Bladder CarcinomaNCT02408406
PatientCareAnywhere Internet-Based Software in Improving Communication and Education in Patients With Cancer and Their Healthcare Providers
A study testing Communication Intervention, Educational Intervention and Internet-Based Intervention in people with Bladder Carcinoma and Breast Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This partially randomized pilot clinical trial develops and studies a software program, called PatientCareAnywhere, to see whether it can help patients communicate with their doctors and other healthcare providers, and educate themselves about their cancer and treatment options. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Carcinoma, Breast Carcinoma, Colorectal Carcinoma
- What is being tested?
- Communication Intervention, Educational Intervention and Internet-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2015to 19 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PHASE I AIM 1 (STAKEHOLDER INPUT)
- PHASE I AIM 1: Malignant diagnosis in any cancer type at any stage
- PHASE I AIM 1: Receiving any type of cancer treatment
- PHASE I AIM 1: Life expectancy of at least six months
- PHASE I AIM 1: Current outpatient status
- PHASE I AIM 1: Fluent in English
Show all 28Show fewer
- PHASE I AIM 1: Internet access at home
- PHASE I AIM 3.1 (EVALUATION STUDY)
- PHASE I AIM 3.1: Malignant diagnosis in any cancer type at any stage
- PHASE I AIM 3.1: Receiving any type of cancer treatment
- PHASE I AIM 3.1: Life expectancy of at least six months
- PHASE I AIM 3.1: Current outpatient status
- PHASE I AIM 3.1: Fluent in English
- PHASE I AIM 3.1: Internet access at home
- PHASE I AIM 3.2 (PILOT STUDY)
- PHASE I AIM 3.2: Malignant diagnosis in breast, gynecologic (GYN), genitourinary (GU) cancer at any stage
- PHASE I AIM 3.2: Receiving surgery and/or chemotherapy treatment
- PHASE I AIM 3.2: Life expectancy of at least six months
- PHASE I AIM 3.2: Current outpatient status (participation will be suspended during hospitalization)
- PHASE I AIM 3.2: Fluent in English
- PHASE I AIM 3.2: Internet access at home
- PHASE II AIM 2 (RANDOMIZED CONTROLLED TRIAL)
- PHASE II AIM 2: Malignant diagnosis of breast, lung, or colorectal cancer at any stage
- PHASE II AIM 2: Receiving any type of cancer treatment
- PHASE II AIM 2: Life expectancy of at least six months
- PHASE II AIM 2: Current medical oncology outpatient status (participation will be suspended during hospitalization)
- PHASE II AIM 2: Fluent in English
- PHASE II AIM 2: Internet access at home
Who cannot join
- PHASE I AIM 1 (STAKEHOLDER INPUT) EXCLUSION
- PHASE I AIM 1: Clinical evidence of cognitive or psychological impairment
- PHASE I AIM 1: Prisoners and pregnant women
- PHASE I AIM 3.1 (EVALUATION STUDY) EXCLUSION
- PHASE I AIM 3.1: Clinical evidence of cognitive or psychological impairment
- PHASE I AIM 3.1: Prisoners and pregnant women
Show all 14Show fewer
- PHASE I AIM 3.2 (PILOT STUDY) EXCLUSION
- PHASE I AIM 3.2: Clinical evidence of cognitive or psychological impairment
- PHASE I AIM 3.2: Prisoners and pregnant women
- PHASE I AIM 3.2: Currently participating in other psychosocial studies
- PHASE II AIM 2 (RANDOMIZED CONTROLLED TRIAL) EXCLUSION
- PHASE II AIM 2: Clinical evidence of cognitive or psychological impairment
- PHASE II AIM 2: Prisoners and pregnant women
- PHASE II AIM 2: Currently participating in other psychosocial studies
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: PatientCareAnywhere: Patient Support and Empowerment Across the Care Continuum
This partially randomized pilot clinical trial develops and studies a software program, called PatientCareAnywhere, to see whether it can help patients communicate with their doctors and other healthcare providers, and educate themselves about their cancer and treatment options. A program that can help patients learn about their cancer and treatment options, and allows the patient's healthcare providers to receive their questionnaire results, may help patients identify and get help to treat their symptoms.
Read the detailed description
PRIMARY OBJECTIVES:
- Solicit stakeholder feedback on expected system functions, perceived usefulness and impacts, and potential adoption barriers via 10 focus groups. (Human Subjects [HS], Phase I) II. Develop the software prototype using an iterative user-centered design process and leverage the technical design and components from an existing clinic-based biopsychosocial screening tool and an existing patient portal solution as well as the patient education contents from City of Hope (COH). (Phase I) III. Conduct two usability tests with 24 subjects each to evaluate the usability, usefulness, and acceptability of the prototype system developed in Aim 2. (HS, Phase I) IV. Conduct a 50-subject pilot evaluation study to demonstrate the feasibility of our technical solution and our Phase II randomized controlled trial protocol design. (HS, Phase I) V. Enhance the software system to add more administrative/customization features and to expand the education contents to cover more cancer types and treatment options. (Phase II) VI. Conduct a 2-year 516-subject randomized control trial to test the effectiveness hypothesis. (HS, Phase II)
OUTLINE:
FOCUS GROUPS: Ten, 90-minute focus group sessions are conducted, composed of patients; caregivers, friends, and family members; cancer treatment professionals; supportive care professionals and community support professionals. Sessions address what functions participants expect to see in the program, what benefits are expected, and any expected barriers for using the program.
