CancerNCT03371147
CancerLife: Patient-Driven Solution in Cancer Care
A study testing CancerLife in people with Cancer, run by Saint John's Cancer Institute at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the use of a digital information and communication platform (DICP) in improving outcomes in patients with cancer and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CancerLife
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 7 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Diagnosis of cancer
- Receiving systemic treatment (chemotherapy, biotherapy/immunotherapy, hormonal therapy) that is expected to continue for at least 3 treatment sessions (approximately 9 weeks) from the time of enrollment
- Karnofsky Index ≥50%
- Able to understand and sign informed consent
- Owns and able to use an electronic communication device (smart phone, tablet, laptop, desktop) and answer simple self-report questionnaires on their own
Who cannot join
- Relevant cognitive impairment
- Participating in a therapeutic clinical trial
- Unable to read and comprehend English language text
Trial locations and contacts
1 site in 1 country.
United States1 site
John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica, California, 90404
About this study
Official title: Patient-Driven Solution in Cancer Care: Improving Outcomes Using a Digital Information and Communication Platform
The primary purpose of this study is to evaluate the use of a digital information and communication platform (DICP) in improving outcomes in patients with cancer and their caregivers.
Read the detailed description
This is a nonblinded, randomized, controlled trial of a digital information and communication platform (DICP) in self-reporting and monitoring of cancer and cancer-treatment related symptoms compared with usual care
Patients initiating and/or receiving systemic treatment for cancer will be enrolled in a nonblinded, randomized, controlled trial of a DICP in self-reporting and monitoring of cancer and cancer-treatment related symptoms compared with usual care. The study will require one (1) study encounter for consenting purposes.
All participants entering their information on the registration page will be contacted by a study team member for informed consent. Eligible subjects who agree to participate in the study and sign the consent form will be will be screened for eligibility. Participants will be randomized 1:1 to two arms:
Arm A will be asked to download a mobile application called CancerLife. CancerLife is a patient facing messaging app that gives cancer survivors and caregivers the ability to update family and friends of their health status through their existing social networks and at the same collect psychosocial and symptom reports that can be shared with the patients care team. Participants will be provided with online or printed instructions on the use of CancerLife and receive a user guide that they can refer on demand. CancerLife is a stand-alone application that is NOT integrated into the patient's electronic health record and will NOT trigger symptom alerts to the treatment team. Participants will be instructed to use the after-visit instructions provided to them by their treatment team for any symptoms or conditions that will require an evaluation by a healthcare provider.
Arm B will receive usual care provided for in the clinics. Usual care may vary between institutions, practices, and providers. Usual care may consist of but is not limited to any combination of the following: history and physical examination, review of systems, distress screening, symptom assessment measures, and/or interval quality of life measures.
Participants in Arm A will be asked to register on CancerLife to start using the broadcasting feature of the app. In addition, they will be asked to complete a series of questions through CancerLife at baseline and every 3 months for up to 2 years. Participants in Arm A will also be asked to complete FACT-G, GAD-7, DST, and QQPPI at those timepoints.
Participants in Arm B will receive usual care provided for in the clinics. They will also be asked to complete the FACT-G, GAD-7, DST, and QQPPI at baseline and every 3 months for up to 2 years..
- Conditions
- Cancer
- Being tested
- CancerLife
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CancerLifeOther
CancerLife is a patient facing messaging app that gives cancer survivors and caregivers the ability to update family and friends of their health status through their existing social networks and at the same collect psychosocial and symptom reports that can be shared with the patients care team.
| Study group | Role | What they receive |
|---|---|---|
| CancerLife | Experimental | Arm A will be asked to download a mobile application called CancerLife. CancerLife is a stand-alone application that is NOT integrated into the patient's electronic health record and will NOT trigger symptom alerts to the treatment team. Participants will be instructed to use the after-visit instructions provided to them by their treatment team for any symptoms or conditions that will require an evaluation by a healthcare provider. Receives: Other: CancerLife |
| Usual care | No intervention | Arm B will receive usual care provided for in the clinics. Usual care may vary between institutions, practices, and providers. Usual care may consist of but is not limited to any combination of the following: history and physical examination, review of systems, distress screening, symptom assessment measures, and/or interval quality of life measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Symptoms
Reduction in severity and occurrence of symptoms
Measured: 2 years
Secondary outcomes (6)
Quality of Life (QOL)
Functional Assessment of Cancer Therapy-General (FACT-G): subscale scores are added to derive total FACT-G score (0-108). The higher the score, the better the QOL.
Measured: 2 years
Anxiety
Generalized Anxiety Disorder 7-item (GAD-7) scale: score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Measured: 2 years
Depression
Depression Screening Tool (DST): score ranges from 0-6, patient with scores of >3 should be further evaluated with other diagnostic instruments.
