Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, Local

The aim of biopsy is to sample the thyroid nodule so that it can be tested for cancer. A biopsy is done with a small needle in an office. If the biopsy result shows the nodule is unlikely to be cancer, the next step is check-ups every 6 months to a year for two years followed by additional checkups that occur less frequently.

If the biopsy result shows the nodule may be cancerous, usual treatment is surgery to remove part or all of the thyroid gland. Afterwards, regular check-ups and ultrasounds follow. Surgery may be outpatient or overnight stay. Recovery takes a couple weeks or more. Time in the hospital and recovering depends on the type of operation and any side-effects.

The aim of Active Monitoring is to monitor the thyroid nodule closely. An ultrasound and a check-up with a clinician are done every six months for two years, then less often after that.

If no changes in the nodule or new abnormal lymph nodes are seen, Active Monitoring continues and surgery and its side-effects are avoided. If changes in the nodule are seen on ultrasound, they are explained at the visit. The doctor may recommend that continued Active Monitoring or recommend a biopsy to investigate the changes. The biopsy result may suggest Active Monitoring can be continued, or may indicate surgery should be done, as described above.

Local anesthetic is usually given and a small needle is used to take cells from the thyroid under ultrasound guidance through several 'passes' and placed into specialized media for pathology evaluation.

Biopsy

Ultrasound and a check-up at 6 months. Depending on ultrasound results, either biopsy and further care (as for the treatment arm called 'biopsy'), or continue with active monitoring.

Active Monitoring

Tayyaba Sarwar, MD, MS

Louise Davies, MD, MS

This is a pilot study to compare two ways of managing newly identified thyroid nodules that are likely to be cancerous based on ultrasound result and which under usual care would undergo immediate biopsy.

The main goals of this pilot study are 1) compare anxiety at 6 months in each treatment arm using the validated instrument Anxiety-CA, 2) measure thyroid quality of life in each treatment arm

Participants will be randomized to one of two groups:

1. immediate biopsy (usual care)
2. Active monitoring (serial ultrasound based monitoring and close clinical follow-up)

TRAIL Study: Feasibility and Pilot

ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot

Rate of anxiety will be measured using Anxiety-CA instrument PROMIS-Anxiety Short form. Each question has five response options ranging in value from one to five. (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the adult PROMIS Anxiety 7a short form, a raw score of 10 converts to a T-score of 46.7 with a standard error (SE) of 2.6.

Representativeness will be compared in terms of age in years (continuous), biological male or female (categorical), and race/ethnicity (categorical).

Rate of completion of patient reported outcomes and number of participants who withdraw from study or are lost to follow-up.

A needle biopsy is a procedure to obtain samples of tissue or cells from thyroid nodule or lymph nodes to reveal whether a nodule is a benign tumor or cancer. Bethesda classification (ordinal) will be used. The Bethesda system identifies six diagnostic categories on thyroid nodule cytopathology. Each category is linked to a malignancy risk. Categories are as follows: Category I (Nondiagnostic), Category II (Benign), Category III (Atypical of undetermined significance), Category IV (Suspicious for follicular neoplasm), Category V (suspicious for malignancy), Category VI (Malignant). If Cytology results shows Bethesda V or VI, then histology (categorical) will be performed.

Histologic examination (Categorical) will be performed to make diagnosis. Histology is a medical practice to review tissues under microscope to identify potential changes in a suspected tissue. The histological exam will help to diagnose if cancer is present or not and to find out the histologic type of the suspected tissue. The histologic types for thyroid cancer are as follows: Papillary, follicular, oncocytic, medullary, and anaplastic.

If patient is on active monitoring, then the nodule size will be followed with ultrasound exams.

The ThyPRO survey is a quality-of-life measure designed to evaluate how thyroid disease has affected the participant's life. Domains being used from this measure for the pilot study include symptoms (8 items), tiredness (2 items), and memory and concentration (3 items). Answer choices range from 1 (not at all) to 5 (very much) with higher scores indicating worse quality of life.

