NCT03634696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

April 10, 2018

Last Update Submit

October 13, 2021

Conditions

Keywords

Late-stagePalliative careNovel technologyCommunication

Outcome Measures

Primary Outcomes (1)

  • Pain control

    APCA African Palliative Outcome Scale. Pain scale from 0-5 (low to high).

    Up to 4 months

Secondary Outcomes (1)

  • Application utility

    six week survey

Study Arms (2)

Field test participants

EXPERIMENTAL

Late-stage adult cancer patients seeking care at Ocean Road Cancer Center, consenting to participate in mPCL application field test

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

Other: Usual Care

Interventions

mPCLOTHER

Smart phone application to support palliative care among late-stage cancer patients

Field test participants

Usual care through OCRI palliative care clinic

Control participants

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ocean Road Cancer Institute

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

NeoplasmsCommunication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Susan Miesfeldt, MD

    MaineHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2018

First Posted

August 16, 2018

Study Start

June 15, 2018

Primary Completion

August 9, 2019

Study Completion

July 20, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations