Collaborative cOMMUNIty Care for Metastatic breAsT cancEr Patients in inDonesia (Communicated)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGadjah Mada University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Health education for cadre (communicated project)
Other interventionThe 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Health education for cadreExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
2-3 monthsSecondary outcomes
1
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.
Time frame
2-3 months2
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).
Time frame
2-3 months3
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.
Time frame
2-3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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