Skip to content

The ConnectedCancerCare Pilot Study (CCC)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03618017
Acronym
CCC
Enrollment
66
Registered
2018-08-07
Start date
2018-08-08
Completion date
2019-08-30
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Breast cancer, Survivors, Survivorship plan, Transitional cancer care

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.

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.

Interventions

BEHAVIORALCCC 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.

BEHAVIORALStatic 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 84 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Breast Cancer Patients Successfully Recruited to Participate in the StudyAt baseline surveyWe 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

MeasureTime frameDescription
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services3 monthsAn 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.
Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment3 monthsThe 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).
Rating the Experience With the CCC Web-based, Survivorship Care PlanFollow-Up Survey: 3 monthsAcceptability 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.
Percentage of Patients That Communicated With PCP About Provider Roles3 monthsCommunication 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).
Knowledge About Team-based Survivorship Care3 monthsKnowledge 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.
Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care3 monthsA 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.

Countries

United States

Participant flow

Pre-assignment details

160 eligible women were invited to participate; 66 women enrolled (completed the baseline survey and were randomized).

Participants by arm

ArmCount
Static Care Plan
The control arm will receive a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as standard of care.
33
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.
33
Total66

Baseline characteristics

CharacteristicTotalStatic Care PlanCCC Website
Age, Continuous56.0 years
STANDARD_DEVIATION 11.2
54.1 years
STANDARD_DEVIATION 11.4
57.8 years
STANDARD_DEVIATION 10.8
Breast Cancer Stage at Diagnosis
Stage 0
5 Participants3 Participants2 Participants
Breast Cancer Stage at Diagnosis
Stage 1
29 Participants14 Participants15 Participants
Breast Cancer Stage at Diagnosis
Stage 2
21 Participants14 Participants7 Participants
Education
College graduate or more
43 Participants23 Participants20 Participants
Education
High school/some college
23 Participants10 Participants13 Participants
Employment
Employed
34 Participants17 Participants17 Participants
Employment
Other not employed
14 Participants6 Participants8 Participants
Employment
Retired
18 Participants10 Participants8 Participants
Had a primary care provider at enrollment
No
4 Participants2 Participants2 Participants
Had a primary care provider at enrollment
Yes
62 Participants31 Participants31 Participants
Insurance
Medicaid/Other government
4 Participants3 Participants1 Participants
Insurance
Medicare
18 Participants10 Participants8 Participants
Insurance
Private
44 Participants20 Participants24 Participants
Number of Comorbidities
0
30 Participants15 Participants15 Participants
Number of Comorbidities
1
26 Participants14 Participants12 Participants
Number of Comorbidities
2+
10 Participants4 Participants6 Participants
On endocrine therapy
No
9 Participants7 Participants2 Participants
On endocrine therapy
Yes
57 Participants26 Participants31 Participants
Primary Surgical Treatment
Bilateral mastectomy
14 Participants8 Participants6 Participants
Primary Surgical Treatment
Lumpectomy
37 Participants20 Participants17 Participants
Primary Surgical Treatment
Unilateral mastectomy
15 Participants5 Participants10 Participants
Race/Ethnicity, Customized
Asian
4 Participants3 Participants1 Participants
Race/Ethnicity, Customized
Black
2 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Other
2 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White
56 Participants27 Participants29 Participants
Received Chemotherapy
No
36 Participants17 Participants19 Participants
Received Chemotherapy
Yes
30 Participants16 Participants14 Participants
Received radiation
No
20 Participants9 Participants11 Participants
Received radiation
Yes
46 Participants24 Participants22 Participants
Sex: Female, Male
Female
66 Participants33 Participants33 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 33
other
Total, other adverse events
0 / 330 / 33
serious
Total, serious adverse events
0 / 330 / 33

Outcome results

Primary

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.

Time frame: At baseline survey

Population: Number of eligible women invited to participate

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Recruitment PopulationNumber of Breast Cancer Patients Successfully Recruited to Participate in the Study66 Participants
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Recruitment PopulationKnowledge About Team-based Survivorship Care3.4 score on a scaleStandard Deviation 0.9
Intervention: CCC WebsiteKnowledge About Team-based Survivorship Care3.7 score on a scaleStandard Deviation 0.6
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Recruitment PopulationPatient-Reported Satisfaction With Oncologist/PCP Coordination of Care3.1 score on a scaleStandard Deviation 1.2
Intervention: CCC WebsitePatient-Reported Satisfaction With Oncologist/PCP Coordination of Care3.7 score on a scaleStandard Deviation 1
Secondary

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.

Time frame: 3 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Recruitment PopulationPercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesSurveillance (mammogram)0 Participants
Recruitment PopulationPercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesScreening for second primary cancers5 Participants
Recruitment PopulationPercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesGeneral preventive care23 Participants
Recruitment PopulationPercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesComorbidity management24 Participants
Recruitment PopulationPercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesPhysical effects2 Participants
Recruitment PopulationPercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesPsychological effects15 Participants
Recruitment PopulationPercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesReassurance about recurrence risk1 Participants
Recruitment PopulationPercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesEndocrine therapy management13 Participants
Intervention: CCC WebsitePercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesEndocrine therapy management15 Participants
Intervention: CCC WebsitePercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesSurveillance (mammogram)3 Participants
Intervention: CCC WebsitePercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesPhysical effects3 Participants
Intervention: CCC WebsitePercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesScreening for second primary cancers14 Participants
Intervention: CCC WebsitePercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesReassurance about recurrence risk1 Participants
Intervention: CCC WebsitePercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesGeneral preventive care25 Participants
Intervention: CCC WebsitePercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesPsychological effects20 Participants
Intervention: CCC WebsitePercentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care ServicesComorbidity management24 Participants
Secondary

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).

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Recruitment PopulationPercentage of Patients Scheduling a Primary Care Physician (PCP) Appointment11 Participants
Intervention: CCC WebsitePercentage of Patients Scheduling a Primary Care Physician (PCP) Appointment18 Participants
Secondary

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).

Time frame: 3 months

Population: Participants who saw a PCP after completing the baseline survey are included in the analysis population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Recruitment PopulationPercentage of Patients That Communicated With PCP About Provider Roles2 Participants
Intervention: CCC WebsitePercentage of Patients That Communicated With PCP About Provider Roles12 Participants
Secondary

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.

Time frame: Follow-Up Survey: 3 months

Population: Intervention arm only; participants who completed the follow-up survey at 3 months post-randomization

ArmMeasureValue (MEAN)Dispersion
Recruitment PopulationRating the Experience With the CCC Web-based, Survivorship Care Plan4.4 score on a scaleStandard Deviation 2

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026