Trial Outcomes & Findings for The ConnectedCancerCare Pilot Study (CCC) (NCT NCT03618017)
NCT ID: NCT03618017
Last Updated: 2020-11-04
Results Overview
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.
COMPLETED
NA
66 participants
At baseline survey
2020-11-04
Participant Flow
160 eligible women were invited to participate; 66 women enrolled (completed the baseline survey and were randomized).
Participant milestones
| Measure |
Control: 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."
|
Intervention: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
11 participants did not self-report this data.
Baseline characteristics by cohort
| Measure |
Static Care Plan
n=33 Participants
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."
|
CCC Website
n=33 Participants
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.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Breast Cancer Stage at Diagnosis
Stage 0
|
3 Participants
n=31 Participants • 11 participants did not self-report this data.
|
2 Participants
n=24 Participants • 11 participants did not self-report this data.
|
5 Participants
n=55 Participants • 11 participants did not self-report this data.
|
|
Breast Cancer Stage at Diagnosis
Stage 1
|
14 Participants
n=31 Participants • 11 participants did not self-report this data.
|
15 Participants
n=24 Participants • 11 participants did not self-report this data.
|
29 Participants
n=55 Participants • 11 participants did not self-report this data.
|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 11.4 • n=33 Participants
|
57.8 years
STANDARD_DEVIATION 10.8 • n=33 Participants
|
56.0 years
STANDARD_DEVIATION 11.2 • n=66 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=33 Participants
|
33 Participants
n=33 Participants
|
66 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=33 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=66 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=33 Participants
|
29 Participants
n=33 Participants
|
56 Participants
n=66 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=33 Participants
|
1 Participants
n=33 Participants
|
2 Participants
n=66 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=33 Participants
|
1 Participants
n=33 Participants
|
2 Participants
n=66 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=33 Participants
|
1 Participants
n=33 Participants
|
4 Participants
n=66 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=33 Participants
|
1 Participants
n=33 Participants
|
2 Participants
n=66 Participants
|
|
Education
High school/some college
|
10 Participants
n=33 Participants
|
13 Participants
n=33 Participants
|
23 Participants
n=66 Participants
|
|
Education
College graduate or more
|
23 Participants
n=33 Participants
|
20 Participants
n=33 Participants
|
43 Participants
n=66 Participants
|
|
Insurance
Medicare
|
10 Participants
n=33 Participants
|
8 Participants
n=33 Participants
|
18 Participants
n=66 Participants
|
|
Insurance
Medicaid/Other government
|
3 Participants
n=33 Participants
|
1 Participants
n=33 Participants
|
4 Participants
n=66 Participants
|
|
Insurance
Private
|
20 Participants
n=33 Participants
|
24 Participants
n=33 Participants
|
44 Participants
n=66 Participants
|
|
Employment
Employed
|
17 Participants
n=33 Participants
|
17 Participants
n=33 Participants
|
34 Participants
n=66 Participants
|
|
Employment
Retired
|
10 Participants
n=33 Participants
|
8 Participants
n=33 Participants
|
18 Participants
n=66 Participants
|
|
Employment
Other not employed
|
6 Participants
n=33 Participants
|
8 Participants
n=33 Participants
|
14 Participants
n=66 Participants
|
|
Breast Cancer Stage at Diagnosis
Stage 2
|
14 Participants
n=31 Participants • 11 participants did not self-report this data.
|
7 Participants
n=24 Participants • 11 participants did not self-report this data.
|
21 Participants
n=55 Participants • 11 participants did not self-report this data.
|
|
Primary Surgical Treatment
Lumpectomy
|
20 Participants
n=33 Participants
|
17 Participants
n=33 Participants
|
37 Participants
n=66 Participants
|
|
Primary Surgical Treatment
Unilateral mastectomy
|
5 Participants
n=33 Participants
|
10 Participants
n=33 Participants
|
15 Participants
n=66 Participants
|
|
Primary Surgical Treatment
Bilateral mastectomy
|
8 Participants
n=33 Participants
|
6 Participants
n=33 Participants
|
14 Participants
n=66 Participants
|
|
Received radiation
No
|
9 Participants
n=33 Participants
|
11 Participants
n=33 Participants
|
20 Participants
n=66 Participants
|
|
Received radiation
Yes
|
24 Participants
n=33 Participants
|
22 Participants
n=33 Participants
|
46 Participants
n=66 Participants
|
|
Received Chemotherapy
No
|
17 Participants
n=33 Participants
|
19 Participants
n=33 Participants
|
36 Participants
n=66 Participants
|
|
Received Chemotherapy
Yes
|
16 Participants
n=33 Participants
|
14 Participants
n=33 Participants
|
30 Participants
n=66 Participants
|
|
On endocrine therapy
No
|
7 Participants
n=33 Participants
|
2 Participants
n=33 Participants
|
9 Participants
n=66 Participants
|
|
On endocrine therapy
Yes
|
26 Participants
n=33 Participants
|
31 Participants
n=33 Participants
|
57 Participants
n=66 Participants
|
|
Number of Comorbidities
0
|
15 Participants
n=33 Participants
|
15 Participants
n=33 Participants
|
30 Participants
n=66 Participants
|
|
Number of Comorbidities
1
|
14 Participants
n=33 Participants
|
12 Participants
n=33 Participants
|
26 Participants
n=66 Participants
|
|
Number of Comorbidities
2+
|
4 Participants
n=33 Participants
|
6 Participants
n=33 Participants
|
10 Participants
n=66 Participants
|
|
Had a primary care provider at enrollment
No
|
2 Participants
n=33 Participants
|
2 Participants
n=33 Participants
|
4 Participants
n=66 Participants
|
|
Had a primary care provider at enrollment
Yes
|
31 Participants
n=33 Participants
|
31 Participants
n=33 Participants
|
62 Participants
n=66 Participants
|
PRIMARY outcome
Timeframe: At baseline surveyPopulation: Number of eligible women invited to participate
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.
Outcome measures
| Measure |
Recruitment Population
n=160 Participants
Pre-randomization recruitment and enrollment
|
Intervention: 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.
|
|---|---|---|
|
Number of Breast Cancer Patients Successfully Recruited to Participate in the Study
|
66 Participants
|
—
|
SECONDARY outcome
Timeframe: Follow-Up Survey: 3 monthsPopulation: Intervention arm only; participants who completed the follow-up survey at 3 months post-randomization
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.
Outcome measures
| Measure |
Recruitment Population
n=28 Participants
Pre-randomization recruitment and enrollment
|
Intervention: 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.
|
|---|---|---|
|
Rating the Experience With the CCC Web-based, Survivorship Care Plan
|
4.4 score on a scale
Standard Deviation 2.0
|
—
|
SECONDARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Recruitment Population
n=26 Participants
Pre-randomization recruitment and enrollment
|
Intervention: CCC Website
n=28 Participants
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.
|
|---|---|---|
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Screening for second primary cancers
|
5 Participants
|
14 Participants
|
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Surveillance (mammogram)
|
0 Participants
|
3 Participants
|
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
General preventive care
|
23 Participants
|
25 Participants
|
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Comorbidity management
|
24 Participants
|
24 Participants
|
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Physical effects
|
2 Participants
|
3 Participants
|
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Psychological effects
|
15 Participants
|
20 Participants
|
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Reassurance about recurrence risk
|
1 Participants
|
1 Participants
|
|
Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services
Endocrine therapy management
|
13 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 3 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).
Outcome measures
| Measure |
Recruitment Population
n=26 Participants
Pre-randomization recruitment and enrollment
|
Intervention: CCC Website
n=28 Participants
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.
|
|---|---|---|
|
Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment
|
11 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Recruitment Population
n=26 Participants
Pre-randomization recruitment and enrollment
|
Intervention: CCC Website
n=28 Participants
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.
|
|---|---|---|
|
Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care
|
3.1 score on a scale
Standard Deviation 1.2
|
3.7 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who saw a PCP after completing the baseline survey are included in the analysis population
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).
Outcome measures
| Measure |
Recruitment Population
n=11 Participants
Pre-randomization recruitment and enrollment
|
Intervention: CCC Website
n=18 Participants
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.
|
|---|---|---|
|
Percentage of Patients That Communicated With PCP About Provider Roles
|
2 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Recruitment Population
n=26 Participants
Pre-randomization recruitment and enrollment
|
Intervention: CCC Website
n=28 Participants
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.
|
|---|---|---|
|
Knowledge About Team-based Survivorship Care
|
3.4 score on a scale
Standard Deviation 0.9
|
3.7 score on a scale
Standard Deviation 0.6
|
Adverse Events
Control: Static Care Plan
Intervention: CCC Website
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lauren Wallner, Ph.D.
University of Michigan Rogel Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place