FoRSHE-X digital health intervention to improve quality of life during chemotherapy among gynecological cancer survivors in Indonesia: pilot and feasibility study

ISRCTN	ISRCTN13311651
DOI	https://doi.org/10.1186/ISRCTN13311651
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	NKB-343/UN2.RST/HKP.05.00/2023
Sponsor	University of Indonesia
Funder	Direktorat Riset and Pengembangan, Universitas Indonesia

Submission date: 29/02/2024
Registration date: 11/03/2024
Last edited: 19/12/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
It is estimated that ten million cancer-related deaths occurred in 2020. Low- and middle-income countries (LMICs) have a higher burden of cancer with more than 70% cancer-related fatalities. In the case of cervical cancer, the disparity is even more prominent, as 90% of new cases and deaths happened in LMICs. Given the immense cancer concerns in many LMICs, reducing premature death through promoting well-being has been listed as one of the targets of the Sustainable Development Goals (SDG). It is crucial to increase the country's capacity to provide quality care across the cancer care continuum, including survivorship care. As most Indonesian gynecological cancer survivors have unmet supportive care needs which may lower their quality of life and discontinue the treatment, digital interventions can solve cancer survivors' unmet needs for health information and physical and psychosocial support during chemotherapy. Digital health interventions can enhance communication between cancer patients and healthcare providers. Therefore, this study aims to (1) examine the feasibility and acceptability of a Fighting on distRess, Self-efficacy, Health Effects, and seXual issues (FoRSHE-X) intervention, and to (2) evaluate the impact of the study implementation on the level of distress, self-efficacy, side effects’ knowledge and management, and sexual quality of life.

Who can participate?
Women, aged 18 years old or older, diagnosed with gynecological cancer undergoing chemotherapy in the Dharmais National Cancer Centre (DNCC), Jakarta, Indonesia, who are willing to participate in the FoRSHE-X intervention consisting of 10 weeks of social media-based education and tele-coaching program.

What does the study involve?
The researchers invite potential participants to be involved in this study while they are at the outpatient clinic or in the chemotherapy ward. If they fulfil the eligibility criteria to be part of this study, they are included in the information session at the DNC or through a Zoom meeting, in which they complete the online questionnaires and receive an explanation about the social-media educational product (uploaded to the project Instagram and YouTube channel) and how tele-education and tele-coaching are performed in the next 10 weeks. After that, the participants attend individual tele-education and tele-coaching programs every week through Zoom or WhatsApp meetings in line with their chemotherapy program. In the middle and at the end of the study period, the participants re-complete the questionnaire and interview for study continuity and acceptability.

What are the possible benefits and risks of participating?
The study will support and accompany the participants to pass through the challenging chemotherapy time. It is expected that with adequate support all the participants can accomplish their cancer therapy. Moreover, the participants will receive an internet data plan worth IDR 100,000 per month for the 2.5-month duration of the research activities. They will also receive a compensation of IDR 100,000 at the end of the FoRSHE-X digital intervention to offset the time spent participating in this study. The participants who will also be interviewed after the provision of digital education and tele-coaching will receive IDR 100,000 as compensation for transportation and time used during the interview process.

Where is the study run from?
1. Universitas Indonesia (Indonesia)
2. Dharmais National Cancer Centre (DNCC) (Indonesia)

When is the study starting and how long is it expected to run for?
March 2023 to December 2024

Who is funding the study?
Direktorat Riset and Pengembangan, Universitas Indonesia (Grant number: NKB-343/UN2.RST/HKP.05.00/2023) (Indonesia)

Who is the main contact?
1. Prof. Dr. Yati Afiyanti, yatikris@ui.ac.id
2. Dr Dyah Juliastuti, dyah_ja@universitasichsansatya.ac.id

Contact information

Prof Yati Afiyanti
Principal investigator

Faculty of Nursing
Universitas Indonesia
Depok
16424
Indonesia

ORCID ID	0000-0001-9382-6714
Phone	+62 (0)813 1549 3320
Email	yatikris@ui.ac.id

Dr Dyah Juliastuti
Public, Scientific

Program Study of Nursing
Faculty of Health Sciences
Universitas Ichsan Satya
Tangerang Selatan
15414
Indonesia

ORCID ID	0000-0002-4159-9166
Phone	+62 (0)852 1805 2224
Email	dyah_ja@universitasichsansatya.ac.id

