Clinical trial NCT03618017: The ConnectedCancerCare Pilot Study (CCC)
Official title: Patient-Centered, Team-Based Continuing Care After Breast Cancer Treatment: The ConnectedCancerCare Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early-stage Breast Cancer
Breast Cancer Female
Survivorship
Cancer Survivors
Transitional Care
Keywords: Breast cancer
Survivors
Survivorship plan
Transitional cancer care
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-08-07
Enrollment: 66
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized control pilot trial of a web-based, personalized navigation tool to support the continuing and team-based care of early-stage breast cancer patients who have completed their primary cancer treatment. Patients will be randomized to either the intervention (n=30), a personalized website that guides team-based, survivorship care or to the control (n=30), an static online survivorship care plan.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is an NCI-funded, randomized control pilot trial to evaluate: (1) the feasibility and acceptability of a web-based, personalized navigation tool (ConnectedCancerCare) and (2) explore whether the tool improves delivery of team-based survivorship care for women who have recently finished primary breast cancer treatment.

Detailed description: This study is a randomized control pilot trial involving 60 women newly diagnosed with early-stage breast cancer who are finishing primary treatment. Participants will be randomized either to the intervention arm (CCC website that provides information on team-based follow-up care for both cancer surveillance and preventive care) or the control arm (static online survivorship care plan template, adapted from the ASCO breast cancer survivorship template). The feasibility and acceptability of the tool and correlations with patient-reported outcomes will be assessed 3 months following the completion of a baseline survey via an online follow-up survey.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with early Stage (0-IIB) breast cancer
* Must be a patient of a University of Michigan Breast Cancer Oncologist
* Must be completing primary cancer treatment and transitioning into survivorship
* Must be able to speak, read and write in English
* Must have access and the ability to use the internet

Exclusion Criteria:

* Diagnosed with stage III or IV breast cancer
* Unable to speak, read, and write in English

Primary outcomes:
measure: Number of Breast Cancer Patients Successfully Recruited to Participate in the Study
timeFrame: At baseline survey
Secondary outcomes:
measure: Rating the Experience With the CCC Web-based, Survivorship Care Plan
timeFrame: Follow-Up Survey: 3 months
measure: Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
timeFrame: 3 months
measure: Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment
timeFrame: 3 months
measure: Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care
timeFrame: 3 months
measure: Percentage of Patients That Communicated With PCP About Provider Roles
timeFrame: 3 months
measure: Knowledge About Team-based Survivorship Care
timeFrame: 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lauren P Wallner, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: