A Novel mHealth Approach to Assess and Manage Palliative Care Needs for Cancer Patients in Kigali

NCT03367637 | Withdrawn

• 1 other identifier: 2017P002380
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer Pain

Keywords

Cancer Pain, Palliative care, Mobile Applications, Rwanda

Outcome Measures

Primary Outcomes (1)

• Difference in pain score as measured by the expanded African Palliative Care Outcomes Scale (APCA POS)

  Pain score will be assessed on a scale 1(no pain)-5 (worst/overwhelming pain) in both arms and the mean difference in pain score between two arms will be calculated.

  6 weeks, 3 months

Secondary Outcomes (1)

• Difference in other symptoms and quality of life (QOL) scores from the remaining portion of the expanded APCA POS individually and as composite score.

  6 weeks, 3 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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.

Other: Standard palliative care

Intervention

EXPERIMENTAL

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.

Other: Smart Phone based symptom evaluation application

Interventions

Standard palliative care OTHER

Standard care includes regular follow-up phone calls and home visits by the RPCHO staff for all advanced cancer patients at RPCHO, 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. For after-hours emergency assistance, patients have the option of contacting the on-call palliative-care physicians for assistance.

Standard Care

Smart Phone based symptom evaluation application OTHER

In addition to the standard palliative care currently provided at the RPCHO, patients will receive biweekly reminders to fill out the African Palliative Care Outcomes Scale (APCA POS) on the new smartphone application on their phones. It is a short symptom assessment questionnaire with responses on 5-point severity scale. In addition to bi-weekly frequency, 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Rwanda Palliative Care and Hospice Organization: collaborator
• University of California, San Francisco: collaborator
• Cornell Tech: collaborator
• King's College London: collaborator

Study Sites (1)

Rwanda Palliative Care and Hospice Organization (RPCHO)

Kigali, Rwanda

Location

Related Publications (8)

• Ntizimira CR, Nkurikiyimfura JL, Mukeshimana O, Ngizwenayo S, Mukasahaha D, Clancy C. Palliative care in Africa: a global challenge. Ecancermedicalscience. 2014 Dec 11;8:493. doi: 10.3332/ecancer.2014.493. eCollection 2014.

  PMID: 25624874 BACKGROUND

• Sepulveda C, Habiyambere V, Amandua J, Borok M, Kikule E, Mudanga B, Ngoma T, Solomon B. Quality care at the end of life in Africa. BMJ. 2003 Jul 26;327(7408):209-13. doi: 10.1136/bmj.327.7408.209.

  PMID: 12881267 BACKGROUND

• Clark D, Wright M, Hunt J, Lynch T. Hospice and palliative care development in Africa: a multi-method review of services and experiences. J Pain Symptom Manage. 2007 Jun;33(6):698-710. doi: 10.1016/j.jpainsymman.2006.09.033.

  PMID: 17531910 BACKGROUND

• Harding 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 BACKGROUND

• Basch 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 BACKGROUND

• Kroenke 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 BACKGROUND

• Basch 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.

  PMID: 28586821 BACKGROUND

• Agboola S, Kamdar M, Flanagan C, Searl M, Traeger L, Kvedar J, Jethwani K. Pain management in cancer patients using a mobile app: study design of a randomized controlled trial. JMIR Res Protoc. 2014 Dec 12;3(4):e76. doi: 10.2196/resprot.3957.

  PMID: 25500281 BACKGROUND

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aparna Parikh, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We will enroll 80 advanced cancer patients with moderate to severe pain needs (10 per month) with estimated 40% females. Following informed consent, study staff will administer baseline assessments, assess eligibility and obtain consent. Subsequently, eligible consenting patients, will be randomly assigned via computer-generated randomization, to standard palliative care (currently provided at Rwanda Palliative Care and Hospice Organization) or to the new smartphone intervention (with biweekly and SOS symptom assessment and response) plus standard care for 3 months. The probability of being assigned to either group will be equal (50%). With 36 patients per group, we will have 85% power to detect a clinically significant difference of 1 point on the pain score \[SD=1.4\] between the two treatment groups at 3-months with an alpha of 0.05. Based on prior studies and assuming an attrition rate of no more than 10%, we increased our sample size to 40 patients per group.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: January 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)