USABILITY EVALUATION (DESIGN-ORIENTED \& METRIC-ORIENTED): Patients, caregivers, and clinical care/support professionals in each type of evaluation undergo a 60-minute one-on-one session in which they are assigned tasks to complete using the system, and an observer records how the tasks are completed. Participants are also requested to talk aloud while performing the task. Participants in the metric-oriented evaluation respond to usability and usefulness questionnaires.
PILOT STUDY \& RANDOMIZED CONTROLLED TRIAL: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION GROUP): Patients are encouraged to use the PatientCareAnywhere program at least once weekly either in the clinic or at home. Patients receive reminder emails after 1 week of inactivity. If patients indicate they are experiencing moderate to severe symptoms, an alert message is sent to at least 1 member of the patient's support team along with a list of expected response times.
ARM II (CONTROL GROUP): Patients receive usual care, including a one-time use of SupportScreen, a touchscreen questionnaire system that identifies patient issues before appointments, at the clinic during the first treatment consultation after diagnosis. Consultation, printed education materials, and specialist referrals may be generated based on SupportScreen responses.
- Conditions
- Bladder Carcinoma, Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Female Reproductive System Neoplasm, Malignant Neoplasm
- Being tested
- Communication Intervention, Educational Intervention, Internet-Based Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Urinary Bladder Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionOther
Use PatientCareAnywhere system
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Use PatientCareAnywhere system
Internet-Based InterventionOther
Use PatientCareAnywhere system
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PatientCareAnywhere program system) | Experimental | Patients are encouraged to use the PatientCareAnywhere program at least once weekly either in the clinic or at home. Patients receive reminder emails after 1 week of inactivity. If patients indicate they are experiencing moderate to severe symptoms, an alert message is sent to at least 1 member of the patient's support team along with a list of expected response times. Receives: Other: Communication Intervention; Other: Educational Intervention; Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (usual care) | Active comparator | Patients receive usual care, including a one-time use of SupportScreen, a touchscreen questionnaire system that identifies patient issues before appointments, at the clinic during the first treatment consultation after diagnosis. Consultation, printed education materials, and specialist referrals may be generated based on SupportScreen responses. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy-General (FACT-G) scores
Separate analysis will be carried out for the per-protocol (PP) population and intent-to-treat (ITT) population. For the PP population, a repeated measures analysis of variance will be employed. In this model, FACT-G scores are the response variables. Time, patient group and their interaction are the predictors. For the ITT population, a random effect model will be fitted to the data. The model can also adjust for covariates of potential interests. Exploratory assessments may also include effects of other variables of interest, such as demographic and baseline values.
Measured: Up to 6 months
Secondary outcomes (2)
Change in self-efficacy as measured by the revised Chronic Disease Self-Efficacy Scale
Analysis steps follow those for the primary outcome.
Measured: Baseline to up to 6 months
Change in health resource utilization
Measured by number of unplanned hospitalizations, emergency room visits, intensive care unit stays, diagnostic tests, and clinic no-shows. Analysis steps follow those for the primary outcome.
Measured: Baseline to up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study start7 Jul 2015
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen Clark, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408406
- Sponsor's protocol ID
- 15025
- Other IDs
- NCI-2015-00554, 115352, 15025, R44CA192588
- Status last verified
- Jun 2024
- First submitted
- 31 Mar 2015
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baik SH, Clark K, Sanchez M, Loscalzo M, Celis A, Razavi M, Yang D, Dale W, Haas N. Usability and Preliminary Efficacy of an Adaptive Supportive Care System for Patients With Cancer: Pilot Randomized Controlled Trial. JMIR Cancer. 2024 Jul 10;10:e49703. doi: 10.2196/49703.
PubMed 38986134
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PatientCareAnywhere: Patient Support and Empowerment Across the Care Continuum
- ClinicalTrials.gov ID
- NCT02408406
- Acronym / sponsor ID
- 15025
- Conditions
- Bladder Carcinoma, Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Female Reproductive System Neoplasm, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This partially randomized pilot clinical trial develops and studies a software program, called PatientCareAnywhere, to see whether it can help patients communicate with their doctors and other healthcare providers, and educate themselves about their cancer and treatment options. A program that can help patients learn about their cancer and treatment options, and allows the patient's healthcare providers to receive their questionnaire results, may help patients identify and get help to treat their symptoms.
