Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

* Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP.
* One month or at the next visit following the decision, the patient will be asked to complete a research survey using REDCap.

* Patients randomized to standard of care will receive the standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months for patients with MBC who have not made a treatment decision until a treatment decision is made.
* One month or at the next visit following the decision, the patient will be asked to complete a post-treatment survey using REDCap.

includes standard of care questions with additional decision-making questions

Intervention-specific Carevive questionnaire

includes the standard of care questions that are already in place for Carevive questionnaires

Standard of Care questionnaire

Gabrielle B Rocque, MD

The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention will be piloted in a RCT with 140 early stage breast cancer (EBC) and 140 metastatic breast cancer (MBC) patients to assess impact. Subjects will be enrolled across two sites. Our primary outcome will be the increase in percentage of patients reporting a perception of shared decision-making.

Aim.1: The primary outcome will be to evaluate the impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making.

Aim 2: To evaluate the impact of the SDM intervention on provider outcomes including the percentage of providers perceiving SDM with the patient, number of treatment options offered to patients, the proportion of times that clinical trials are offered to patients, the use of NCCN guideline-based treatment, and self-report of treatment plan use.

Aim 3: Secondary fidelity and provider outcomes from audio recording will include whether providers elicit: any patient preferences during treatment planning, preferences related to physical side effects or efficacy, or preferences related to other aspects of the patient experience. We will also assess whether providers use the TP in the decision-making discussion and whether providers discuss or offer clinical trials to the patient.

Two sites (UAB and MCI) will conduct the RCT of 140 patients with MBC and 140 patients with EBC comparing use of SDM TPs delivered during decision-making visits compared to TPs delivered post-decision-making. The Carevive Care Planning System (CPS) treatment planning software will be used at all clinical sites to provide treatment care plans to patients with breast cancer. This software platform, which is currently utilized after decision-making, will be modified within this project to facilitate SDM through the creation of a SDM TP utilized during decision-making. Together, the patients and physician will be able to review the patient's decision-making style, patient's desire for prognostic information treatments, and patient preferences about decision-making.

Participants will be compensated in the form of a $20 gift card at the time of consent. After the patient provides consent, the research coordinator will evaluate the electronic medical record (EMR) for completion of standard of care elements necessary for the generation of TPs. At UAB, an embedded form with the necessary information for TP generation is completed in the EMR as part of standard of care by clinical providers. If this form has not been completed, the research coordinator may either notify the provider to initiate form completion or complete this form within the EMR to ensure availability at the time of the treatment decision. If the research coordinator completes this form, it will be reviewed by a clinical provider. The completion of the form prior to consent for patients approached by telephone will be necessary to allow new patients to receive TPs if a decision is made at their initial visit. For other sites who do not use EMR forms, the clinical information will be entered directly into the Carevive platform by either the research coordinators or clinical staff.

We will survey patients as described above on an iPad using the Carevive platform at baseline and every 6 months until a treatment decision is made (intervention or standard-of-care). Post-treatment surveys will be administered using a REDCap survey. To minimize participant burden, we will allow patients to complete surveys in-person during routine clinic visits, by telephone, or at home using an e-mailed link to the survey based on patient preference. To accommodate patients who would like to complete surveys in-person, we will allow for a 1-month window around the initial 6-month survey (for those without a treatment decision within 6 months) and a 2-week window around post-treatment survey. We will record if surveys are completed by email, telephone, or in-person.After each decision-making encounter, the physician will be asked to complete a patient-specific survey in REDCap. For standard of care patients, this will include the Control Preferences Scale. For intervention patients, the survey will include both the Control Preferences Scale and three study-specific questions about use of TP during decision-making.

Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP.

Patients randomized to standard of care will receive their standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months until a treatment decision is made.

Enhancing Shared Decision-Making in Breast Cancer

Impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making

American Cancer Society, Inc.

Carevive Systems, Inc.

