CancerNCT03634696
m-Palliative Care Link: Improving Palliative Care for Late Stage Tanzanian Cancer Patients
A study testing mPCL in people with Cancer, run by Susan Miesfeldt at 1 site in Tanzania.
Trial summary
This work aims to improve late-stage cancer patients' access to high quality, patient-centered symptom assessment and control via the creation, field test, and outcomes assessment of a scalable mobile application (mPalliative Care Link; mPCL)-built around a locally-validated Palliative care Outcome Scale- that links a… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- mPCL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTanzania
- Study dates
- 15 Jun 2018to 20 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for field test if they meet the following criteria:
- Are ORCI inpatients with untreatable, late stage cancer
- Age 21 years or older
- Willing to enroll
- Able to understand and sign informed consent document
- Have four-month life expectancy or greater based on specialist assessment
Show all 11Show fewer
- Have caregivers available/willing to support outpatient care for duration of field test
- Have a local health worker to support their outpatient care who consents to participate in the field test (i.e., partner with palliative care specialists for the duration of field test)
- Live within 50 km of ORCI for access to medications and study nurse support
- Have experience using a mobile device as measured by past cell phone ownership
- Have completed primary school
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: m-Palliative Care Link: Improving Symptom Control and Information Exchange Among Specialists and Local Health Workers Treating Late Stage Tanzanian Cancer Patients
This work aims to improve late-stage cancer patients' access to high quality, patient-centered symptom assessment and control via the creation, field test, and outcomes assessment of a scalable mobile application (mPalliative Care Link; mPCL)-built around a locally-validated Palliative care Outcome Scale- that links a limited pool of existing Tanzanian palliative care specialists with patients, lay/family caregivers, and local health workers.
Read the detailed description
The investigators hypothesize that a mobile device-based symptom assessment, control and communication application (m-Palliative Care Link (mPCL) will extend access to palliative care specialists (hereafter named specialists), resulting in: a) symptom control information exchange between specialists, patients, and local health workers and b) reduced symptom burden in late-stage cancer patients.
This hypothesis will be tested by accomplishing the following specific aims in the two-year study period:
Aim 1. In partnership with local palliative care specialists, to design and create a secure mobile communication application (m-Palliative Care Link; mPCL) for facilitating remote assessment of and communication about patient symptom control needs among specialists, patients/caregivers, and local health workers (all of whom are referred to here as user groups). mPCL will:
- Regularly deliver the APCA POS (hereafter POS) to the cancer patient/caregiver via mobile device; allow them to complete the outcome scale on this device; and return responses to the specialist and local health worker for access via a secure website.
- Enable specialist POS review/action in partnership with the local health worker.
- Allow the specialist to communicate with the patient/caregiver and local health worker regarding further symptom assessment and control based on existing standards and the patient's desires and needs.
- Enable the specialist to generate/update patient records for ongoing review.
- Record and track symptom control as a trajectory throughout the patient's illness via collection, storage, and analysis of POS responses.
Aim 2. To usability test an mPCL prototype through a combination of hands-on observation/feedback and survey-based assessment of ease of use and suggestions for change among 5-7 participants from each user group. Usability test data will be used to improve mPCL design for subsequent field test (see Aim 3).
Aim 3. To field test and validate usability of mPCL among 45 late-stage cancer patients. Late-stage cancer patients, who are eligible for the study, will be enrolled/consented, trained on mPCL use, and provided with an mPCL-equipped mobile device prior to discharge from ORCI. An mPCL record and discharge care plan will be generated by the specialist on his/her personal computer and communicated with the patient's local health worker for review and ongoing remote care communication and coordination. Field tests will continue for 4 months or until patient death. Through a combination of surveys and interviews of user groups, investigators will: determine the feasibility, acceptability, barriers, and facilitators of mPCL for communication and action regarding symptom assessment, information exchange, and symptom control; further optimize mPCL for ongoing study; determine the projected per patient cost of mPCL implementation; and gather rich data on the symptom control needs of Tanzanian cancer patients.
Aim 4. To collect preliminary data comparing field test symptom outcomes with 45 usual care patients (ORCI palliative care clinic patients). Patients will be identified, enrolled and consented during their scheduled outpatient clinic visit. POS responses will be collected at the time of each clinic visit for up to 4 months. Through examination/between-group comparisons (mPCL intervention versus usual care) of symptom-based outcomes and medication type, dose and duration, investigators will collect preliminary data on mPCL impact that is critical to design of a future large-scale, randomized mPCL outcomes study.
- Conditions
- Cancer
- Being tested
- mPCL, Usual Care
- Keywords
- Late-stage, Palliative care, Novel technology, Communication
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPCLOther
Smart phone application to support palliative care among late-stage cancer patients
Usual CareOther
Usual care through OCRI palliative care clinic
| Study group | Role | What they receive |
|---|---|---|
| Field test participants | Experimental | Late-stage adult cancer patients seeking care at Ocean Road Cancer Center, consenting to participate in mPCL application field test Receives: Other: mPCL |
| Control participants | Active comparator | Late-stage adult cancer patients seeking care at Ocean Road Cancer Center, consenting to serve as controls for mPCL field test Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
APCA African Palliative Outcome Scale. Pain scale from 0-5 (low to high).
Measured: Up to 4 months
Secondary outcomes (1)
Application utility
Survey delivered via smart phone to all application users.