American College of Radiology

Dartmouth College

Dartmouth Cancer Center

Dartmouth-Hitchcock Medical Center

Staff Physician - Section of Otolaryngology Head & Neck Surgery

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Neoplasms

Breast Carcinoma In Situ

DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)

DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)

Surgery +/- radiation choice for endocrine therapy

Surgery

Shelley Hwang, MD, MPH

Ann Partridge, MD, MPH

Alastair Thompson, MD

This study looks at the risks and benefits of active monitoring (AM) compared to surgery in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AM approach does not yield inferior cancer or quality of life outcomes compared to surgery.

Overdiagnosis and overtreatment resulting from mammographic screening have been estimated to be as high as 1 in 4 patients diagnosed with breast cancer although the absence of standard definitions for measuring overdiagnosis has led to much uncertainty around this estimate. The national health care expenditure resulting from false positive mammograms and breast cancer overdiagnosis has been estimated to approach $4 billion annually. There is general consensus that much of this burden derives from the treatment of DCIS; for those estimated 40,000 women per year whose DCIS may never have progressed even without treatment, medical intervention can only harm. In those women who undergo surgical management of DCIS, there is risk of developing persistent pain at the surgical site, with estimates ranging from 25-68%. Importantly, persistent pain after lumpectomy may be as prevalent as that after total mastectomy. Persistent postsurgical pain is rated by patients as the most troubling symptom, leading to disability and psychological distress, and is often resistant to management. Although prospective population-based data have demonstrated significant patient and surgical focus on pain with remarkably high levels of chronic pain 4 and 9 months after breast surgery, much of these data have been collected in women with invasive cancer, with little data directly relevant to patients with DCIS.

The overarching hypothesis of the study is that management of low-risk DCIS using an active monitoring (AM) approach does not yield inferior cancer or quality of life outcomes compared to surgery.

Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS

Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

Patient medical information both, associated with biologic specimens or not, is confidential and may only be disclosed to third parties as permitted by the Informed Consent Form (ICF) (or separate authorization for use and disclosure of personal health information) which has been signed by the patient, unless permitted or required by law. Data derived from biologic specimen analysis on individual patients will in generally not be provided to study investigators unless a request for research use is granted. The overall results of any research conducted using biologic specimens will be available in accordance with the effective Alliance Foundation Trial (AFT) policy on study data publication.

Determine the rate of use of breast MRI imaging compared to use of other breast imaging techniques

Determine the rate of biopsies performed during follow-up of patients with DCIS

Determine the rate of the performance of radiation therapy on patients with DCIS

Determine the rate of the use of chemotherapy on patients with DCIS

A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate commonly reported menopausal symptoms

Evaluated with the Brief Pain Inventory, a well-validated general measure of pain and disability worst pain, least pain, and interference

Breast specific pain will be measured by the Breast Cancer Pain Questionnaire (BCPQ); the BCPQ includes assessment of pain severity, pain frequency (how many days/week), and pain location (breast, arm, side, axilla), from which a Pain Burden Index (PBI) can be calculated

Body image will be evaluated by the Breast-Questionnaire, a validated instrument to evaluate outcomes following surgery, will be used to evaluate satisfaction with body image

The Decision Regret Scale will measure how women perceived their DCIS treatment decision. The SURE scale, which is composed of four items from the Decisional Conflict Scale will be used to measure patients' uncertainty about which treatment to choose and factors contributing to uncertainty (feeling uninformed, unclear values, and unsupported in decision-making).

DCIS and breast cancer knowledge will be measured with items adapted from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) as well as questions developed specifically for a study that assessed DCIS knowledge and risk perceptions. The investigators will assess risk perceptions in women with DCIS using questions developed by Lerman and Croyle that will measure risk perceptions in relation to psychosocial outcomes in women with DCIS

Measured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)

To assess communication with physicians about DCIS management options, the investigators will adapt items used in a prior study of surgical decision-making, including the extent to which their physician talked to them about AM vs. surgery. Additionally the investigators will ask about sources of information for the management of their DCIS

The investigators will adapt items from the National Health Interview Survey and the Cancer Outcomes Research and Surveillance (CanCORS) Study to assess financial burden. The investigators will also ask women to Cancer Care estimate out of pocket expenses attributed to their DCIS diagnosis.