University of Alabama at Birmingham

Assistant Professor

Metastatic Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

Early Stage Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

Clinic Provider Participants will participate in a focus group on the topic of Shared Decision Making. This will be a one time, focus group interview with a trained moderator.

Non-UAB Provider Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

Early Stage Breast Patient Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

Patient Advocate Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

Physician Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

Early Stage Breast Patient Participants will be interviewed to provide feedback on a decision making tool (video). This will be a one time, one-on-one interview with a trained interviewer.

The purpose of this study is to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care.

Secondly, to further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial).

Qualitative Interview or Focus group discussions

Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).

Phase 1:

Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions will be used to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care. Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct semi-structured interviews/discussion groups with patients, navigators, nurses, and physicians to elements important to decision-making.

Phase 2:

Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically develop the TP intervention using the Ottawa Decision Support Framework. Investigators will test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an iterative process.

Phase 3:Further explore decision-making related to reducing amount of chemotherapy for patients with good prognosis.

Phase 1:

Investigators will use patient interviews and navigator, nurse, and physician focus group discussions to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care. Patients will be recruited from the medical oncology clinic. Patients will be identified by their primary oncologist. All eligible patient will be provided with a study information flyer. All patient participants will be asked to provide written informed consent prior to participation in interviews; provider participants will be provided with Information sheets prior to focus groups by a research coordinator. Participants in Group 1 will be asked to complete a demographic form. The demographic forms for patients, navigators, nurses, and medical oncologists are included in Appendix B. Demographic form will include questions about your age, sex, race and education. The demographic form will take 5 minutes to complete. At study entry, descriptive data including patient demographics (age, sex, race), breast cancer characteristics (subtype, line of therapy, specific treatment offered, prior treatments received), physician will be collected to provide clinical context for the analysis. The patients will be interviewed at the patient's next appointment (either with the physician or in the infusion center) or the patients can schedule to come on an off clinic day of their preference. The study coordinators will offer each patient the option to complete the consent form at home. If they decide to complete the consent form at home investigators will follow up with by contacting them on the telephone to ensure that the consent form was completed and to confirm their interview at their next clinic visit or an off day of their preference. This 30 minute to an hour interview will take place in a private meeting room within the UAB Comprehensive cancer center. The patient interviews will be audio-recorded by using a digital audio recorder.

Phase 2:

Patients will be recruited from the medical oncology clinic. Patients will be identified by their primary oncologist. A trained research coordinator will consent the patient during a routine clinic visit. This group will consist of 5 new patients who did not participate in Group 1 patient interviews. Descriptive data including patient name and medical record number will be collected on a tracking sheet. No other personal identifiable information will be collected. This 30-minute interview will take place in the clinic room or a private room within the UAB Comprehensive cancer center (based on patient preference). The researcher will provide the patient with the iPad for completion of baseline patient-reported outcome questionnaires using the Carevive® platform for a test patient in a test environment which will not be linked to the patient's medical record. The intervention questionnaire will include standard questions used to routine treatment planning at UAB/MCI as well as any study-specific questions generated from Phase I above. This will allow feedback on the questionnaire itself. The research coordinator will then provide the patient with an example TP that includes responses to the questionnaire. The study PI will review the electronic or a printed version with the patient to get feedback on the acceptability of the TP, content of the TP, and the best approach to utilizing the TP. This process may be modified based on results of our qualitative analysis.

Investigators will conduct separate focus groups with each provider group. This will include 7 breast medical oncologists, 10 patient navigators, and 10 nurses (5 clinic nurses who work directly with the breast oncologists and 5 infusion nurses).

Phase 3:

The purpose of this phase is to (1) further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial). This study will include both patients and patient advocates, who bring a broad perspective to how the patient experience should be considered in research. Interviews with patients, patient advocates, and physicians will be conducted either in person or by phone/zoom based on patient preference. In person patient interviews will be conducted (1) in the UAB Medical Oncology outpatient clinic rooms or in private room in the UAB Comprehensive Cancer Center (based on patient preference for location). In person patient advocate or physician interviews will be conducted at in-person meetings of the Eastern Cooperative Group, which are routinely attended by the patient advocates and physicians in the private room or location of the advocate's choice.

