The ConnectedCancerCare Pilot Study (CCC)

Breast Cancer Female Clinical Trial

— CCC  

Official title:

Patient-Centered, Team-Based Continuing Care After Breast Cancer Treatment: The ConnectedCancerCare Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618017
• Other study ID #: UMCC 2018.016
• Secondary ID: K07CA201052HUM00
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: October 2020
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Cancer Survivors
• Early-stage Breast Cancer
• Survivorship
• Transitional Care

Intervention

Behavioral:
• CCC website
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.
• Static care plan
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."

Locations

Country	Name	City	State
United States	The University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline survey
Secondary	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.	Follow-Up Survey: 3 months
Secondary	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.	3 months
Secondary	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).	3 months
Secondary	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.	3 months
Secondary	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).	3 months
Secondary	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.	3 months