The ConnectedCancerCare Pilot Study (CCC)

Not Applicable

Completed

Conditions: Cancer Survivors
Survivorship
Early-stage Breast Cancer
Breast Cancer Female
Transitional Care

Interventions: Behavioral: Static care plan
Behavioral: CCC website

Registration Number: NCT03618017

Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 66

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Static care plan	Static care plan	The control arm will receive is a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as "standard of care."
CCC Website	CCC website	The intervention, ConnectedCancerCare (CCC) Website is a personalized, navigation tool that is tailored to patients' preferences for provider roles in follow-up care, their satisfaction with their current primary care provider, and their worry about cancer recurrence. It involves a personalized, patient-facing website which includes a baseline survey, tailored educational modules, and a guide for their survivorship care, as well as a text or email based reminder system. The intervention also includes a provider-facing summary document, which will be faxed to both the oncology and primary care teams.

Primary Outcome Measures

Name	Time	Method
Number of Breast Cancer Patients Successfully Recruited to Participate in the Study	At baseline survey	We anticipate a response rate of 80% enrollment (n=60). We will assess the number of patients successfully recruited who enroll and complete the baseline survey.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients That Communicated With PCP About Provider Roles	3 months	Communication with PCP about provider roles was measured using an item adapted to the patient perspective from a prior study of providers' views about shared cancer care roles. Patients were asked if they communicated in the past 3 months with their PCP about who will manage specific aspects of their survivorship care (yes/no).
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services	3 months	An 8 item list of continuing care services adapted from the CanSORT Provider Roles Scale (iCanCare Study) is used to assess participants' preferences for seeing their Oncologist or PCP.
Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care	3 months	A 5-point scale will be used to ask patients to rate their satisfaction with the coordination of care provided by their Oncologist and PCP. The rating scale will range from a value of 1 ('not at all') to a value of 5 ('extremely satisfied'), with a higher numeric value representing greater satisfaction with coordination of care. The mean satisfaction scores will be compared between the intervention and control arms.
Rating the Experience With the CCC Web-based, Survivorship Care Plan	Follow-Up Survey: 3 months	Acceptability and usability assessed by the following 6 key factors: 1. Ease of use; 2. Helpful during the transition to survivorship; 3. Helpful in terms of planning when to see my PCP and when to see my Oncologist; 4."Would recommend CCC to other patients"; 5. Length of time it took to go through the website; 6. Amount of information on the website. Each of the 6 factors will be assessed using a 5-point (1-5) Likert scale with higher scores (3, 4, 5) representing better acceptance and usability of the CCC website. Based on prior work, a cut off of 50% or more reporting a score of 3 or higher will be used to measure acceptance within each domain. The average of each participant's responses to the 6 items will result in one score per participant, on a scale of 1 - 5. A single summary score of acceptability across all participants will be determined by averaging the individual scores. On a scale of 1-5, a score of 3 or higher indicates acceptability to the majority of participants.
Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment	3 months	The percentage of patients who have scheduled a follow-up visit with their PCP after viewing the CCC web tool (intervention arm) or after receiving the static survivorship care plan (control arm).
Knowledge About Team-based Survivorship Care	3 months	Knowledge about team-based survivorship care was measured utilizing an 8-item scale adapted from the Perceived Primary Care Delivery of Survivorship Care Scale. It includes items specific to patients' knowledge of PCPs roles in team-based care delivery, (e.g. second cancer screening, symptom management). The responses were rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The responses to the 8 items were then averaged to create a mean knowledge summary score for each participant, ranging from 1 to 5, with higher values representing greater knowledge about team-based survivorship care.