Measured: 2 years
Emotional state
Tone analyzer and sentiment analysis using IBM Watson
Measured: 2 years
Quality of Physician-Patient Interaction
Questionnaire on the Quality of Physician-Patient Interaction (QQPPI): 14 items with each item ranging from 1-5, higher scores indicating more favorable ratings
Measured: 2 years
Emergency department visits/hospitalizations
Frequency of emergency department visits/hospitalizations
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start15 Mar 2018
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Healthy Platforms, LLC
- Responsible party
- Sponsor
- Investigators
- Santosh Kesari, MD PhD, Study chair, Saint John's Cancer InstituteMarlon G Saria, PhD RN FAAN, Principal investigator, John Wayne Cancer Institute at Providence Saint John's Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371147
- Sponsor's protocol ID
- JWCI-17-1001
- Status last verified
- Feb 2021
- First submitted
- 7 Dec 2017
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Driven Solution in Cancer Care: Improving Outcomes Using a Digital Information and Communication Platform
- ClinicalTrials.gov ID
- NCT03371147
- Acronym / sponsor ID
- JWCI-17-1001
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Collaborators
- Healthy Platforms, LLC
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 13 Dec 2017 (actual)
- 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.
The primary purpose of this study is to evaluate the use of a digital information and communication platform (DICP) in improving outcomes in patients with cancer and their caregivers.
Detailed description
This is a nonblinded, randomized, controlled trial of a digital information and communication platform (DICP) in self-reporting and monitoring of cancer and cancer-treatment related symptoms compared with usual care
Patients initiating and/or receiving systemic treatment for cancer will be enrolled in a nonblinded, randomized, controlled trial of a DICP in self-reporting and monitoring of cancer and cancer-treatment related symptoms compared with usual care. The study will require one (1) study encounter for consenting purposes.
All participants entering their information on the registration page will be contacted by a study team member for informed consent. Eligible subjects who agree to participate in the study and sign the consent form will be will be screened for eligibility. Participants will be randomized 1:1 to two arms:
Arm A will be asked to download a mobile application called CancerLife. CancerLife is a patient facing messaging app that gives cancer survivors and caregivers the ability to update family and friends of their health status through their existing social networks and at the same collect psychosocial and symptom reports that can be shared with the patients care team. Participants will be provided with online or printed instructions on the use of CancerLife and receive a user guide that they can refer on demand. CancerLife is a stand-alone application that is NOT integrated into the patient's electronic health record and will NOT trigger symptom alerts to the treatment team. Participants will be instructed to use the after-visit instructions provided to them by their treatment team for any symptoms or conditions that will require an evaluation by a healthcare provider.
Arm B will receive usual care provided for in the clinics. Usual care may vary between institutions, practices, and providers. Usual care may consist of but is not limited to any combination of the following: history and physical examination, review of systems, distress screening, symptom assessment measures, and/or interval quality of life measures.
Participants in Arm A will be asked to register on CancerLife to start using the broadcasting feature of the app. In addition, they will be asked to complete a series of questions through CancerLife at baseline and every 3 months for up to 2 years. Participants in Arm A will also be asked to complete FACT-G, GAD-7, DST, and QQPPI at those timepoints.
Participants in Arm B will receive usual care provided for in the clinics. They will also be asked to complete the FACT-G, GAD-7, DST, and QQPPI at baseline and every 3 months for up to 2 years..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CancerLife | Experimental | Other: CancerLifeArm A will be asked to download a mobile application called CancerLife. CancerLife is a stand-alone application that is NOT integrated into the patient's electronic health record and will NOT trigger symptom alerts to the treatment team. Participants will be instructed to use the after-visit instructions provided to them by their treatment team for any symptoms or conditions that will require an evaluation by a healthcare provider. |
| Usual care | No intervention | –Arm B will receive usual care provided for in the clinics. Usual care may vary between institutions, practices, and providers. Usual care may consist of but is not limited to any combination of the following: history and physical examination, review of systems, distress screening, symptom assessment measures, and/or interval quality of life measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Diagnosis of cancer
- Receiving systemic treatment (chemotherapy, biotherapy/immunotherapy, hormonal therapy) that is expected to continue for at least 3 treatment sessions (approximately 9 weeks) from the time of enrollment
- Karnofsky Index ≥50%
- Able to understand and sign informed consent
Key exclusion criteria (3 listed)
- Relevant cognitive impairment
- Participating in a therapeutic clinical trial
- Unable to read and comprehend English language text
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 |
|---|---|---|
| CancerLifeCancerLife is a patient facing messaging app that gives cancer survivors and caregivers the ability to update family and friends of their health status through their existing social networks and at the same collect psychosocial and symptom reports that can be shared with the patients care team. | Other | CancerLife |
Primary outcome
Self-Reported Symptoms
Time frame: 2 years
Reduction in severity and occurrence of symptoms
6 secondary outcomes
Quality of Life (QOL)
Time frame: 2 years
Anxiety
Time frame: 2 years
Depression
Time frame: 2 years
Emotional state
Time frame: 2 years
Quality of Physician-Patient Interaction
Time frame: 2 years
Emergency department visits/hospitalizations
Time frame: 2 years
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 9 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Santosh Kesari, MD PhD study chair
Saint John's Cancer Institute
Marlon G Saria, PhD RN FAAN principal investigator
John Wayne Cancer Institute at Providence Saint John's Health 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 CancerLife in people with Cancer, run by Saint John's Cancer Institute 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 6 inclusion and 3 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 9 Feb 2021. 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?
Self-Reported Symptoms (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.