Breast Cancer Female, Cancer Survivors, Early-stage Breast Cancer, Survivorship, Transitional Care
Conditions
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
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.
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Breast Cancer Patients Successfully Recruited to Participate in the Study | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | 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. |
| Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment | 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). |
| Rating the Experience With the CCC Web-based, Survivorship Care Plan | 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. |
| Percentage of Patients That Communicated With PCP About Provider Roles | 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). |
| Knowledge About Team-based Survivorship Care | 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. |
| Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 66 |
Baseline characteristics
| Characteristic | Total | Static Care Plan | CCC Website |
|---|---|---|---|
| Age, Continuous | 56.0 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 Participants | 3 Participants | 2 Participants |
| Breast Cancer Stage at Diagnosis Stage 1 | 29 Participants | 14 Participants | 15 Participants |
| Breast Cancer Stage at Diagnosis Stage 2 | 21 Participants | 14 Participants | 7 Participants |
| Education College graduate or more | 43 Participants | 23 Participants | 20 Participants |
| Education High school/some college | 23 Participants | 10 Participants | 13 Participants |
| Employment Employed | 34 Participants | 17 Participants | 17 Participants |
| Employment Other not employed | 14 Participants | 6 Participants | 8 Participants |
| Employment Retired | 18 Participants | 10 Participants | 8 Participants |
| Had a primary care provider at enrollment No | 4 Participants | 2 Participants | 2 Participants |
| Had a primary care provider at enrollment Yes | 62 Participants | 31 Participants | 31 Participants |
| Insurance Medicaid/Other government | 4 Participants | 3 Participants | 1 Participants |
| Insurance Medicare | 18 Participants | 10 Participants | 8 Participants |
| Insurance Private | 44 Participants | 20 Participants | 24 Participants |
| Number of Comorbidities 0 | 30 Participants | 15 Participants | 15 Participants |
| Number of Comorbidities 1 | 26 Participants | 14 Participants | 12 Participants |
| Number of Comorbidities 2+ | 10 Participants | 4 Participants | 6 Participants |
| On endocrine therapy No | 9 Participants | 7 Participants | 2 Participants |
| On endocrine therapy Yes | 57 Participants | 26 Participants | 31 Participants |
| Primary Surgical Treatment Bilateral mastectomy | 14 Participants | 8 Participants | 6 Participants |
| Primary Surgical Treatment Lumpectomy | 37 Participants | 20 Participants | 17 Participants |
| Primary Surgical Treatment Unilateral mastectomy | 15 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 56 Participants | 27 Participants | 29 Participants |
| Received Chemotherapy No | 36 Participants | 17 Participants | 19 Participants |
| Received Chemotherapy Yes | 30 Participants | 16 Participants | 14 Participants |
| Received radiation No | 20 Participants | 9 Participants | 11 Participants |
| Received radiation Yes | 46 Participants | 24 Participants | 22 Participants |
| Sex: Female, Male Female | 66 Participants | 33 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruitment Population | Number of Breast Cancer Patients Successfully Recruited to Participate in the Study | 66 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recruitment Population | Knowledge About Team-based Survivorship Care | 3.4 score on a scale | Standard Deviation 0.9 |
| Intervention: CCC Website | Knowledge About Team-based Survivorship Care | 3.7 score on a scale | Standard Deviation 0.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recruitment Population | Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care | 3.1 score on a scale | Standard Deviation 1.2 |
| Intervention: CCC Website | Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care | 3.7 score on a scale | Standard Deviation 1 |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recruitment Population | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Surveillance (mammogram) | 0 Participants |
| Recruitment Population | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Screening for second primary cancers | 5 Participants |
| Recruitment Population | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | General preventive care | 23 Participants |
| Recruitment Population | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Comorbidity management | 24 Participants |
| Recruitment Population | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Physical effects | 2 Participants |
| Recruitment Population | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Psychological effects | 15 Participants |
| Recruitment Population | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Reassurance about recurrence risk | 1 Participants |
| Recruitment Population | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Endocrine therapy management | 13 Participants |
| Intervention: CCC Website | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Endocrine therapy management | 15 Participants |
| Intervention: CCC Website | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Surveillance (mammogram) | 3 Participants |
| Intervention: CCC Website | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Physical effects | 3 Participants |
| Intervention: CCC Website | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Screening for second primary cancers | 14 Participants |
| Intervention: CCC Website | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Reassurance about recurrence risk | 1 Participants |
| Intervention: CCC Website | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | General preventive care | 25 Participants |
| Intervention: CCC Website | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Psychological effects | 20 Participants |
| Intervention: CCC Website | Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services | Comorbidity management | 24 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruitment Population | Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment | 11 Participants |
| Intervention: CCC Website | Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment | 18 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruitment Population | Percentage of Patients That Communicated With PCP About Provider Roles | 2 Participants |
| Intervention: CCC Website | Percentage of Patients That Communicated With PCP About Provider Roles | 12 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recruitment Population | Rating the Experience With the CCC Web-based, Survivorship Care Plan | 4.4 score on a scale | Standard Deviation 2 |