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

NCT ID: NCT06517992

Condition: Metastatic Breast Cancer
Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Cadre
Education
Community empowerment
Indonesia
Metastatic Breast Cancer

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Quasi experiment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Health education for cadre (communicated project)
Description: The investigators perform health education to cadre in order to support their role in providing care for metastatic breast cancer living in the community using a module. The module consists of text (written information) and some videos as education medias.
Arm group label: Health education for cadre

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria for mBC: - Diagnosed for having breast cancer at least in stage 3B or confirm to have metastatic breast cancer - Live at home - Considered as adult (Eighteen years of age or older) Exclusion Criteria for mBC: - mBC patients will be exclude when their physical condition is deteriorating or when they need hospitalization. The following criteria will be applied for family caregivers: 1. Appointed by mBC patients or self-identified as family caregiver of mBC patients for at least 3 months 2. Live/not live together with mBC patients but providing care to mBC patient 3. Considered as adult (Eighteen years of age or older) Inclusion criteria for cadre: The local cadre in Yogyakarta and Bali who self-identified as local cadre in the community and willing to involve for assisting mBC patients. The local cadre will be excluded when they are not providing consent to involve in the current study.

Gender: All

Gender based: Yes

Gender description: Female metastatic Breast cancer

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Primary Health Center

Address:
City: Yogyakarta
Zip: 55581
Country: Indonesia

Facility:
Name: Primary Health center

Address:
City: Bali
Country: Indonesia

Contact:
Last name: I Made Cahyadi, MSN

Phone: +6285792100989
Email: cahyadiagastiya@mail.ugm.ac.id

Start date: September 1, 2024

Completion date: September 1, 2025

Lead sponsor:
Agency: Gadjah Mada University
Agency class: Other

Collaborator:
Agency: Pfizer
Agency class: Industry

Collaborator:
Agency: Queensland University of Technology
Agency class: Other

Source: Gadjah Mada University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06517992
https://doi.org/10.1016/j.enfcli.2020.06.056
https://peraturan.bpk.go.id/Details/111722/permenkes-no-8-tahun-2019
https://jurnal.stikespantiwaluya.ac.id/index.php/JPW/article/view/63

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