Metastatic Breast CancerCommunicatedNCT06517992
Collaborative cOMMUNIty Care for Metastatic breAsT cancEr Patients in inDonesia (Communicated)
A study testing Health education for cadre (communicated project) in people with Metastatic Breast Cancer and Cancer, run by Gadjah Mada University at 2 sites in Indonesia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metastatic Breast Cancer, Cancer
- What is being tested?
- Health education for cadre (communicated project)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- 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.
Who cannot join
- 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:
- Appointed by mBC patients or self-identified as family caregiver of mBC patients for at least 3 months
- Live/not live together with mBC patients but providing care to mBC patient
- Considered as adult (Eighteen years of age or older)
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Primary Health center
Bali
I Made Cahyadi, MSN, +6285792100989, cahyadiagastiya@mail.ugm.ac.id
Primary Health Center
Yogyakarta, Special Region of Yogyakarta, 55581
About this study
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).
Read the 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.
- Conditions
- Metastatic Breast Cancer, Cancer
- Being tested
- Health education for cadre (communicated project)
- Keywords
- Cadre, Education, Community empowerment, Indonesia, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education for cadre (communicated project)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Health education for cadre | Experimental | Health education for cadre (Health Community Volunteer) to support metastatic breast cancer patients and their family caregivers Receives: Other: Health education for cadre (communicated project) |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organization for Research and Treatment for Cancer Quality of Life Questionnaire - Breast Cancer (EORTC QLQ-BR23)
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.
Measured: 2-3 months
Secondary outcomes (3)
Symptom Management Self Efficacy Scale - Breast Cancer (SMSES-BC)
This instrument consists of 27 items related to self-efficacy in the symptom management relevant to chemotherapy for patients with breast cancer. The items is offering rating from 0 not at all confident) to 10 (completely confident). The higher score represents higher perceived of symptom-management self-efficacy.
Measured: 2-3 months
Preparedness for caregiving scale (PCS)
PCS consists of 8 items and 1 open ended question. This is a family caregiver instrument to self-rated how well are of becoming caregivers with the domain of providing physical care, emotional support, setting up in-home support services and dealing with caregiver's stress. Responses are ranging from 0 (not at all prepared) to 5 (very well prepared).
Measured: 2-3 months
Resilience Scale Specific to Cancer (RS-SC-10)
tThis instrument is a brief and validated instrument for family caregivers of patient with cancer [44] which consists of 10 items. RS-SC developed using MRIT analysis and consists of 2 domains: generic and Shift-Persist. The score ranges from 10-50 with the higher score represents higher resilience.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi experiment
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Queensland University of Technology
- Responsible party
- Principal investigator, Martina Sinta Kristanti, Gadjah Mada University
- Investigators
- Syahirul Alim, PhD, Study chair, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517992
- Sponsor's protocol ID
- Communicated UGM
- Acronym
- Communicated
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kristanti MS, Effendy C, Utarini A, Vernooij-Dassen M, Engels Y. The experience of family caregivers of patients with cancer in an Asian country: A grounded theory approach. Palliat Med. 2019 Jun;33(6):676-684. doi: 10.1177/0269216319833260. Epub 2019 Mar 27.
PubMed 30916614Kristanti MS, Setiyarini S, Effendy C. Enhancing the quality of life for palliative care cancer patients in Indonesia through family caregivers: a pilot study of basic skills training. BMC Palliat Care. 2017 Jan 17;16(1):4. doi: 10.1186/s12904-016-0178-4.
PubMed 28095837
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative cOMMUNIty Care for Metastatic breAsT cancEr Patients in inDonesia (Communicated)
- ClinicalTrials.gov ID
- NCT06517992
- Acronym / sponsor ID
- Communicated / Communicated UGM
- Conditions
- Metastatic Breast Cancer, Cancer
- Keywords
- Cadre, Education, Community empowerment, Indonesia, Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- Pfizer, Queensland University of Technology
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi experiment
| Arm | Type | Receives |
|---|---|---|
| Health education for cadre | Experimental | Other: Health education for cadre (communicated project)Health education for cadre (Health Community Volunteer) to support metastatic breast cancer patients and their family caregivers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- 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.
Key exclusion criteria (5 listed)
- mBC patients will be exclude when their physical condition is deteriorating or when they need hospitalization.
- Appointed by mBC patients or self-identified as family caregiver of mBC patients for at least 3 months
- Live/not live together with mBC patients but providing care to mBC patient
- Considered as adult (Eighteen years of age or older)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education for cadre (communicated project)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. | Other | Health education for cadre |
Primary outcome
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.
3 secondary outcomes
Symptom Management Self Efficacy Scale - Breast Cancer (SMSES-BC)
Time frame: 2-3 months
Preparedness for caregiving scale (PCS)
Time frame: 2-3 months
Resilience Scale Specific to Cancer (RS-SC-10)
Time frame: 2-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Results publication: PubMed 30916614Kristanti MS, Effendy C, Utarini A, Vernooij-Dassen M, Engels Y. The experience of family caregivers of patients with cancer in an Asian country: A grounded theory approach. Palliat Med. 2019 Jun;33(6):676-684. doi: 10.1177/0269216319833260. Epub 2019 Mar 27.
- Results publication: PubMed 28095837Kristanti MS, Setiyarini S, Effendy C. Enhancing the quality of life for palliative care cancer patients in Indonesia through family caregivers: a pilot study of basic skills training. BMC Palliat Care. 2017 Jan 17;16(1):4. doi: 10.1186/s12904-016-0178-4.
- Sapar, Salju, Risal M, et al. The influence of TB care community cadre's roles on the treatment adherence of tuberculosis (TB) sufferers. Enfermería Clínica 2020; 30: 244-248.Link provided by the sponsor.
- Permenkes. Peraturan Menteri Kesehatan Republik Indonesia Nomor 8 Tahun 2019 Tentang Pemberdayaan Masyarakat Bidang Kesehatan. 2019.Link provided by the sponsor.
- Sunarti. peran kader kesehatan dalam pelayanan posyandu UPTD puskesmas kecamatan sananwetan kota Blitar. Jurnal Keperawatan Malang 2019; 3: 94-100.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syahirul Alim, PhD study chair
Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education for cadre (communicated project) in people with Metastatic Breast Cancer and Cancer, run by Gadjah Mada University at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Sinta Kristanti, PhD (+6281227811976, sinta@ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for Research and Treatment for Cancer Quality of Life Questionnaire - Breast Cancer (EORTC QLQ-BR23) (time frame: 2-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06517992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.