Patient Participant Groups are women only

Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)

Shared decision making occurs when patients are informed of risks and benefits associated with treatment options and partner with their oncologist to incorporate their personal preferences and values into decision-making. Shared decision making in medicine can improve quality of care and reduce costs. This will be accessed using qualitative interviews and focus groups discussions. This is not a survey based study.

Patients reduce the amount of chemotherapy to avoid side effects

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

Participant uses P4 program before meeting with his clinician to discuss treatment options.

Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments.

Tailored online decision support system for prostate cancer treatment decision making

Seth Wolpin, RN, PhD

Donna L Berry, RN, PhD

The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.

Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.

About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.

Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

National Institute of Nursing Research (NINR)

University of Washington

Dana-Farber Cancer Institute

Director, The Phyllis F. Cantor Center

All Drugs and Chemicals

Immunomodulating Agents

Immunotherapy is currently a crucial cancer treatment option. Despite the development of new cancer treatment, patients and their family caregivers still experience complex psychological feelings and challenges about the effectiveness of immunotherapy, financial burden, and treatment related side effects which reflect the problems related to decision-making and the supportive care needs.

Patient Care Needs and the Decision-Making Experience of Patients With Cancer and Family Caregivers Regarding Immunotherapy: A Qualitative and Quantitative Mixed Methods Study

Patients' and family caregivers' supportive care needs will be measured by Supportive Care Needs Survey(SCNS) .It is a 5-Point Likert Scale,higher scores mean more care needs.

Patients' and family caregivers' physical and psychological symptoms will be measured by Physical and Psychological Symptom Scale.It use Numerical Rating Scale(VRS)0-10.It is a 11 Point Likert Scale(e. g. 0 is no pain; 10 is unbearable pain) .

Patients' and family caregivers' decision making process and conflict will be measured by CollaboRATE scale and SURE scale. CollaboRATE scale is a 10-Point Likert Scale (0-9), higher the score, the more effort you pay on this issues. SURE scale which base on Decisional Conflict Scale are 4 items,The question you agree that you can answer "YES" and got 1 point,if you not fit the description you have to answer "NO" and got 0 points,The lower the total score, the greater the decision conflict.

Patients' financial toxicity will be measured by COST-FACIT. It is a 5-Point Likert Scale (0-4),The higher the score for each question, the more often the problem occurs.

Patients' immunotherapy side effects will be measured by CTCAE.The severity is divided into 5 grades, the higher the grade, the higher the severity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Enhancing Shared Decision-Making in Breast Cancer	NCT03806738	Shared Decision...	Intervention-sp... Standard of Car...	18 Years -	University of Alabama at Birmingham
Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)	NCT03248258	Decision Making... De-escalation	Qualitative Int...	18 Years -	University of Alabama at Birmingham
Personal Patient Profile Prostate (P4) Randomized, Multisite Trial	NCT00692653	Prostate Cancer	P4	21 Years -	Dana-Farber Cancer Institute
Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)	NCT03248258	Decision Making... De-escalation	Qualitative Int...	18 Years -	University of Alabama at Birmingham
Enhancing Shared Decision-Making in Breast Cancer	NCT03806738	Shared Decision...	Intervention-sp... Standard of Car...	18 Years -	University of Alabama at Birmingham
Personal Patient Profile Prostate (P4) Randomized, Multisite Trial	NCT00692653	Prostate Cancer	P4	21 Years -	Dana-Farber Cancer Institute
Patient Care Needs and the Decision-Making Experience of Patients With Cancer and Family Caregivers Regarding Immunotherapy: A Qualitative and Quantitative Mixed Methods Study	NCT05740800	Supportive Care... Immunotherapy		20 Years - 100 Years	National Taiwan University Hospital

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