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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months

regular follow-up schedule according to the guideline, 10-13 visits during 5 years

In the intervention group, the follow-up schedule will be limited to four follow-up visits at 3, 12, 24 and 36 months, under the specific condition that patients have easy and prompt access to care (specialised nurse of gynaecologist) if symptoms or questions occur. The content of the follow-up visits will be similar for both groups.

Reduced follow-up schedule

Lonneke van de Poll-Franse, PhD

Roy Kruitwagen, PhD

Carien Creutzberg, PhD

Nicole Ezendam, PhD

Background: It has often been hypothesized that the frequency of follow-up for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking.

Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline.

Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient inclusion will take two years (if 60% of the patients participate).

Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.

Secondary: health care use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, survival

Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant radiotherapy is not indicated

Statistics: linear regression analyses to assess differences in patient satisfaction with follow-up care between intervention and control group adjusted for potential pre-defined confounders.

Expected results: Patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower health care use and costs than patients in the control arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced schedule is expected to save 144.000 per year in the Netherlands.

ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?

ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? Randomized Controlled Trial to Evaluate Patient Satisfaction and Cost-effectiveness of a Reduced Follow-up Schedule

After ending the study and analysis of the data, data becomes available for use by other researchers via PROFILES registry, according to the their terms

assessed with the PSQIII questionnaire; analysed with a repeated mixed model as one overall outcome over all time points

Cost-effectiveness from the health care perspective using the EQ-5D

health care use is assessed from hospital charges, primary care physician and self-report; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points

assessed with structured interviews/questionnaires

In this study we will descriptively look at time till recurrence

Dutch Cancer Society

Maastricht University Medical Center

Leiden University Medical Center

Comprehensive Cancer Centre The Netherlands

REASSURE is comprised of three components that are intended to be integrated into survivorship care at each follow-up visit: 1) An online patient-reported outcome (PRO) assessment to comprehensively evaluate survivors' symptoms and concerns; 2) A tailored follow-up recommendation based on pre-established thresholds for reported symptoms and concerns. Survivors who report symptoms or concerns have a follow-up visit to discuss findings whereas survivors without symptoms or concerns will avoid a follow-up visit; and 3) Online survivorship messaging sent after the visit, which includes reassurance about the low recurrence risk, an overview of what to expect from follow-up, and steps survivors can take to reduce cancer risk.

Cancer Connect

Heather Neuman

This study tests a novel intervention designed to optimize needed survivorship care for low-risk breast cancer survivors while reducing burdensome care with limited health benefits. This study examines whether the intervention, titled REASSURE, improves survivors' preparedness for survivorship. Up to 110 participants will be on study for up to 18 months.

The investigators plan a single site prospective, randomized, trial that will compare the effect of REASSURE on survivor preparedness against usual care. Survivors will be identified from breast oncology clinics within UW Health.

REASSURE is comprised of three components: 1) the REASSURE PRO assessment, which assesses survivors' symptoms and/or concerns, 2) a recommendation for or against a follow-up visit based on survivors reported symptoms /concerns using pre-established thresholds, and 3) REASSURE survivorship messaging.

* Primary Objective

  * Compare survivors' preparedness for survivorship with REASSURE versus usual care.
* Secondary Objectives

  * Determine the acceptability of REASSURE for survivors living in rural and non-rural areas.
  * Assess changes in survivor reported symptoms and number of follow-up visits with REASSURE versus usual care.

This is a randomized, trial of REASSURE vs usual care within UW Health oncology clinics

Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer

Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin

Receipt of recommended cancer care over 18-months (chart review, yes/no)

Impact of Event Scale (measure of cancer-related anxiety) is a 15-item survey scored on a 5 point likert scale for a total possible range of scores from 15-75 where higher scores indicate higher anxiety.

Satisfaction with Information is measured using a 14-item survey scored on a 5 point likert scale for a total possible range of scores from 14-70 where higher scores indicate increased satisfaction with information.

Human Connection Scale (measure of therapeutic alliance with providers) is a 10-item survey measured on a 5 point likert scale for a total possible range of scores from 10 to 50 where higher scores indicate higher connection with provider.

Quality of follow-up care using the question: "How would you rate the quality of follow-up care you received in the past 2 years?" This scored from 1 (poor) to 5 (excellent).

Healthcare utilization is measured via chart review, and includes use of ancillary services, visits with primary care, visits to urgent care/emergency room.

Healthcare utilization is measured via chart review, and includes number of my-chart visits and documented phone calls during 18 month study period.

Survivors' preparedness for survivorship will be assessed using Part 1 of the Preparing for Life as a (New) Survivor (PLANS) scale. This is an 11-item survey scored on a 4 point likert scale for a total possible range of score from 11 - 44 where higher scores indicate increased preparedness.

Survivors' confidence about follow-up will be assessed using Part 2 of the Preparing for Life as a (New) Survivor (PLANS) scale. This is a 5-item survey scored on a 10 point likert scale for a total possible range of score from 5 - 50 where higher scores indicate increased confidence.

REASSURE will be considered acceptable if ≥80% of survivors in the REASSURE arm respond "yes" to, "Would you recommend this approach to follow-up to other survivors?".

The number of threshold-level symptoms reported on the Patient Reported Outcome (PRO) assessment at each follow-up time point will be reported. This is based on the investigators' previously established thresholds of symptoms or concerns that warrant a visit. Some symptoms were "hard stops", meaning any reported symptom triggered a visit, other symptoms triggered a visit based on severity or level of interference.

The number of follow-up visits over the 18-month follow-up period will be counted. All follow-up visits that occur in medical oncology, radiation oncology, surgery, and survivorship clinics, including both physician and advanced practice provider visits will be counted.

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
Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals	NCT05047575	Breast Cancer	REASSURE	18 Years - 95 Years	University of Wisconsin, Madison
ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?	NCT02413606	Endometrial Can...	Reduced follow-...	-	Comprehensive Cancer Centre The Netherlands
Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer	NCT05609435	Breast Cancer	REASSURE	18 Years - 95 Years	University of Wisconsin, Madison
Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer	NCT05609435	Breast Cancer	REASSURE	18 Years - 95 Years	University of Wisconsin, Madison

Spots Global Cancer Trial Database for follow up care