CancerNCT03094741
Evaluation of a Mobile Digital Solution for Cancer Care and Research
A study testing CancerLife in people with Cancer and Caregivers, run by Saint John's Cancer Institute at 1 site in United States.
Trial summary
The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study is meant to be the preparatory work for an intervention study to test the effect of Mobile Digital Solutions on improving patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Caregivers, Quality of Life
- 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
- 1 Apr 2017to 5 Nov 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
- Established diagnosis of cancer
- Karnofsky Index ≥50%
- Age > 18 years
Who cannot join
- Relevant cognitive impairment
- Insufficient knowledge of English language to complete the survey
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: Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study
The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study is meant to be the preparatory work for an intervention study to test the effect of Mobile Digital Solutions on improving patient outcomes by prompting early interventions for symptom relief and support of patient and family caregiver quality of life (QOL).
Read the detailed description
Demographic information and patient-reported symptoms will be collected from study participants through a mobile health application called CancerLife that they can download (FREE) from their mobile device app store (Android or iOS). Participants will be asked to broadcast their emotional and physical status through a list of symptom list within the app as well as how that symptom is impacting their quality of life and activities of daily living. This data will be collected inside the application and display in easy to understand pie charts. Participants will also have the option to broadcast their entry to their social network.
Since the objective of the current feasibility study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden and QOL data, the investigators will include a standard validated instrument (FACT-G: Functional Assessment of Cancer Therapy - General) as part of this study. Participants will be asked to complete the FACT-G after initial registration and weekly for up to 4 weeks. Participants will receive electronic mail messages with a link to CancerLife weekly as a reminder to access the website.
- Conditions
- Cancer, Caregivers, Quality of Life
- 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 mobile digital solution that allows patients to broadcast their health status inside a private invitation only group, text, email or publicly in Facebook or Instagram. By doing, so the patient collects his/her own patient-reported outcomes data and then share this data with their doctor or care team.
| Study group | Role | What they receive |
|---|---|---|
| CancerLife Feasibility Group | Experimental | Participants will be recruited through advertisements targeted to a specific audience using the keywords cancer and cancer survivors Receives: Other: CancerLife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility/ Participation Rate
number of individuals who participate in the study divided by the number of individuals who opened the link
Measured: 4 weeks
Secondary outcomes (5)
Open Rate
number of individuals who open the link divided by total number of individuals reached by the advertisement
Measured: 4 weeks
Refusal rate
number of individuals who declined to participate divided by the number of individuals who opened the link
Measured: 4 weeks
Retention rate
number of mission data divided by total number of items available
Measured: 4 weeks
Rate of missing data
number of mission data divided by total number of items available
Measured: 4 weeks
Participant Satisfaction
describe the usability, satisfaction, and desirability of the Mobile Digital Solution using a patient experience survey at the end of the study
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Apr 2017
- Primary completion4 Sep 2020
- Study completion5 Nov 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- CancerLife
- Responsible party
- Sponsor
- Investigators
- Santosh Kesari, MD, PhD, Study chair, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094741
- Sponsor's protocol ID
- JWCI-17-0301
- Status last verified
- Feb 2021
- First submitted
- 21 Mar 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
- Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03094741
- Acronym / sponsor ID
- JWCI-17-0301
- Conditions
- Cancer, Caregivers, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Collaborators
- CancerLife
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 29 Mar 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 pilot study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study is meant to be the preparatory work for an intervention study to test the effect of Mobile Digital Solutions on improving patient outcomes by prompting early interventions for symptom relief and support of patient and family caregiver quality of life (QOL).
Detailed description
Demographic information and patient-reported symptoms will be collected from study participants through a mobile health application called CancerLife that they can download (FREE) from their mobile device app store (Android or iOS). Participants will be asked to broadcast their emotional and physical status through a list of symptom list within the app as well as how that symptom is impacting their quality of life and activities of daily living. This data will be collected inside the application and display in easy to understand pie charts. Participants will also have the option to broadcast their entry to their social network.
Since the objective of the current feasibility study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden and QOL data, the investigators will include a standard validated instrument (FACT-G: Functional Assessment of Cancer Therapy - General) as part of this study. Participants will be asked to complete the FACT-G after initial registration and weekly for up to 4 weeks. Participants will receive electronic mail messages with a link to CancerLife weekly as a reminder to access the website.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CancerLife Feasibility Group | Experimental | Other: CancerLifeParticipants will be recruited through advertisements targeted to a specific audience using the keywords cancer and cancer survivors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of cancer
- Karnofsky Index ≥50%
- Age > 18 years
Key exclusion criteria (2 listed)
- Relevant cognitive impairment
- Insufficient knowledge of English language to complete the survey
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 mobile digital solution that allows patients to broadcast their health status inside a private invitation only group, text, email or publicly in Facebook or Instagram. By doing, so the patient collects his/her own patient-reported outcomes data and then share this data with their doctor or care team. | Other | CancerLife Feasibility Group |
Primary outcome
Feasibility/ Participation Rate
Time frame: 4 weeks
number of individuals who participate in the study divided by the number of individuals who opened the link
5 secondary outcomes
Open Rate
Time frame: 4 weeks
Refusal rate
Time frame: 4 weeks
Retention rate
Time frame: 4 weeks
Rate of missing data
Time frame: 4 weeks
Participant Satisfaction
Time frame: 4 weeks
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
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 and Caregivers, 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 3 inclusion and 2 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?
Feasibility/ Participation Rate (time frame: 4 weeks). 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.