Measured: six week survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start15 Jun 2018
- Primary completion9 Aug 2019
- Study completion20 Jul 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Miesfeldt
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth, National Institutes of Health (NIH), Dimagi Inc., Muhimbili University of Health and Allied Sciences, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor-investigator, Susan Miesfeldt, MaineHealth
- Investigators
- Susan Miesfeldt, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634696
- Sponsor's protocol ID
- 1040841
- Other IDs
- R21TW010190
- Status last verified
- Oct 2021
- First submitted
- 10 Apr 2018
- Last updated
- 14 Oct 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 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- m-Palliative Care Link: Improving Symptom Control and Information Exchange Among Specialists and Local Health Workers Treating Late Stage Tanzanian Cancer Patients
- ClinicalTrials.gov ID
- NCT03634696
- Acronym / sponsor ID
- 1040841
- Conditions
- Cancer
- Keywords
- Late-stage, Palliative care, Novel technology, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Susan MiesfeldtUniversity, hospital or other
- Collaborators
- MaineHealth, National Institutes of Health (NIH), Dimagi Inc., Muhimbili University of Health and Allied Sciences, Fogarty International Center of the National Institute of Health
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 16 Aug 2018 (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.
This work aims to improve late-stage cancer patients' access to high quality, patient-centered symptom assessment and control via the creation, field test, and outcomes assessment of a scalable mobile application (mPalliative Care Link; mPCL)-built around a locally-validated Palliative care Outcome Scale- that links a limited pool of existing Tanzanian palliative care specialists with patients, lay/family caregivers, and local health workers.
Detailed description
The investigators hypothesize that a mobile device-based symptom assessment, control and communication application (m-Palliative Care Link (mPCL) will extend access to palliative care specialists (hereafter named specialists), resulting in: a) symptom control information exchange between specialists, patients, and local health workers and b) reduced symptom burden in late-stage cancer patients.
This hypothesis will be tested by accomplishing the following specific aims in the two-year study period:
Aim 1. In partnership with local palliative care specialists, to design and create a secure mobile communication application (m-Palliative Care Link; mPCL) for facilitating remote assessment of and communication about patient symptom control needs among specialists, patients/caregivers, and local health workers (all of whom are referred to here as user groups). mPCL will:
- Regularly deliver the APCA POS (hereafter POS) to the cancer patient/caregiver via mobile device; allow them to complete the outcome scale on this device; and return responses to the specialist and local health worker for access via a secure website.
- Enable specialist POS review/action in partnership with the local health worker.
- Allow the specialist to communicate with the patient/caregiver and local health worker regarding further symptom assessment and control based on existing standards and the patient's desires and needs.
- Enable the specialist to generate/update patient records for ongoing review.
- Record and track symptom control as a trajectory throughout the patient's illness via collection, storage, and analysis of POS responses.
Aim 2. To usability test an mPCL prototype through a combination of hands-on observation/feedback and survey-based assessment of ease of use and suggestions for change among 5-7 participants from each user group. Usability test data will be used to improve mPCL design for subsequent field test (see Aim 3).
Aim 3. To field test and validate usability of mPCL among 45 late-stage cancer patients. Late-stage cancer patients, who are eligible for the study, will be enrolled/consented, trained on mPCL use, and provided with an mPCL-equipped mobile device prior to discharge from ORCI. An mPCL record and discharge care plan will be generated by the specialist on his/her personal computer and communicated with the patient's local health worker for review and ongoing remote care communication and coordination. Field tests will continue for 4 months or until patient death. Through a combination of surveys and interviews of user groups, investigators will: determine the feasibility, acceptability, barriers, and facilitators of mPCL for communication and action regarding symptom assessment, information exchange, and symptom control; further optimize mPCL for ongoing study; determine the projected per patient cost of mPCL implementation; and gather rich data on the symptom control needs of Tanzanian cancer patients.
Aim 4. To collect preliminary data comparing field test symptom outcomes with 45 usual care patients (ORCI palliative care clinic patients). Patients will be identified, enrolled and consented during their scheduled outpatient clinic visit. POS responses will be collected at the time of each clinic visit for up to 4 months. Through examination/between-group comparisons (mPCL intervention versus usual care) of symptom-based outcomes and medication type, dose and duration, investigators will collect preliminary data on mPCL impact that is critical to design of a future large-scale, randomized mPCL outcomes study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Field test participants | Experimental | Other: mPCLLate-stage adult cancer patients seeking care at Ocean Road Cancer Center, consenting to participate in mPCL application field test |
| Control participants | Active comparator | Other: Usual CareLate-stage adult cancer patients seeking care at Ocean Road Cancer Center, consenting to serve as controls for mPCL field test |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Are ORCI inpatients with untreatable, late stage cancer
- Age 21 years or older
- Willing to enroll
- Able to understand and sign informed consent document
- Have four-month life expectancy or greater based on specialist assessment
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| mPCLSmart phone application to support palliative care among late-stage cancer patients | Other | Field test participants |
| Usual CareUsual care through OCRI palliative care clinic | Other | Control participants |
Primary outcome
Pain control
Time frame: Up to 4 months
APCA African Palliative Outcome Scale. Pain scale from 0-5 (low to high).
1 secondary outcome
Application utility
Time frame: six week survey
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 14 Oct 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.
Susan Miesfeldt, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPCL in people with Cancer, run by Susan Miesfeldt at 1 site in Tanzania.
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 11 inclusion and 1 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 14 Oct 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 Tanzania. 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?
Pain control (time frame: Up to 4 months). 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 14 Oct 2021.