The goal of this randomized controlled trial is to evaluate the effectiveness of a digital psychoeducational intervention for young adults experiencing fertility-related distress following a cancer diagnosis. It will also assess how the intervention supports the development of effective coping strategies and social support networks. The main questions it aims to answer are: Does the digital psychoeducational intervention reduce anxiety and depression severity compared with usual care? Does the digital psychoeducational intervention increase patients' self-efficacy, social support, and coping compared with usual care? Does the digital psychoeducational intervention increase patients' quality of life compared with usual care? Researchers will compare the digital psychoeducational intervention to usual care (standard treatment) to see if the intervention effectively manages psychological problems and improves quality of life. Participants will:Be randomly assigned to either the experimental group or the control group. Attend an initial face-to-face introductory session, followed by four digital psychoeducational modules delivered via a mobile phone application (if assigned to the experimental group). Engage with module content including an e-booklet, video, and quizzes, with a new module opening every two days. Receive standard treatment from healthcare providers, and later receive the psychoeducational materials at the end of the data collection period (if assigned to the control group). Complete a series of validated questionnaires measuring depression, anxiety, coping, self-efficacy, social support, and quality of life at four different time points throughout the study.
Diagnosed with cancer.
Self-report fertility-related distress.
Aged 18 to 40 years old.
Able to speak Bahasa (the national language of Indonesia).
Have a severe medical condition which impacts their level of consciousness.
Diagnosed with a major psychiatric comorbidity.
Unable to fill out the study questionnaires.
Unable to decide to participate due to cognitive impairment, decreasing consciousness level, or difficulty verbalizing their wishes.
Parallel
Digital psychoeducational intervention
BehavioralThe intervention is a guided digital psychoeducational program that begins with a face-to-face introductory session. Participants then use a specialized mobile application to complete four sequential thematic modules: Cancer and Fertility, Development of Coping Skills, Self-Efficacy, and Social Support. Each module features an e-booklet, a video, and interactive quizzes. To encourage the active practice of learned skills, the modules are time-locked, requiring a two-day interval before the next module becomes accessible. The application uniquely includes automated motivational messaging, customizable daily reminders, and a direct messaging portal connecting patients to a counselor. Additionally, study staff conduct a follow-up phone call two weeks after the introductory session to troubleshoot technical issues, monitor progress, and reinforce the practical application of the new coping and social support skills.
control group (standard of care + placebo).
BehavioralParticipants assigned to the control group will receive standard care from their healthcare providers, which typically involves brief explanations regarding cancer, treatments, symptom management, and routine counseling. To ensure equity and address the waitlist-control nature of the design, these participants will be provided with the complete psychoeducational materials at the conclusion of the study's data collection period.
Anxiety Severity
Anxiety severity is measured using the Depression, Anxiety, and Stress Scale - Anxiety subscale (DASS-A). This subscale contains 14 questions utilizing a 4-point Likert scale ranging from 0 to 3. A higher score on this subscale indicates a higher severity of anxiety.
Depression Severity
Depression severity is measured using the Depression, Anxiety, and Stress Scale - Depression subscale (DASS-D). The subscale contains 14 questions rated on a 4-point Likert scale ranging from 0 to 3. Higher scores indicate a higher severity of depression.
Coping
Coping is measured using the Brief Coping Orientation to Problems Experienced Inventory (Brief COPE). It contains 28 items rated on a 4-point Likert scale that explore 14 coping strategies, which are divided into problem-focused coping and emotional-focused coping. A higher score represents greater coping strategies used by respondents.
Self-Efficacy
Self-efficacy is measured using the Cancer Behavior Inventory (CBI-B V1.0-12). It consists of 12 questions with a scale range of 1 to 9, where 1 is absolutely not sure and 9 is absolutely sure. A higher score indicates higher self-efficacy when dealing with cancer.
Quality of life - Functional Assessment of Cancer Therapy-G (FACT-G)
Quality of life is measured using the Functional Assessment of Cancer Therapy-G (FACT-G). The FACT-G consists of 27 items divided into 4 primary domains: physical wellbeing, social/family wellbeing, emotional wellbeing, and functional wellbeing. The total score is obtained by summing individual subscale scores, with a higher score indicating a higher quality of life.
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Gadjah Mada University
Lead sponsor
Universitas Riau
Sponsor institution
Universitas Riau
Collaborator
Bali Mandara Hospital, Denpasar, Bali, Indonesia
Collaborator
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