Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Survivors who are enrolled at time of a follow-up visit and who will be offered the REASSURE intervention at the next 6 month visit (including the opportunity to replace a visit with feedback communication).

Survivors who are enrolled prior to a follow-up visit and who will be offered the REASSURE PRO assessment and feedback communication (but not provided the opportunity to replace a visit with feedback communication).

REASSURE utilizes remote patient-reported outcomes assessments to comprehensively assess symptoms, promotes practice change by providing feedback reports to oncologists and engaging primary care providers (PCPs) in survivorship care, and reduces the burden of follow-up by substituting an oncology visit for thriving survivors with reassurance messaging and encouragement to pursue preventive care.

REASSURE

Heather Neuman, MD, MS, FACS

This study tests a novel, risk-stratified approach for low risk breast cancer survivor follow-up care that reduces burden for survivors and their oncologists while simultaneously delivering more comprehensive care. The intervention is called Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals (REASSURE). 50 participants will be enrolled into 2 cohorts, 25 into cohort 1 who will experience the REASSURE intervention 6 months from enrollment and 25 into cohort 2 who will experience components of the REASSURE intervention at their next follow-up visit. Participants can expect to be on study for up to 9 months.

Current follow-up care for 3 million+ breast cancer survivors is both burdensome and fails to comprehensively address survivors' needs. Survivors and oncologists value these visits because visits reassure survivors about recurrence, and support oncologists' views about their responsibilities for managing ongoing therapy. However, early-stage survivors derive less benefit from follow-up, while incurring substantial financial burdens. Further, follow-up visit time restraints prevent addressing all topics prioritized by survivors or recommended as comprehensive survivorship care. Because most low-risk breast cancer survivors will never experience a recurrence, there is a critical need to develop a novel, risk-stratified approach to follow-up that reduces burden for survivors and their oncologists while simultaneously delivering more comprehensive care.

To address this gap, the team engaged stakeholders to develop an intervention for low-risk breast cancer survivors, called Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals (REASSURE). REASSURE maintains one annual in-person oncology visit, consistent with stakeholder preferences for oncology-based follow-up. REASSURE utilizes remote patient-reported outcomes assessments to comprehensively assess symptoms, promotes practice change by providing feedback reports to oncologists and engaging primary care providers (PCPs) in survivorship care, and reduces the burden of follow-up by substituting an oncology visit for thriving survivors with reassurance messaging and encouragement to pursue preventive care. The investigators have successfully pilot tested the PRO assessment and estimate that 25% of low-risk breast cancer survivors will have symptoms requiring a follow-up visit with medical oncology.

In this pilot feasibility study, the REASSURE intervention will be implemented into clinical care for the first time. Eligible survivors will be recruited and use mixed methods to accomplish four study objectives:

* Objective 1. Assess the feasibility of implementing REASSURE into clinical practice.
* Objective 2. Determine the number of survivorship symptoms/concerns that were addressed during the follow-up visit following clinician review of the REASSURE PRO assessment.
* Objective 3. Characterize the impact of REASSURE on healthcare utilization.
* Objective 4. Assess concordance between the referral recommendation generated from the PRO assessment and medical oncologist opinion.

Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals

Pilot Study of a Follow-up Intervention to Improve the Quality of Care for Low-Risk Breast Cancer Survivors

The Relationship between the survivor and oncologist (Therapeutic Alliance) will be measured using The Human Connection Scale, a 16-item questionnaire measured on a 4 point likert scale for a total possible range of scores from 16 - 64, where higher scores indicate increased therapeutic alliance.

The fear of cancer recurrence will be measured using the Impact of Event Scale, a 22-item self-report measure scored on a 5 point likert scale from 0 "not at all" to 4 "extremely", for a total possible range of scores from 0-88 where higher scores indicate increased fear of cancer recurrence.

The investigator's goal is a 50% recruitment rate of eligible patients

The investigator's will summarize the number of domains where survivors reported symptoms/concerns and compare that to the number of domains that were addressed, either by the PRO generated recommendation or during the follow-up visit.

The investigator's goal is to have 33% of REASSURE cohort 1 replace a follow-up visit with medical oncology with feedback communication and REASSURE cohort 2 to be eligible to replace a follow-up visit (if the full intervention had been implemented).

The investigator's goal is to have 75% of referral recommendations be concordant with medical oncology opinion.

Participants will be asked to answer yes or no to the following question: "Would you recommend this approach to follow-up to other survivors?"

Scored on a 5 point likert scale where 1 = very dissatisfied; 2 = dissatisfied; 3 = neutral; 4 = satisfied; 5 = very satisfied. Higher scores indicated increased satisfaction, mean score between 1-5 will be reported.

This is an 11 item scale, measured on a 4-point Likert scale from 0 to 3 where lower scores indicate more knowledge. Mean score between 0-3 will be reported.

This is a 5 item scale, measured on a 10-point Likert scale where higher scores indicate increased preparedness. Mean score between 1-10 will be reported.

University of Wisconsin, Madison

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Fibrinolytic Agents

Anti-Infective Agents

Docetaxel

Fluorouracil

Cyclophosphamide

Epirubicin

Plasminogen

Plasminogen Inactivators

Taxane

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

3 courses FEC q3weeks followed by 3 courses Docetaxel q3weeks

Arm A 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q3weeks followed by Docetaxel 100 mg/m² q3weeks

Arm B 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q6weeks

5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel

Christoph Thomssen, MD

Nadia Harbeck, MD

In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The identification of this subgroup can be based either on clinical and pathological or on tumour-biological criteria. Due to their high prognostic impact, the tumour-biological invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1) are potential candidates to effectively assess the risk of relapse in node-negative breast cancer. This study is aimed to compare the risk assessment by the traditional clinico-pathological factors and by tumour-biological factors. The second study question refers to the comparison between an adjuvant combination treatment with FE100C\*6 and a sequential treatment with FE100C\*3 and Docetaxel\*3.

1. To compare FEC\*6 with FEC\*3 followed by DOC\*3 with regard to:

   * the primary endpoint of the study: Disease-Free Survival (DFS)
   * the secondary endpoints: Overall Survival (OS), compliance, and toxicity of chemotherapy in each patient group
2. To compare patients with low risk according to clinico-pathological versus those according to biological risk criteria with regard to:

   * the proportion of low risk versus high risk patients
   * DFS
   * OS (secondary endpoint)

6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients

Randomized Multicenter Study Comparing 6xFEC With 3xFEC-3xDoc in High-risk Node-negative Patients With Operable Breast Cancer: Comparison of Efficacy and Evaluation of Clinico-pathological and Biochemical Markers as Risk Selection Criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals	NCT05047575	Breast Cancer	REASSURE	18 Years - 95 Years	University of Wisconsin, Madison
6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients	NCT01222052	Breast Cancer	5-Fluorouracil,...	18 Years - 70 Years	Martin-Luther-Universität Halle-Wittenberg
Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals	NCT05047575	Breast Cancer	REASSURE	18 Years - 95 Years	University of Wisconsin, Madison

Spots Global Cancer Trial Database for low risk breast cancer