The ConnectedCancerCare Pilot Study (CCC)

NCT03618017 | Completed Results DMC

• 3 other identifiers: UMCC 2018.016K07CA201052HUM00115786
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-stage Breast Cancer; Breast Cancer Female; Survivorship; Cancer Survivors; Transitional Care

Keywords

Breast cancer; Survivors; Survivorship plan; Transitional cancer care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rating the Experience With the CCC Web-based, Survivorship Care Plan

  Follow-Up Survey: 3 months

• Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services

  3 months

• Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment

  3 months

• Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care

  3 months

• Percentage of Patients That Communicated With PCP About Provider Roles

  3 months

Study Arms (2)

CCC Website

EXPERIMENTAL

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.

Behavioral: CCC website

Static care plan

OTHER

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."

Behavioral: Static care plan

Interventions

CCC website BEHAVIORAL

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.

Also known as: ConnectedCancerCare

CCC Website

Static care plan BEHAVIORAL

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."

Static care plan

Eligibility Criteria

• Age: 21 Years - 84 Years
• Gender Eligibility Details: Women being treated at the University of Michigan Rogel Cancer Center for stage 0-2 breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Lauren Wallner, Ph.D.
• Organization: University of Michigan Rogel Cancer Center

lwallner@med.umich.edu

734-232-0788

Study Officials

• Lauren P Wallner, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 7, 2018
• Study Start: August 8, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)