Clinical trial NCT03634696: m-Palliative Care Link: Improving Palliative Care for Late Stage Tanzanian Cancer Patients
Official title: m-Palliative Care Link: Improving Symptom Control and Information Exchange Among Specialists and Local Health Workers Treating Late Stage Tanzanian Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Late-stage
Palliative care
Novel technology
Communication
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: MaineHealth
name: National Institutes of Health (NIH)
name: Dimagi Inc.
name: Muhimbili University of Health and Allied Sciences
name: Fogarty International Center of the National Institute of Health
First posted: 2018-08-16
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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
* 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

Exclusion Criteria:

• Not meeting inclusion criteria

Primary outcomes:
measure: Pain control
timeFrame: Up to 4 months
Secondary outcomes:
measure: Application utility
timeFrame: six week survey
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Ocean Road Cancer Institute
Study officials:
affiliation: MaineHealth
name: Susan Miesfeldt, MD
role: PRINCIPAL_INVESTIGATOR
References: