Clinical trial · Interventional
A Novel mHealth Approach to Assess and Manage Palliative Care Needs for Cancer Patients in Kigali
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding
Summary
Brief summary (as posted)
Palliative care is an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness such as cancer, through the prevention and relief of suffering by means of early identification and treatment of pain and other physical and psychosocial problems. Despite the rising incidence of cancer, the availability of comprehensive palliative care services across Sub Saharan Africa is extremely limited. The current study will test the efficacy of the newly developed smart phone based symptom evaluation app (application), in improving the management of the palliative care needs of patients with advanced cancer in Rwanda. RPCHO is the Rwanda Palliative Care and Hospice Organization that provides palliative care services to advanced cancer patients in Rwanda. About 80 patients enrolled under the RPCHO will be enrolled in the current study. Those who agree to take part in the study will be randomly assigned to either a standard care group or intervention group. Patients in both the arms will continue to receive the standard palliative care currently provided at the RPCHO. Additionally, patients in the intervention group will receive new smart-phone application based alerts, bi-weekly, on their mobile phone to fill out the short symptom assessment form. In addition, patients will also be able to complete a symptom assessment at any time they feel that their symptoms are poorly controlled or getting worse. The team at RPCHO will have desktop based dashboard where they will be able to track all patient's information. This will assist them in early identification and response to any worsening symptoms. Patients enrolled in both standard arm and intervention arm, will be asked to make three visits at the RPCHO at baseline, at 6 weeks, at 3 months. During this visits the RPCHO research staff will conduct their physical and psychological assessment. We hope to find significant improvement in pain score, other symptoms and quality of life, as measured by standard validated scores, for patients enrolled under the intervention arm (using the smart phone app) as compared to standard care arm at 6 weeks and at 3 months. Thus we hope to demonstrate that the new smartphone-based app can be successfully used for both the assessment and management of pain and other symptoms and providing palliative care services for advanced cancer patients in low and middle income countries.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Smart Phone based symptom evaluation application | Other | — | UNRESOLVED |
| Standard palliative care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- Patients in this arm will receive standard palliative care currently provided at the Rwanda Palliative and Hospice Care Organization (RPCHO). Standard care also includes regular follow-up phone calls and home visits by the RPCHO staff, though the timing of these calls is variable and is selected by the discretion of the team. In addition, patients can contact providers on a landline number available during business hours and staffed by an on-call palliative care provider as and when needed.
- interventionNames
- Other: Standard palliative care
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Patients in this arm, in addition to the standard palliative care currently provided at the RPCHO, will receive biweekly frequency reminders to fill out the African Palliative Care Outcomes Scale (APCA POS) on the new smart phone based symptom evaluation application on their phones. It is a short symptom assessment questionnaire with responses on 5-point severity scale. In addition to bi-weekly, patients can complete the symptom assessment at any time they feel their symptoms are poorly controlled. The team at RPCHO will be able to track all enrolled patients on a desktop dashboard. Any score of 2 or higher will be flagged. The providers at RPCHO will respond to such patients during business hours via call or text and will advise the patients as indicated or triage to a fellow team member.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years old; * Diagnosed with advanced cancer and in moderate or severe pain, as defined by use of World Health Organization (WHO) as requiring step 2 drugs (Tramadol or Codeine) or WHO step 3 drugs (narcotics other than Codeine) to manage their pain. * Eligible patients or their primary care giver must have a smartphone and/or have a family member that lives at home with a smartphone; and Exclusion Criteria: * Projected life expectancy of \<3 months at the time of enrollment, to be estimated by their healthcare provider * Patients enrolled in the smartphone application development phases (earlier than RCT) of the study
References
Publications (8)
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- BACKGROUNDHarding R, Selman L, Agupio G, Dinat N, Downing J, Gwyther L, Mashao T, Mmoledi K, Moll T, Sebuyira LM, Panjatovic B, Higginson IJ. Validation of a core outcome measure for palliative care in Africa: the APCA African Palliative Outcome Scale. Health Qual Life Outcomes. 2010 Jan 25;8:10. doi: 10.1186/1477-7525-8-10. PMID 20100332
- BACKGROUNDBasch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. PMID 26644527
- BACKGROUNDKroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240-8. doi: 10.1001/jama.2014.7689. PMID 25027139
- BACKGROUNDBasch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.