Detailed description
PRIMARY OBJECTIVES:
- Solicit stakeholder feedback on expected system functions, perceived usefulness and impacts, and potential adoption barriers via 10 focus groups. (Human Subjects [HS], Phase I) II. Develop the software prototype using an iterative user-centered design process and leverage the technical design and components from an existing clinic-based biopsychosocial screening tool and an existing patient portal solution as well as the patient education contents from City of Hope (COH). (Phase I) III. Conduct two usability tests with 24 subjects each to evaluate the usability, usefulness, and acceptability of the prototype system developed in Aim 2. (HS, Phase I) IV. Conduct a 50-subject pilot evaluation study to demonstrate the feasibility of our technical solution and our Phase II randomized controlled trial protocol design. (HS, Phase I) V. Enhance the software system to add more administrative/customization features and to expand the education contents to cover more cancer types and treatment options. (Phase II) VI. Conduct a 2-year 516-subject randomized control trial to test the effectiveness hypothesis. (HS, Phase II)
OUTLINE:
FOCUS GROUPS: Ten, 90-minute focus group sessions are conducted, composed of patients; caregivers, friends, and family members; cancer treatment professionals; supportive care professionals and community support professionals. Sessions address what functions participants expect to see in the program, what benefits are expected, and any expected barriers for using the program.
USABILITY EVALUATION (DESIGN-ORIENTED \& METRIC-ORIENTED): Patients, caregivers, and clinical care/support professionals in each type of evaluation undergo a 60-minute one-on-one session in which they are assigned tasks to complete using the system, and an observer records how the tasks are completed. Participants are also requested to talk aloud while performing the task. Participants in the metric-oriented evaluation respond to usability and usefulness questionnaires.
PILOT STUDY \& RANDOMIZED CONTROLLED TRIAL: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION GROUP): Patients are encouraged to use the PatientCareAnywhere program at least once weekly either in the clinic or at home. Patients receive reminder emails after 1 week of inactivity. If patients indicate they are experiencing moderate to severe symptoms, an alert message is sent to at least 1 member of the patient's support team along with a list of expected response times.
ARM II (CONTROL GROUP): Patients receive usual care, including a one-time use of SupportScreen, a touchscreen questionnaire system that identifies patient issues before appointments, at the clinic during the first treatment consultation after diagnosis. Consultation, printed education materials, and specialist referrals may be generated based on SupportScreen responses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (PatientCareAnywhere program system) | Experimental | Other: Communication Intervention, Other: Educational Intervention, Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients are encouraged to use the PatientCareAnywhere program at least once weekly either in the clinic or at home. Patients receive reminder emails after 1 week of inactivity. If patients indicate they are experiencing moderate to severe symptoms, an alert message is sent to at least 1 member of the patient's support team along with a list of expected response times. |
| Arm II (usual care) | Active comparator | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive usual care, including a one-time use of SupportScreen, a touchscreen questionnaire system that identifies patient issues before appointments, at the clinic during the first treatment consultation after diagnosis. Consultation, printed education materials, and specialist referrals may be generated based on SupportScreen responses. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- PHASE I AIM 1 (STAKEHOLDER INPUT)
- PHASE I AIM 1: Malignant diagnosis in any cancer type at any stage
- PHASE I AIM 1: Receiving any type of cancer treatment
- PHASE I AIM 1: Life expectancy of at least six months
- PHASE I AIM 1: Current outpatient status
Key exclusion criteria (14 listed)
- PHASE I AIM 1 (STAKEHOLDER INPUT) EXCLUSION
- PHASE I AIM 1: Clinical evidence of cognitive or psychological impairment
- PHASE I AIM 1: Prisoners and pregnant women
- PHASE I AIM 3.1 (EVALUATION STUDY) EXCLUSION
- PHASE I AIM 3.1: Clinical evidence of cognitive or psychological impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication InterventionUse PatientCareAnywhere system | Other | Arm I (PatientCareAnywhere program system) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalUse PatientCareAnywhere system | Other | Arm I (PatientCareAnywhere program system) |
| Internet-Based InterventionUse PatientCareAnywhere system | Other | Arm I (PatientCareAnywhere program system) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (PatientCareAnywhere program system), Arm II (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (PatientCareAnywhere program system), Arm II (usual care) |
Primary outcome
Functional Assessment of Cancer Therapy-General (FACT-G) scores
Time frame: Up to 6 months
Separate analysis will be carried out for the per-protocol (PP) population and intent-to-treat (ITT) population. For the PP population, a repeated measures analysis of variance will be employed. In this model, FACT-G scores are the response variables. Time, patient group and their interaction are the predictors. For the ITT population, a random effect model will be fitted to the data. The model can also adjust for covariates of potential interests. Exploratory assessments may also include effects of other variables of interest, such as demographic and baseline values.
2 secondary outcomes
Change in self-efficacy as measured by the revised Chronic Disease Self-Efficacy Scale
Time frame: Baseline to up to 6 months
Change in health resource utilization
Time frame: Baseline to up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 38986134Baik SH, Clark K, Sanchez M, Loscalzo M, Celis A, Razavi M, Yang D, Dale W, Haas N. Usability and Preliminary Efficacy of an Adaptive Supportive Care System for Patients With Cancer: Pilot Randomized Controlled Trial. JMIR Cancer. 2024 Jul 10;10:e49703. doi: 10.2196/49703.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Clark principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Intervention, Educational Intervention and Internet-Based Intervention in people with Bladder Carcinoma and Breast Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-General (FACT-G) scores (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.