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The ConnectedCancerCare Pilot Study (CCC)

University of Michigan Rogel Cancer Center logo

University of Michigan Rogel Cancer Center

Status

Completed

Conditions

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

Treatments

Behavioral: CCC website
Behavioral: Static care plan

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03618017
UMCC 2018.016
HUM00115786 (Other Identifier)
K07CA201052 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

Female

Ages

21 to 84 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

66 participants in 2 patient groups

CCC Website
Experimental group
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.
Treatment:
Behavioral: CCC website
Static care plan
Other group
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."
Treatment:
Behavioral: Static care plan

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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