Study information

Primary study design	Interventional
Study design	Non-randomized mixed-methods (quasi-experimental single-group pretest-posttest design and semi-structured interview qualitative study)
Secondary study design	Semi-structured interview qualitative phenomenology study
Participant information sheet	45110_PIS.pdf
Scientific title	The development of FoRSHE-X digital intervention (education and tele-coaching) to improve the quality of life of gynecological cancer patients: pilot and feasibility study
Study acronym	FoRSHE-X
Study objectives	The primary objectives are as follows 1. To examine the eligibility and acceptability of the participants towards the study intervention 2. To evaluate the feasibility of digital education, telecoaching, and intervention facilitators 3. To evaluate the process of the implementation 4. To evaluate the intervention sustainability or participants’ involvement over time The secondary objective is to evaluate the effectiveness of the study intervention on the participants': 1. Level of anxiety 2. Self-efficacy 3. Side effects’ knowledge and management 4. Sexual quality of life
Ethics approval(s)	1. Approved 08/08/2023, The Committee of the Medical Research Ethics of the Dharmais Cancer Hospital (Jalan Letjen S. Parman Kav. 84-86, Slipi, Jakarta, 11420, Indonesia; +62 (0)21 5681570; dharmais@dharmais.co.id), ref: 259/KEPK/VIII/2023 2. Approved 23/05/2023, FIK UI (Faculty of Nursing, Universitas Indonesia) Ethics Committee (UI campus, Depok, 16424, Indonesia; +62 (0)21 788 49 120; publicrelation-nursing@ui.ac.id), ref: KET-136/UN2.F12.D1.2.1/PPM.00.02/2023
Health condition(s) or problem(s) studied	Gynecological cancer survivors on chemotherapy
Intervention	Tele-coaching and tele-education: the FoRSHE-X intervention consists of 10 weeks of social media-based education and telecoaching.
Intervention type	Behavioural
Primary outcome measure(s)	1. Recruitment rate: the number of eligible/potential participants who accept the invitation to participate in the study and sign the consent to participate in the study for at least a 10-week period. 2. Response rate: the participants’ complete responses to the questionnaire at baseline or pre-intervention time (T0), in the middle of the intervention period or at the end of working phase I (T1) and at the end of working phase II or at the end of the overall study period (T2). 3. Participation rate: the number of participant attendances in social-media educational and tele-coaching activities over the 10-week period. 4. Facilitators’ satisfaction and barriers were explored using semi-structured interviews at the end of the study period or after all digital health interventions were delivered to the participants. 5. Participant satisfaction rates measured using a study instrument adapted from the Telehealth Satisfaction Survey by AHRQ, U.S. Department of Health & Human Services at the end of the 10-week study period of telehealth interventions. 6. Attrition rate analyzed as the rate of participant retention till the end of the 10-week study period. 7. Qualitatively, participants will be interviewed for their perspectives on intervention adherence, barriers, and acceptability of the recruitment processes, intervention design, and outcome measurements at the end of the study.
Key secondary outcome measure(s)	1. Sociodemographic data of the participants (i.e. age, education, marital status, employment, ethnicity, and religious affiliation) and clinical data (i.e. gynecological cancer type and stage, and cancer treatment details) assessed at the beginning of the study period. 2. Distress measured using a Distress Thermometer from the NCCN Distress Management Panel at baseline or pre-intervention time (T0), in the middle of the intervention period or at the end of working phase I (T1) and at the end of working phase II or at the end of the overall study period (T2). 3. Knowledge and practice regarding chemotherapy side effects are measured using the chemotherapy side effect questionnaire, outlined by Almohammadi, et al. (2020), at baseline or pre-intervention time (T0), in the middle of the intervention period or at the end of working phase I (T1) and at the end of working phase II or at the end of the overall study period (T2). 4. Self-efficacy is measured using the self-efficacy for managing chronic disease 6-item scale (SEMCD6) initially developed by the Stanford Patient Education Research Center at baseline or pre-intervention time (T0), in the middle of the intervention period or at the end of working phase I (T1) and at the end of working phase II or at the end of the overall study period (T2). 5. Sexual quality of life (SQoL-F) is measured using Sexual Quality of Life-Female (SQOL-F) at baseline or pre-intervention time (T0), in the middle of the intervention period or at the end of working phase I (T1) and at the end of working phase II or at the end of the overall study period (T2).
Completion date	31/12/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	30
Total final enrolment	19
Key inclusion criteria	1. Female aged 18 years or older 2. Being diagnosed with gynecological cancer (including cervical, ovarian, uterine, vulvar, vaginal, and fallopian tube cancer) 3. Receiving chemotherapy at the DNCC 4. Having a smartphone 5. Willing and physically or cognitively able to participate in the study and follow the study procedures 6. Being able to communicate in Bahasa Indonesia
Key exclusion criteria	Patients diagnosed with severe neurological conditions such as unmanaged mental health diagnosis, current metastases to the brain, delirium, and dementia, as well as those with any prior history of receiving chemotherapy or cancer recurrence.
Date of first enrolment	10/10/2023
Date of final enrolment	09/06/2024

Locations

Countries of recruitment

Indonesia

Study participating centre

Dharmais Cancer Hospital

Jl. Letjen S. Parman Kav. 84-86 Slipi
Jakarta
11420
Indonesia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
IPD sharing plan	Not available, unless anonymous data inside the publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		18/12/2024	19/12/2024	Yes	No
Participant information sheet			08/03/2024	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol (preprint)		22/02/2024	08/03/2024	No	No

Additional files

45110_PIS.pdf: Participant information sheet

Editorial Notes

19/12/2024: Publication reference added.
19/06/2024: Total final enrolment added.
04/04/2024: The following changes were made:
1. The recruitment end date was changed from 09/04/2024 to 09/06/2024.
2. The intention to publish date was changed from 01/04/2024 to 01/08/2024.
29/02/2024: Study's existence confirmed by the University of Indonesia.