currently it is not known if a decision aid with information about the benefits and risks of screening mammography can help women aged 70 years and older to make an informed choice. In addition to delivering benefits to individual women in assisting them to to make an informed choice the decision aid may lead to benefits for service providers such as improved efficiency and cost-effectiveness of screening women in this age group. Thus the impact of a decision aid in the efficiency and cost-effectiveness of screening mammography is an important but untested hypothesis.

Australian Screening Mammography Decision Aid Trial (ASMDAT)

An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.

University of Sydney

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Hematologic Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

PRIME is a decision support tool that uses best-worst scaling to provide a personalized report to providers and patients of their most important treatment priorities

Preference Reporting to Improve Management and Experience (PRIME)

Mireille L Leone

Daniel R Richardson,, MD, MA, MSc

Daniel R Richardson, MD, MA, MSc

The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.

In the last decade, remarkable advances in drug development have led to the approval of 52 new therapies for patients with hematologic malignancies. These new approvals are increasingly enabling clinicians to personalize chemotherapy decisions to achieve what matters most to patients. Therefore, accurately assessing patient preferences is critical to personalizing treatment decisions, particularly among older adults, who face high treatment-related morbidity and/or shorter anticipated survival.

Patient preferences have traditionally been inferred from face-to-face conversations. However, numerous studies, including several systematic reviews, have demonstrated that this process alone is inadequate to reliably capture patient preferences. To support standard shared decision making, multiple stakeholders strongly advocate the development of validated patient-reported measures that accurately capture patients' preferences. In recent guidance about the care of older adults with leukemia, the American Society of Hematology explicitly recommends the development of novel decision support tools to address this growing challenge in patient-centered care. Improved shared decision making has been associated with increased patient-reported quality of care and satisfaction, and a reduction in healthcare utilization.

This study will determine the effectiveness of a novel decision support tool called "PRIME" (Preference Reporting to Improve Management and Experience) to improve the values-concordance of initial treatment decisions. Using best-worst scaling, a validated values-elicitation method, PRIME provides a personalized report to providers and patients of their most important treatment priorities.

In this pragmatic trial, participants will be randomized to receive decision support with PRIME or usual care prior to their first visit with their oncologist. The primary outcome will be clinically significant improvement in values-concordance of the initial treatment decision (on CollaboRATE, a validated 12-point measure).

DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics

The effectiveness of PRIME to improve the value-concordance of treatment decisions in older subjects presenting to hematologic malignancy clinics will be determined by differences in CollaboRATE scores (Percentage in each arm that report perfect scores 15/15) at the post-treatment decision assessment between control and intervention groups.

COLLABORATE scores is a Likert scale questionnaire that includes 3 questions rated from 1 to 5. Higher scores represent better patient engagement.

The secondary outcome will be the difference in CollaboRATE scores (percentage in each arm that report perfect scores 15/15) at the post-treatment decision assessment between control and intervention groups in a subgroup of participants: participants with newly-diagnosed Acute myeloid leukemia, Acute Lymphoblastic leukemia, Diffuse Large B-cell Lymphoma, and Multiple myeloma COLLABORATE scores is a Likert scale questionnaire that includes 3 questions rated from 1 to 5. Higher scores represent better patient engagement.

UNC Lineberger Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator.

computerized online decision support tool

decision support tool

Sue Yom, MD, PhD

This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population.

This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population. The decision support tool is offered by a trained coordinator to the patient and then utilized during an initial consultation. Patients complete forms before and after the visit indicating their level of decisional conflict, satisfaction, and satisfaction with decision. Pre-determined indices of quality of care were also collected by the study team.

National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC

Acceptability and Effectiveness of a Novel Internet -Based Decision-Support Aid Based on the NCCN Non-Small Cell Lung Cancer Patient Guidelines

Change in percentage of patients receiving care according to 6 selected NCCN recommendations

Change in level of decisional conflict will be assessed by the Decisional Conflict Scale (DCS). Assessment will be completed before and after consultation. The DCS is a scale designed to measure patients' uncertainty in making health-related decisions, factors contributing to uncertainty, and patients' perceived effective decision-support. The DCS has 16 items and uses a five-point Likert scale for each item. The total score ranging from 0-64 is divided by 16 and then multiplied by 25 to calculate a final total score with 0 indicating low conflict and 100 indicating high conflict.

Satisfaction will be assessed using the Patient Satisfaction with Health Care Decision (SWD) six-item scale. The SWD will be completed once after the consultation. The range of scoring on this instrument is 0-30, with 30 indicating the highest satisfaction with decision.

Patients' preferred style of decision making with their physician will be assessed using the Decision Making Preference Questionnaire (DMPQ). The DMPQ will be completed once before the consultation. The DMPQ consists of a single question with five choices, ranging from a preference to have the doctor make all of the decisions (passive) to the patient making all of the decisions themselves about their treatment (active) or the intermediate state of shared decision making. There are choices from 1-5 with 5 indicating the most active decision making preference.

Quality of life will be assessed using the FACT-L quality of life instrument, a 44-item self-report questionnaire that uses a five-point Likert scale. The FACT-L will be completed once before the consultation. The FACT-L is graded on a scale from 0-84 with a lung cancer subscale that ranges from 0-24 with the higher scores indicating better quality of life.

Patients' symptoms will be evaluated using the National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17), a 17-item patient-reported questionnaire that uses a five-point Likert scale and is scored from 0-68. It includes three subscales: Disease-Related Subscale, Treatment Side Effects, and Functional Well-Being. The NFLSI-17 will be completed once before the consultation.

By using a post-consultation questionnaire, we will determine the level of agreement between patient and physician with respect to treatments discussed and recommended, prognosis, and expected tolerance.

National Comprehensive Cancer Network

University of California, San Francisco

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Breast Carcinoma In Situ

Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.

Participants explore decision support tool that includes current standard treatment options for DCIS.

The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.

Decision Support Tool with Active Monitoring

The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.

Decision Support Tool without Active Monitoring

Marc D Ryser, PhD

The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS).

Today, guideline concordant care options for patients diagnosed with ductal carcinoma in situ (DCIS) are lumpectomy (with or without radiation treatment) and mastectomy, with optional endocrine therapy. Several ongoing trials are evaluating the safety of active monitoring (AM) as an alternative to immediate surgery for select patient groups. Little is known about women's acceptability of AM after a diagnosis with DCIS.

Here the study team seeks to answer the question: if AM is found to be a safe alternative to immediate surgery, how likely are women to choose it as their first course of treatment?

In this study, women are asked to imagine having recently been diagnosed with DCIS. For some in the intervention arm, in-depth information about surgical options and AM are presented with a web-based decision support tool. After exploring the decision support tool, participants are asked to make a hypothetical treatment choice and to answer a series of additional questions about their decision-making process and personal preferences. Women in the control arm receive a reduced version of the decision support tool that only provides in-depth information about the surgical options (AM is mentioned as an experimental approach).

The overarching hypothesis of this study is that patients who are offered AM as a guideline-concordant care option (a potential future scenario if ongoing trials confirm the safety of AM) are more likely to choose it compared to women in current clinical practice (who receive information about surgical options only).

Primary research question: Compared to presenting active monitoring (AM) as an experimental option, does presenting AM as a guideline-concordant care option increase its uptake as treatment choice?

Secondary research questions: Compared to presenting active monitoring (AM) as an experimental option, does presenting active monitoring as a guideline-concordant care option increase AM acceptability, decrease perceived AM riskiness, and decrease uptake of mastectomy as treatment choice?

Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)

The Mathematics of Breast Cancer Overtreatment: Improving Treatment Choice Through Effective Communication of Personalized Cancer Risk

Measured pre-tool as 5-point Likert scale from "I know very little about breast cancer" (1) to "I know a lot about breast cancer" (5); analyzed as continuous variable.

Measured post-tool as an open text field.

Measured post-tool as categorical 5-point Likert scale from "Not at all confident" (1) to "Very confident" (5); analyzed as continuous variable.

Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables.

Measured post-tool as 9-item scale, each item elicited on a 5-point Likert scale from "Not at all" (1) to "A great deal" (5); for each participant, the average score across 9 items is recorded and analyzed as a continuous variable.

Measured post-tool as a 7-item scale, each item elicited on a scale from "Rarely" (1) to "Often" (3).

Measured post-tool. Single score derived from 4 items, each scored as correct or incorrect. Correct answers are summed for a total "graph literacy score" (0-4).

Measured post-tool as categorical 6-point Likert scale from "I strongly lean toward waiting and seeing" (1) to "I strongly lean toward taking action" (6); analyzed as continuous variable.

Measured post-tool as an 8-item scale, each item elicited on a 5-point Likert scale from "Strongly disagree" (1) to "Strongly agree" (5).

Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from "Never" (0) to "Always" (5).

Measured post-tool as a 4-item scale, each item elicited on a 6-point Likert scale from "Not at all important compared to other things in my life" (1) to "The very most important thing in my life" (6).

Measured post-tool as a 3-item scale, each item elicited on a 5-point Likert scale from "Not at all" (1) to "Almost all the time" (5)

Self-reported health status (visual analog scale, 0-100).

Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.

Acceptability was ascertained using 1-5 Likert scale. Acceptability, asked in terms of comfort with a given treatment choice, was anchored at 1="Not at all comfortable" and 5="Very comfortable." The outcome was dichotomized using responses of 4 or 5 to represent "Acceptable".

Perceived risk outcome was ascertained using 1-5 Likert scale. Perceived risk was asked for active monitoring only, and was anchored at 1="Not at all risky" and 5="Very risky". The outcome was dichotomized using responses of 4 or 5 to represent "Risky".

Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.

Measured pre- and post-tool as a categorical 5-point Likert scale from "I know very little about DCIS" (1) to "I know a lot about DCIS" (5); analyzed as continuous variable.

National Cancer Institute (NCI)

Duke University

Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.

Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.

Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.

Standard Treatment Options + Active Monitoring

Participants explore decision support tool that includes current standard treatment options for DCIS.

Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.

Standard Treatment Options

Total

Age, Continuous

50-64 years

65-79 years

Age, Customized

Sex: Female, Male

White

Black

Other

Race/Ethnicity, Customized

In Relationship

Married

Divorced

Separated

Single

Marital Status

Some High School

High School

Bachelor's Degree

Master's Degree

Professional Degree (e.g., MD, JD)

Doctorate Degree (e.g., PhD)

Education

Extra for special

Just enough

Cut back to pay bills

Difficulty paying bills

Household Finances

Self-Reported Health Status measured on a visual analog scale (0-100%), with 0 being the worst outcome and 100 being the best outcome.

Self-Reported Health Status, Median (Q1, Q3)

Personal Cancer History

Family Cancer History

This categorical 6-point Likert scale ranges from "I strongly lean toward waiting and seeing" (1) to "I strongly lean toward taking action" (6). The scale captures the extent to which individuals are "medical maximizers" who are predisposed to seek health care even for minor problems, versus "medical minimizers" who prefer to avoid medical intervention unless it is necessary.

Maximizer Minimizer Scale, Median (Q1, Q3)

Single score derived from 3 items, each scored as correct or incorrect. Correct answers are summed for a total "graph literacy score" (0-3). Lower scores indicate worse outcomes, and higher scores indicate better outcomes.

Graph Literacy Score (0-3), Median (Q1, Q3)

5-point Likert scale from "I know very little about breast cancer" (1) to "I know a lot about breast cancer" (5).

Pre-tool Knowledge (1-5): Breast Cancer

5-point Likert scale from "I know very little about DCIS" (1) to "I know a lot about DCIS" (5).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing	NCT03180411	Colorectal Canc...	Interview Questionnaire	18 Years -	M.D. Anderson Cancer Center
Australian Screening Mammography Decision Aid Trial (ASMDAT)	NCT00247442	Breast Neoplasm...	Decision aid	70 Years -	University of Sydney
Australian Screening Mammography Decision Aid Trial (ASMDAT)	NCT00247442	Breast Neoplasm...	Decision aid	70 Years -	University of Sydney
Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing	NCT03180411	Colorectal Canc...	Interview Questionnaire	18 Years -	M.D. Anderson Cancer Center
DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics	NCT06296368	Hematologic Mal... Lymphoma Multiple Myelom... Leukemia Blood Cancers	Preference Repo...	60 Years -	UNC Lineberger Comprehensive Cancer Center
National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC	NCT03982459	Non-small Cell ...	decision suppor...	18 Years -	University of California, San Francisco
Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)	NCT03775213	Ductal Carcinom...	Decision Suppor... Decision Suppor...	50 Years - 79 Years	Duke University
Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)	NCT03775213	Ductal Carcinom...	Decision Suppor... Decision Suppor...	50 Years - 79 Years	Duke University

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