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| ID | Type | Description | Link |
|---|---|---|---|
| K07CA201052 | U.S. NIH Grant/Contract | View source | |
| HUM00115786 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCC Website | Experimental | The 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. |
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| Static care plan | Other | 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." |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline survey |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women being treated at the University of Michigan Rogel Cancer Center for stage 0-2 breast cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Lauren P Wallner, Ph.D | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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160 eligible women were invited to participate; 66 women enrolled (completed the baseline survey and were randomized).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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." |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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." |
| BG001 | CCC Website |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of eligible women invited to participate | Posted | Count of Participants | Participants | At baseline survey |
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Up to 3 months post-enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control: 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." |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Wallner, Ph.D. | University of Michigan Rogel Cancer Center | 734-232-0788 | lwallner@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Sep 16, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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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.
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| 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." |
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| Follow-Up Survey: 3 months |
| 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. | 3 months |
| 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). | 3 months |
| 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. | 3 months |
| 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). | 3 months |
| 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. | 3 months |
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.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Insurance | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Breast Cancer Stage at Diagnosis | Participants self-reported their breast cancer stage at diagnosis, with response options stage 0, stage I, stage II, stage III and stage IV, with higher values representing a higher stage at diagnosis. | 11 participants did not self-report this data. | Count of Participants | Participants |
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| Primary Surgical Treatment | Count of Participants | Participants |
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| Received radiation | Count of Participants | Participants |
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| Received Chemotherapy | Count of Participants | Participants |
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| On endocrine therapy | Count of Participants | Participants |
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| Number of Comorbidities | Count of Participants | Participants |
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| Had a primary care provider at enrollment | Count of Participants | Participants |
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| 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. | Intervention arm only; participants who completed the follow-up survey at 3 months post-randomization | Posted | Mean | Standard Deviation | score on a scale | Follow-Up Survey: 3 months |
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| 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. | Posted | Count of Participants | Participants | 3 months |
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| 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). | Posted | Count of Participants | Participants | 3 months |
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|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
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| 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). | Participants who saw a PCP after completing the baseline survey are included in the analysis population | Posted | Count of Participants | Participants | 3 months |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | 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. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Hispanic |
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| Asian |
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| Other |
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| Private |
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| Other not employed |
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| Bilateral mastectomy |
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| 2+ |
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| General preventive care |
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| Comorbidity management |
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| Physical effects |
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| Psychological effects |
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| Reassurance about recurrence risk |
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| Endocrine therapy management |
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