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The ConnectedCancerCare Pilot Study (CCC) (CCC)

Primary Purpose

Early-stage Breast Cancer, Breast Cancer Female, Survivorship

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CCC website
Static care plan
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Early-stage Breast Cancer focused on measuring Breast cancer, Survivors, Survivorship plan, Transitional cancer care

Eligibility Criteria

21 Years - 84 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Michigan Rogel Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CCC Website

Static care plan

Arm Description

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.

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."

Outcomes

Primary Outcome Measures

Number of Breast Cancer Patients Successfully Recruited to Participate in the Study
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

Rating the Experience With the CCC Web-based, Survivorship Care Plan
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 Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
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.
Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment
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).
Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care
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.
Percentage of Patients That Communicated With PCP About Provider Roles
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).
Knowledge About Team-based Survivorship Care
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.

Full Information

First Posted
July 13, 2018
Last Updated
October 12, 2020
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03618017
Brief Title
The ConnectedCancerCare Pilot Study (CCC)
Acronym
CCC
Official Title
Patient-Centered, Team-Based Continuing Care After Breast Cancer Treatment: The ConnectedCancerCare Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-stage Breast Cancer, Breast Cancer Female, Survivorship, Cancer Survivors, Transitional Care
Keywords
Breast cancer, Survivors, Survivorship plan, Transitional cancer care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants will be randomized to the intervention (website) or control (informational template) after completing an online questionnaire; they will not be informed of which arm of the study they are participating. The allocation of participants will be masked for the investigator and outcomes assessor.
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCC Website
Arm Type
Experimental
Arm Description
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.
Arm Title
Static care plan
Arm Type
Other
Arm Description
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."
Intervention Type
Behavioral
Intervention Name(s)
CCC website
Other Intervention Name(s)
ConnectedCancerCare
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Static care plan
Intervention Description
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."
Primary Outcome Measure Information:
Title
Number of Breast Cancer Patients Successfully Recruited to Participate in the Study
Description
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.
Time Frame
At baseline survey
Secondary Outcome Measure Information:
Title
Rating the Experience With the CCC Web-based, Survivorship Care Plan
Description
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.
Time Frame
Follow-Up Survey: 3 months
Title
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Description
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.
Time Frame
3 months
Title
Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment
Description
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).
Time Frame
3 months
Title
Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care
Description
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.
Time Frame
3 months
Title
Percentage of Patients That Communicated With PCP About Provider Roles
Description
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).
Time Frame
3 months
Title
Knowledge About Team-based Survivorship Care
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women being treated at the University of Michigan Rogel Cancer Center for stage 0-2 breast cancer.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren P Wallner, Ph.D
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The ConnectedCancerCare Pilot Study (CCC)

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