Condition category
Cancer
Date applied
24/08/2019
Date assigned
11/09/2019
Last edited
09/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

05/09/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/09/2019: Trial’s existence confirmed by The Institutional Review Board of the Faculty of Nursing (Prince of Songkhla University, Thailand)