- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03618017
The ConnectedCancerCare Pilot Study (CCC) (CCC)
October 12, 2020 updated by: University of Michigan Rogel Cancer Center
Patient-Centered, Team-Based Continuing Care After Breast Cancer Treatment: The ConnectedCancerCare Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- The University of Michigan Rogel Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 84 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
ConnectedCancerCare (CCC) is a web-based guide to support survivorship care for women who have been treated for early-stage (stages 0-II) breast cancer.
It encourages patients to utilize team-based care by oncologists and primary care physicians and provides them with the information on cancer surveillance, screenings and preventive healthcare during survivorship.
Other Names:
|
Other: 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."
|
The control is a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as "standard of care."
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Breast Cancer Patients Successfully Recruited to Participate in the Study
Time Frame: 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.
|
At baseline survey
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rating the Experience With the CCC Web-based, Survivorship Care Plan
Time Frame: 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.
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Follow-Up Survey: 3 months
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Time Frame: 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.
|
3 months
|
Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment
Time Frame: 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).
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3 months
|
Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care
Time Frame: 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.
|
3 months
|
Percentage of Patients That Communicated With PCP About Provider Roles
Time Frame: 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).
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3 months
|
Knowledge About Team-based Survivorship Care
Time Frame: 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.
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lauren P Wallner, Ph.D, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2018
Primary Completion (Actual)
August 30, 2019
Study Completion (Actual)
August 30, 2019
Study Registration Dates
First Submitted
July 13, 2018
First Submitted That Met QC Criteria
July 31, 2018
First Posted (Actual)
August 7, 2018
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
October 12, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCC 2018.016
- K07CA201052 (U.S. NIH Grant/Contract)
- HUM00115786 (Other Identifier: University of Michigan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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