Employment status will be assessed using a measure that is being added to the Alliance Patient Questionnaire as it has been tested and validated in breast cancer populations.

Four items from the Quality of Life in Adult Cancer Survivors (QLACS) scale will be adapted to evaluate frequency (1=never; 7=always) of worries about DCIS, including concerns about future breast events and death from DCIS

To compare the number of patients that develop ipsilateral invasive cancer that received surgery to the number of patients that were placed on active monitoring after 2 years of follow-up

Measured by five dimensions questionnaire (EQ-5D)

Measured by the State Trait Anxiety Inventory (STAI) scale

Measured by the Center for Epidemiologic Studies Depression Scale (CES-D) 10

Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).

Assessment of feelings of uncertainty using the Intolerance of Uncertainty Scale (Short-form), which has been used in studies of active monitoring in the prostate cancer setting.

To compare the impact of surgery vs. AM on the number of mastectomies performed in patients with DCIS

To compare the impact of surgery vs. AM on the number of breast conservation surgeries performed in patients with DCIS

To compare the impact of surgery vs. AM on the rate of development of contralateral invasive cancer in patients with DCIS

To compare the impact of surgery vs. AM on the overall survival rate in patients with DCIS

To compare the impact of surgery vs. AM on the breast cancer specific survival rate in patients with DCIS

To determine the number of DCIS patients in the surgery arm that develop ipsilateral invasive cancer

To determine the number of DCIS patients in the AM arm that develop ipsilateral invasive cancer

Patient-Centered Outcomes Research Institute

Duke University

Dana-Farber Cancer Institute

M.D. Anderson Cancer Center

New York University

Washington University School of Medicine

Alliance Foundation Trials, LLC.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Genomic Health's OncotypeDX® Prostate Cancer Assay is a commercially available laboratory test that measures the activity of certain genes in prostate cancer. The purpose of this study is to better understand how the use of this test result impacts or affects treatment decisions for men newly diagnosed with low risk prostate cancer, their confidence in the treatment decision, and the effects and side effects of the treatment chosen on certain aspects of Quality of Life. This study will also determine what percentage of men choosing an active monitoring program as prescribed by their doctor remain on Active Surveillance and have avoided any treatment at one year after diagnosis after receiving the assay result.

This is a multicenter observational study that evaluates eligible patients who will submit prostate cancer diagnostic biopsy tissues for Oncotype DX Prostate Cancer Assay testing. A physician treatment recommendation will be made and the assay is ordered. The physician will review clinical data, the GPS report and discuss treatment options with the patient. At the following visit, a shared physician-patient treatment decision (immediate treatment or AS) will be made.

Men selecting AS as primary treatment will be followed to assess persistence on AS.

There is no required or standardized AS protocol for this study and the intensity of surveillance will be at the discretion of the investigator. Patients will not be required, but may undergo a standard TRUS guided surveillance biopsy at one year. In this study, the Oncotype DX Prostate Cancer Assay will be assessed on the diagnostic biopsy only and will not be assessed on subsequent biopsies.

fixed paraffin embedded tissue (FFPE) blocks \[retained up to 2 years\], FFPE sectioned slides \[retained up to 2 years\], unstained slides \[retained up to 2 years\], and/or RNA \[retained up to 20 years\].

Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance

A Prospective Multi-center Observational Trial to Assess Persistence on Active Surveillance When Using the OncotypeDX® Prostate Cancer Assay

The analysis will estimate the absolute magnitude of the rates of persistence at these two time points, and the change between the two rates. The rate of persistence, at the particular timepoint, will be calculated as the proportion of patients who remain on Active Surveillance as of the doctor visit at the time. The rate of persistence will range from 0% to 100%, with 100% indicating all evaluable patients stay on Active Surveillance at the particular timepoint, and 0% indicating no evaluable patient on Active Surveillance.

Genomic Health®, Inc.

Symptoms and General Pathology

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Metastasectomy

Active monitoring

Tom Treasure, MD, MS, FRCS

Patients who have been treated successfully for bowel cancer (colorectal cancer) sometimes go on to develop nodules of disease in another part of the body. If this disease is found to be related to the original cancer it is called a metastasis. Some patients develop one or more metastases particularly in the lungs or the liver.

There is a growing trend to remove lung metastases with an operation, in the belief that this will help patients live longer, however there have not been any scientific studies to prove this. There is also very little published information about the side effects of this surgery and how it affects subsequent daily living. This is a feasibility study to determine whether it will be possible to conduct a large randomised controlled trial investigating the value of pulmonary metastasectomy (surgery to remove lung metastases) in patients who have been successfully treated for colorectal cancer. There is a two stage consent and randomisation process. Firstly, patients will be invited to consent to having a full range of investigations to assess their suitability for surgery. If found to be suitable, they will then be invited to consent to randomisation between active monitoring of their disease or active monitoring with pulmonary metastasectomy. Patients will be followed up regularly for 5 years to assess their disease status and to measure their quality of life and lung function.

Colorectal cancer is one of the three commonest solid tumours. Approximately 100 cases are diagnosed each day in the UK. In 2006, 37,514 cases of colorectal cancer were diagnosed.

The increasing use of CT scans in routine follow up of patients has led to earlier diagnosis of isolated and/or subclinical lung nodules and there has been widespread adoption of pulmonary metastasectomy in selected cases. A survey of practice in Europe showed that pulmonary metastasectomy is very commonly performed but criteria vary widely. About 300 such operations were being carried out annually in the UK when PulMiCC opened as a 'feasibility' study.

Although well-established in clinical practice there have been no previous randomised controlled trials of the effect of lung metastasectomy on survival and there is doubt as to its clinical effectiveness. The most recent systematic review and meta-analysis concludes that pulmonary metastasectomy is associated with a high likelihood of recurrence, with doubling of the recurrence rate with each of three adverse prognostic factors: (i) more than one metastasis, (ii) an interoperative interval (primary resection to lung metastasectomy) less than three years, (iii) elevated CEA.

In a prospective registry capturing more than 60% of Spanish practice for a two year period these limits were commonly exceeded.

In an RCT it has been shown that recurrence can be detected earlier with CT and/or CEA surveillance and as a result more liver and lung metastasectomy operations were performed. However, these operations did not provide any survival benefit, within the RCT. The uncertainty about the practice has been set out in the British Medical Journal in 2014.

Pulmonary metastasectomy is thus part of a bigger question about effectiveness of surgery for metastases from colorectal cancer.

There are known unfavourable prognostic factors which include the number of metastases and the length of time they take to become evident radiologically: (a) a solitary nodule appearing after a long interval is will be removed in most instances, (b) surgery is rarely advocated when there are multiple metastases present at the time of surgery on the primary colorectal cancer or appearing soon after.

These scenarios represent opposite ends of the continuum of favourable to adverse factors for survival after resection of pulmonary metastases. Most patients operated on fall between these extremes and it is evident that if there is a "yes" towards one end of the continuum and "no" towards the other that there must be cross over zone where there is clinical uncertainty. PulMiCC aims to investigate the outcome following pulmonary metastasectomy in patients where there is accepted clinical uncertainty, to provide evidence to guide practice in the future.

It has also been shown previously that trials requiring patients to consider randomisation between treatments that appear very different, as in this instance between surgery or no surgery, can experience recruitment difficulties. This is because potential participants may have acquired a strong preference for one of the treatments over the other and they are not willing to accept the possibility of being allocated to the less non-preferred option alternative.

