Plain English Summary
Background and study aims
There has been limited research on Islamic caring mindfulness-based program for enhancing spiritual well-being and fatigue for women with advanced breast cancer in Indonesia. Since spiritual practice including mindfulness practice through prayer and dhikr meditation are part of Muslims’ daily life practice, therefore, it is feasible and worth promoting this program.
The aim of this study was to evaluate the effects of the Islamic caring mindfulness-based program on spiritual well-being and fatigue on Indonesian women with advanced breast cancer undergoing chemotherapy.
Who can participate?
All Muslim patients with advanced breast cancer either new or recurrent cases that came for chemotherapy treatment were the target for this study.
What does the study involve?
A program based on Islamic philosophy (the True Faith and the Five Pillars) for enhancing spiritual well-being and alleviating the fatigue of Indonesian women with advanced breast cancer undergoing chemotherapy. The program follows the standard care during chemotherapy with the adjunct of specific ICMB activities attached, namely, Islamic prayer, breath dzikr meditation, and Islamic caring. The duration of the program was six weeks.
What are the possible benefits and risks of participating?
By becoming a participant, the participants will get knowledge about breast cancer, the side effects of chemotherapy and its management, as well as get information about how to do prayer and dhikr meditation properly, so that it is beneficial for health. In addition, the program did not have a negative side effect.
Where is the study run from?
The chemotherapy unit at the Teaching Hospital, Bandung West Java Province, Indonesia
When is the study starting and how long is it expected to run for?
January 2018 to July 2018
Who is funding the study?
Graduate School, Prince of Songkla University, Thailand
Who is the main contact?
Maria Komariah
maria.komariah@unpad.ac.id
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Maria Komariah
ORCID ID
http://orcid.org/0000-0003-1648-4882
Contact details
Bumi Panyileukan Citra culdesac No. 12
A RT/RW 004/013 Kel. Cipadung Kidul
Panyileukan
Soekarno Hattha
Bandung
40614
Indonesia
+62227795596/+6289611556007
maria.komariah@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Islamic caring mindfulness-based program on spiritual well-being and fatigue in Indonesian women with advanced breast cancer
Acronym
ICMB
Study hypothesis
1. The mean scores of the intervention group on days 2-3 (Time-2), on days 23-24 (Time-3), and days 44-45 (Time-4) will be higher than those of the control group.
2. The mean scores of fatigue of the intervention group after receiving the program on days 2-3 (Time-2), on days 23-24 (Time-3), and day 44-45 (Time-4) will be higher than those of the control group.
3. The mean scores of spiritual well-being of the intervention group after receiving the program on days 2-3 (Time-2), on days 23-24 (Time-3), and days 44-45 (Time-4) will be higher than at baseline.
4. The mean scores of fatigue of the intervention group after receiving the program on days 2-3 (Time-2), on days 23-24 (Time-3), and days 44-45 (Time-4) will be higher than at baseline.
Ethics approval
Approved 15/01/2018, The Institutional Review Board of the Faculty of Nursing (Center for Social and Behavioral Sciences, Institutional Review Board, Faculty of Nursing, Prince of Songkla University, 15 Karnjanavanich Road, Hat Yai, Songkla 90110, Thailand; +66 74 286 422; sasitorn.ph@psu.ac.id), ref:2017 NSt-Qn 054
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Advanced breast cancer undergoing chemotherapy
Intervention
This nursing intervention program refers to a program based on Islamic philosophy (the True Faith and the Five Pillars) for enhancing spiritual well-being and alleviating fatigue of Indonesian women with advanced breast cancer undergoing chemotherapy. The program follows the standard care during chemotherapy with the adjunct of specific ICMB activities attached, namely, Islamic prayer, breath dzikr meditation, and Islamic caring. The duration of the program was six weeks.
The researcher assigned randomly the eligible participants by using the software i.e. the minimized randomization software (version 2.01) into two intervention arms.
First Group (experimental group) was given ICMB program
Second Group (control group) was given usual care
Contents of ICMB program session:
Provision of knowledge about the disease and complications (i.e., what is the breast cancer, stages of breast cancer, causes and risk factors, treatment and its side effect, symptoms management).
Training, coaching & practicing prayer and breath dzikr meditation (i.e., what Quran says about prayer and dzikr meditation, benefits of prayer and dzikr meditation, how to perform prayer and dzikr meditation, how prayer and dzikr meditation is useful for advanced breast cancer)
Reflection
Preparation (15 min):
-Forming a caring relationship by greeting, touching, respecting and blessing in Islamic way.
-Praying together for healing and asking help from Allah.
-Encouraging the patient and the families to be patient with the illness
Individual practice(the participants):
-Prayer (10 min)
-Breath dzikr meditation (30 min)
-Reflection (5 min)
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Spiritual well-being measured using the Functional Assessment of Chronic Illness Therapy (Spiritual) (FACIT-Sp) at baseline (Time-1), on day 3-4 (Time-2), on day 23-24 (Time-3), and day 44-45 (Time-4)
2. Fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT- Fatigue) at baseline (Time-1), on day 3-4 (Time-2), on day 23-24 (Time-3), and day 44-45 (Time-4)
Secondary outcome measures
level of Islamic mindfulness (khushu prayer) measured using the Khushu Prayer Questionnaire, at baseline
Overall trial start date
17/01/2018
Overall trial end date
03/07/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Muslim
2. Aged over 18 years
3. Diagnosis of stage III breast cancer
4. Can perform basic daily activities with the Eastern Cooperative Oncology Group (ECOG) with a Performance Score of 0 – 2, 0 refers to fully active, no performance restrictions, 2 refers to able to carry out all self-care but incapable to perform any work activities, up and about >50% of waking hours, it was important for screening the patient’s ability to perform prayer perfectly
5. Cognitively intact and without a documented diagnosis of mental illness
6. Speak and understand Bahasa Indonesian
7. Access to a telephone
8) Received chemotherapy treatments every 21 days at any cycle ≤ 4 cycles including the current cycle
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
1. Regularly used complementary alternative medicine (e.g., reflexology, foot massage, pedicure with massage)
2. Could not completely follow the program
Recruitment start date
17/01/2018
Recruitment end date
03/05/2018
Locations
Countries of recruitment
Indonesia
Trial participating centre
Bandung Teaching Hospital
Jl. Pasteur No. 38
Bandung
-
Indonesia
Sponsor information
Organisation
Universitas Padjadjaran
Sponsor details
Jl Raya Bandung-Sumedang KM 21
Jatinangor
Sumedang
West Java
Bandung
40614
Indonesia
+62227795596/+6289611556007
maria.komariah@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Graduate School, Prince of Songkla University, Thailand
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Current publication and dissemination plan as of 19/03/2020:
Opcion
Previous publication and dissemination plan:
Nursing & Health Sciences journal
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
05/09/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list