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The ConnectedCancerCare Pilot Study (CCC)

NCT ID: NCT03618017

Last Updated: 2020-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-08

Study Completion Date

2019-08-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

CCC website

Intervention Type 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.

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."

Group Type OTHER

Static care plan

Intervention Type 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."

Interventions

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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.

Intervention Type BEHAVIORAL

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."

Intervention Type BEHAVIORAL

Other Intervention Names

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ConnectedCancerCare

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

84 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren P Wallner, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K07CA201052

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00115786

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2018.016

Identifier Type: -

Identifier Source: org_study_id