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

NCT06517992 | Not Yet Recruiting

• 1 other identifier: Communicated UGM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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).

Conditions

Metastatic Breast Cancer; Cancer

Keywords

Cadre; Education; Community empowerment; Indonesia; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2-3 months

Secondary Outcomes (3)

• Symptom Management Self Efficacy Scale - Breast Cancer (SMSES-BC)

  2-3 months

• Preparedness for caregiving scale (PCS)

  2-3 months

• Resilience Scale Specific to Cancer (RS-SC-10)

  2-3 months

Study Arms (1)

Health education for cadre

EXPERIMENTAL

Health education for cadre (Health Community Volunteer) to support metastatic breast cancer patients and their family caregivers

Other: Health education for cadre (communicated project)

Interventions

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.

Health education for cadre

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female metastatic Breast cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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)
• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead
• Pfizer: collaborator
• Queensland University of Technology: collaborator

Study Sites (2)

Primary Health Center

Yogyakarta, Special Region of Yogyakarta, 55581, Indonesia

Location

Primary Health center

Bali, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 30916614 RESULT

• Kristanti 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.

  PMID: 28095837 RESULT

Related Links

• 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.
• Permenkes. Peraturan Menteri Kesehatan Republik Indonesia Nomor 8 Tahun 2019 Tentang Pemberdayaan Masyarakat Bidang Kesehatan. 2019.
• Sunarti. peran kader kesehatan dalam pelayanan posyandu UPTD puskesmas kecamatan sananwetan kota Blitar. Jurnal Keperawatan Malang 2019; 3: 94-100.

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Syahirul Alim, PhD

  Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada

  STUDY CHAIR

Central Study Contacts

Martina Sinta Kristanti, PhD

CONTACT

+6281227811976; sinta@ugm.ac.id

Lalitya Paramarta, BSN

CONTACT

+6285647152142; lalitya.paramarta@mail.ugm.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Quasi experiment

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)