An interventional study of REASSURE in Breast Cancer, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2022-09-09.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Supportive care
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:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: REASSURE
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).
Other: REASSURE
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.
Also known as: Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals
Feasibility: Number of Eligible Participants Enrolled
The investigator's goal is a 50% recruitment rate of eligible patients
Time frame: up to 6 months
Number of survivorship symptoms/concerns that were addressed during the follow-up visit following clinician review of the REASSURE PRO assessment
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.
Time frame: up to 9 months
Number of Participants who Replace or are Eligible to Replace a Medical Oncology Follow-Up visit with Feedback Communication
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).
Time frame: up to 1 year
Number of PRO-generated Referral Recommendations that are Concordant with Medical Oncology Opinion
The investigator's goal is to have 75% of referral recommendations be concordant with medical oncology opinion.
Time frame: up to 6 months
Percent of Survivors Who Would Recommend this Approach to other survivors
Participants will be asked to answer yes or no to the following question: "Would you recommend this approach to follow-up to other survivors?"
Time frame: up to 9 months
Number of Participants Whose Concerns Were Addressed During the Preceding Visit
Time frame: up to 6 months
Satisfaction with survivorship information measured with the Satisfaction with Information and Care Scale
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.
Time frame: up to 6 months
Knowledge about survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale
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.
Time frame: up to 6 months
Preparedness for survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale
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.
Time frame: up to 6 months
The Human Connection (THC) Scale Score
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.
Time frame: up to 9 months
Impact of Event Scale Score
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.
Time frame: up to 9 months
Plan to share: No
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University of Wisconsin, Madison