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Completed

NCT Number: NCT05047575

Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–95 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • history of stage I, ER and/or PR positive, her2neu negative breast cancer
  • 12-36 months from diagnosis at the time of the survey assessment (for both REASSURE cohorts 1 and 2). For REASSURE cohort 1, this will translate into being 6-18 months from diagnosis at the time they are approached for the study.
  • receiving follow-up for their breast cancer with a University of Wisconsin (UW) Breast Center medical oncologist participating in the REASSURE pilot study
  • ability to complete the PRO assessment online
  • English speaker

Exclusion criteria

  • receipt of chemotherapy
  • non-English speakers
  • pregnancy
  • cancer recurrence (local, regional or distant) since the initial diagnosis

Treatment and study plan

REASSURE

Other

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.

Other names: Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals

Primary outcomes

  1. Feasibility: Number of Eligible Participants Enrolled

    Time frame: up to 6 months

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

  2. Number of survivorship symptoms/concerns that were addressed during the follow-up visit following clinician review of the REASSURE PRO assessment

    Time frame: up to 9 months

    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.

  3. Number of Participants who Replace or are Eligible to Replace a Medical Oncology Follow-Up visit with Feedback Communication

    Time frame: up to 1 year

    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).

  4. Number of PRO-generated Referral Recommendations that are Concordant with Medical Oncology Opinion

    Time frame: up to 6 months

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

Secondary outcomes

  1. Percent of Survivors Who Would Recommend this Approach to other survivors

    Time frame: up to 9 months

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

  2. Number of Participants Whose Concerns Were Addressed During the Preceding Visit

    Time frame: up to 6 months

  3. Satisfaction with survivorship information measured with the Satisfaction with Information and Care Scale

    Time frame: up to 6 months

    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.

  4. Knowledge about survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale

    Time frame: up to 6 months

    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.

  5. Preparedness for survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale

    Time frame: up to 6 months

    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.

Other outcomes

  1. The Human Connection (THC) Scale Score

    Time frame: up to 9 months

    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.

  2. Impact of Event Scale Score

    Time frame: up to 9 months

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Acronym: REASSURE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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