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Early-stage Breast CancerCCCNCT03618017

The ConnectedCancerCare Pilot Study (CCC)

A study testing CCC website and Static care plan in people with Early-stage Breast Cancer and Breast Cancer Female, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 to 84 years, women only
What is being tested?
CCC website and Static care plan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
8 Aug 2018to 30 Aug 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 84 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
CCC website, Static care plan
Keywords
Breast cancer, Survivors, Survivorship plan, Transitional cancer care
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCC websiteBehavioural

    Also called ConnectedCancerCare

    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 planBehavioural

    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."

Study groups in NCT03618017
Study groupRoleWhat they receive
CCC WebsiteExperimentalThe 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.
Receives: Behavioral: CCC website
Static care planOtherThe 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."
Receives: Behavioral: Static care plan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline survey

Secondary outcomes (6)

  1. 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.

    Measured: Follow-Up Survey: 3 months

  2. 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.

    Measured: 3 months

  3. 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).

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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).

    Measured: 3 months

  6. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2018
  2. Study start8 Aug 2018
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03618017
Sponsor's protocol ID
UMCC 2018.016
Other IDs
K07CA201052, HUM00115786
Acronym
CCC
Status last verified
Oct 2020
First submitted
13 Jul 2018
Last updated
4 Nov 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CCC website and Static care plan in people with Early-stage Breast Cancer and Breast Cancer Female, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Breast Cancer Patients Successfully Recruited to Participate in the Study (time frame: At baseline survey). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03618017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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