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Completed

NCT Number: NCT03618017

The ConnectedCancerCare Pilot Study (CCC)

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.

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Key information

Age range

21 year–84 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ConnectedCancerCare

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."

Primary outcomes

  1. Number of Breast Cancer Patients Successfully Recruited to Participate in the Study

    Time frame: At baseline survey

    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.

Secondary outcomes

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

    Time frame: Follow-Up Survey: 3 months

    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.

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

    Time frame: 3 months

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

    Time frame: 3 months

    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).

  4. Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care

    Time frame: 3 months

    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.

  5. Percentage of Patients That Communicated With PCP About Provider Roles

    Time frame: 3 months

    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).

  6. Knowledge About Team-based Survivorship Care

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: CCC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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