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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13311651
Enrollment
30
Registered
2024-03-11
Start date
2023-10-10
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological cancer survivors on chemotherapy Cancer

Interventions

Tele-coaching and tele-education: the FoRSHE-X intervention consists of 10 weeks of social media-based education and telecoaching.

Sponsors

University of Indonesia
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

Indonesia

Contacts

Public ContactDyah Juliastuti
dyah_ja@universitasichsansatya.ac.id+62 (0)852 1805 2224

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026