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Clinical Trials/NCT06517992
NCT06517992
Not yet recruiting
Not Applicable

Collaborative cOMMUNIty Care for Metastatic breAsT cancEr Patients in inDonesia (Communicated)

Gadjah Mada University2 sites in 1 country80 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Breast Cancer
Sponsor
Gadjah Mada University
Enrollment
80
Locations
2
Primary Endpoint
European Organization for Research and Treatment for Cancer Quality of Life Questionnaire - Breast Cancer (EORTC QLQ-BR23)
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The current study aims to empower local cadres in providing care for metastatic breast cancer (mBC) patients in 2 provinces in Indonesia (Bali and Yogyakarta).

Detailed Description

Most mBC patients in Indonesia stay at home until they have heavy physical symptoms and need hospitalizations. In this country, even in hospitalization, support from the family caregivers is greatly needed \[1\]. Family caregivers and the community have a significant role for patients with mBC. In Indonesia, the support system from local neighbours and community has been implemented for some decades through the involvement of cadres. Health cadres are people from the village who are appointed by their community to train and enhance the community participation in order to empower community health in Indonesia \[2\]. Most of them are housewives who have enough capability (mentally and physically) to learn, have enough time, and willing to provide support for their community. This role is informal and voluntary-based \[3\]. -Community support through the existence of cadre in Indonesia- Cadres in Indonesia are initiated by community health services (hereafter Pusat Kesehatan Masyarakat/Puskesmas) around the area. The selection and development of cadres involve the lowest level of local government in the area. Cadres need to have some essential characteristics to undertake their role. They should have empathy as well as good communication skills since one of their tasks is to deliver important health information and message to the community. They need to be able to connect with the community to develop a mutual understanding and be accepted \[4\]. Funding received from national and local government is allocated for cadres to subsidize the transportation and logistics expenses, but this does not cover the monthly wages \[2\]. Cadres play a fundamental role in tackling health care problems especially those that are related to psychosocial and cultural factors since they have enough information and knowledge about people and situations in their area. Health care professionals who work in Puskesmas usually cooperate with cadres to gather information related to health conditions in the area or to support local activities. Several roles of cadre have been identified. First, health cadres are responsible for educating and motivating patients and their family to access health care system. They are responsible for assisting patients to access health care facilities for early diagnosis or treatment. On a daily basis, cadres are expected to monitor patients' condition as well as do home visit. At last, it is expected that cadres are able to advocate for patients and their family in the relation to health care professionals \[5, 6\]. Cadres are initiated and developed by Puskesmas and working closely with integrated health service posts (hereafter Posyandu). Posyandu is a local health unit, under the coordination of Puskesmas, that aims to provide care for baby and infant. Their activities include baby weighting, providing vitamin and enhancing the nutritional status of babies and infants. During Posyandu, health care teams from Puskesmas and cadres are working together. To be able to be classified as active, a Posyandu needs to have at least five health cadres \[2\]. Currently, there are around 395.495 health cadres in Indonesia. -Challenges of cadre in Indonesia- In Indonesia, some challenges faced by cadres have been identified. The first is that the role of cadres in Indonesia is still limited. Mostly, their role is merely to provide care for infants and children. Since the number of mBC patients who stay at home is high, health cadres are frequently requested to provide care for this specific group. There have been several initiatives in Indonesia focused on expanding cadres' roles; however, most of the initiatives are focusing on screening and early detection of cancer \[7-9\]. Until now, there is no single adequate intervention in Indonesia to prepare cadres in Indonesia to support mBC patients and their family caregivers. The second issue is that although cadres have some connections with Puskesmas, the breadth and depth of the connections are still limited and have an unclear structure. There is a need to open communication channels so that cadres are able to connect with health care professionals from Puskesmas and their role can be recognized by local health authorities. When needed, cadres would be better positioned to request for help or provide important information to Puskesmas in regards to mBC patients problems and needs. Given the important role of cadres, the COMMUNICATED project aims to empower local cadres to provide care for metastatic breast cancer (mBC) patients in in Indonesia.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
September 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Gadjah Mada University
Responsible Party
Principal Investigator
Principal Investigator

Martina Sinta Kristanti

Principal Investigator

Gadjah Mada University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

European Organization for Research and Treatment for Cancer Quality of Life Questionnaire - Breast Cancer (EORTC QLQ-BR23)

Time Frame: 2-3 months

Questionnaire to measure Quality of Life of Breast Cancer Patients. This consists of 23 items with 2 domains: symptom scales (systemic therapy side effects, upset by hair loss, Arm symptoms and Breast symptoms) and functional scale (body image, future perspective, sexual functioning, and sexual enjoyment). The questionnaire uses likert scale 1-4. The options are not at all, a little, quite a bit, and very much. An option for "Not applicable (N/A)" is also offered for an item of sexual enjoyment. This instrument has been translated to Bahasa Indonesia. The scale ranges in score from 0-100 with a higher score for the functional scale represents a high or healthy level of functioning. On the other hand, the high score for symptom scale represents frequent problems.

Secondary Outcomes

  • Preparedness for caregiving scale (PCS)(2-3 months)
  • Resilience Scale Specific to Cancer (RS-SC-10)(2-3 months)
  • Symptom Management Self Efficacy Scale - Breast Cancer (SMSES-BC)(2-3 months)

Study Sites (2)

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