There can also be problems of bias if one treatment is mentioned to the patient before the option of a trial is introduced; the first mentioned treatment may be perceived to be preferred between doctor and patient. This trial has been designed to overcome these potential difficulties and maximise recruitment as follows.

Colorectal cancer patients presenting with pulmonary metastases will first be consented for registration into the study. This consent is to undergo evaluation according to the trial protocol as part of the work up for consideration by the MDT. Following evaluation, the MDT will consider how they would normally treat each patient according to their standard local practice. Patients eligible for randomisation will be those for whom clinical uncertainty exists as to whether surgery would be of benefit. This trial design was successful in a study of the feasibility of randomising patients in a trial of mesothelioma surgery.

The time taken for patients to undergo the full range of tests for evaluation gives them time to think carefully about the possible treatment options and discuss them with their doctor. In addition to the patient information leaflet, patients will be invited to take home a DVD explaining the trial in detail, which can be watched as often as the patient likes. It is hoped that those who are ultimately identified as eligible for randomisation will have fewer anxieties because of their extended opportunity to consider the trial.

Local site research staff involved in recruiting patients will attend a training session to learn the best method of informing patients about the trial before recruitment commences.

A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer

We wish to measure the monthly recruitment rate from approximately 11-12 centres over 2 years. This feasibility study aims to determine whether it will be possible to recruit sufficient patients to conduct a larger randomised trial which would be powered to measure survival as the primary outcome.

Overall survival, Relapse free survival, Lung function (measured by FEV1), Patient reported quality of life (STAI, FACT-An-L and EQ-5D questionnaires), Health economic assessment

Royal Brompton & Harefield NHS Foundation Trust

University of Cambridge

University of Sussex

University College, London

Conformal radiation therapy External beam radiation therapy

Active monitoring of prostate specific antigen levels and disease surveillance

Radical prostatectomy

Conformal radiation therapy, external beam

Conformal radiation therapy

Active monitoring of Prostate specific antigen levels and disease surveillance

Freddie C Hamdy

RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.

PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.

OBJECTIVES:

* To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.
* To investigate disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.
* To investigate the psychosocial impact of cancer detection and treatment on these patients, including generic health status, quality of life, and sexual function.
* To estimate the resource use and costs of detection, treatment, and follow-up.
* To compare costs and outcomes of treatment in terms of survival and health-related quality of life.
* To collect samples suitable for basic science research (ProMPT study).

OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (6, 7, 8-10), and average result of recruitment and first biopsy prostate-specific antigen (PSA) tests (\< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are randomized or select a treatment to be followed up in a cohort study.

Prostate Testing for Cancer and Treatment

The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer

University of Bristol

University of Oxford

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)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TRAIL Study: Feasibility and Pilot	NCT06220656	Thyroid Nodule Thyroid Neoplas... Thyroid Cancer	Biopsy Active Monitori...	18 Years -	Dartmouth-Hitchcock Medical Center
Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS	NCT02926911	DCIS Ductal Carcinom...	Surgery Active Monitori...	40 Years - 99 Years	Alliance Foundation Trials, LLC.
Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance	NCT03502213	Prostate Cancer		50 Years -	Genomic Health®, Inc.
A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer	NCT01106261	Colorectal Canc... Pulmonary Metas...	Metastasectomy Active monitori...	16 Years -	University College, London
Prostate Testing for Cancer and Treatment	NCT02044172	Prostate Cancer	Radical prostat... Conformal radia... Active monitori...	50 Years - 69 Years	University of Oxford
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
Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS	NCT02926911	DCIS Ductal Carcinom...	Surgery Active Monitori...	40 Years - 99 Years	Alliance Foundation Trials, LLC.
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
A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer	NCT01106261	Colorectal Canc... Pulmonary Metas...	Metastasectomy Active monitori...	16 Years -	University College, London

Spots Global Cancer Trial Database for active monitoring