m-Palliative Care Link: Improving Palliative Care for Late Stage Tanzanian Cancer Patients

• ClinicalTrials.gov Identifier: NCT03634696
• Recruitment Status: Completed
• First Posted: August 16, 2018
• Last Update Posted: October 14, 2021
• Sponsor: Susan Miesfeldt
• 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
• Information provided by (Responsible Party): Susan Miesfeldt, MaineHealth

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Other: mPCL; Other: Usual Care	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: m-Palliative Care Link: Improving Symptom Control and Information Exchange Among Specialists and Local Health Workers Treating Late Stage Tanzanian Cancer Patients
• Actual Study Start Date: June 15, 2018
• Actual Primary Completion Date: August 9, 2019
• Actual Study Completion Date: July 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Field test participants; Late-stage adult cancer patients seeking care at Ocean Road Cancer Center, consenting to participate in mPCL application field test	Other: mPCL; Smart phone application to support palliative care among late-stage cancer patients
Active Comparator: Control participants; Late-stage adult cancer patients seeking care at Ocean Road Cancer Center, consenting to serve as controls for mPCL field test	Other: Usual Care; Usual care through OCRI palliative care clinic

Outcome Measures

Primary Outcome Measures :

1. Pain control [ Time Frame: Up to 4 months ]
   APCA African Palliative Outcome Scale. Pain scale from 0-5 (low to high).

Secondary Outcome Measures :

1. Application utility [ Time Frame: six week survey ]
   Survey delivered via smart phone to all application users.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Tanzania

Ocean Road Cancer Institute

Dar Es Salaam, Tanzania

Sponsors and Collaborators

Susan Miesfeldt

MaineHealth

National Institutes of Health (NIH)

Dimagi Inc.

Muhimbili University of Health and Allied Sciences

Fogarty International Center of the National Institute of Health

Investigators

• Principal Investigator: Susan Miesfeldt, MD; MaineHealth

More Information

• Responsible Party: Susan Miesfeldt, Principal Investigator, MaineHealth
• ClinicalTrials.gov Identifier: NCT03634696
• Other Study ID Numbers: 1040841; R21TW010190 ( U.S. NIH Grant/Contract )
• First Posted: August 16, 2018
• Last Update Posted: October 14, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susan Miesfeldt, MaineHealth:

Late-stage; Palliative care; Novel technology; Communication