Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis

Study Design and Framework This research will employ a four-stage design, culminating in a randomized controlled trial (RCT) based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The intervention's theoretical framework integrates Lazarus and Folkman's Coping Theory with Bandura's self-efficacy theory to address how young adult cancer patients cognitively and behaviorally manage illness-related challenges and fertility-related distress.

• Stage 1 (Literature Review): Identification of existing interventions to develop the digital psychoeducational framework.
• Stage 2 (Content Validity Testing): Assessment and revision of the intervention content by a seven-member expert panel comprising nursing experts, medical oncology specialists, head nurses, fertility specialists, and a clinical psychologist.
• Stage 3 (Intervention Trial): A pilot trial with 10 patients involving qualitative interviews to determine acceptability and comprehensiveness, followed by final program revisions.
• Stage 4 (RCT): The primary randomized controlled trial assessing the effectiveness of the finalized digital psychoeducational intervention.

Sample Size and Randomization The study will be conducted at the Oncology Inward Unit of Arifin Ahmad Hospital in Pekanbaru, Indonesia. The required sample size was calculated using G*Power based on an effect size of 0.81, alpha=5% (two-tailed), 90% power, and a 1:1 allocation ratio. Accounting for an anticipated 10% dropout rate, the targeted sample size is 38 patients per group. Eligible participants will be randomized into the experimental or control group using a lucky draw method, wherein patients independently select an unlabeled envelope to dictate their assignment.

Intervention Delivery and Monitoring Participants randomized to the experimental group will receive a digital psychoeducational intervention comprising an initial structured, in-person introduction followed by thematic modules delivered via a mobile application.

• Modules: The application features four modules focusing on cancer and fertility, coping skills development, self-efficacy, and social support.
• Format: Each module contains an e-booklet, a video, and quizzes, requiring approximately 35 to 50 minutes to complete in a single sitting.
• Pacing: Modules will be released sequentially; each must be open for two days before the subsequent module unlocks to encourage content practice.
• Engagement Features: The application includes automated motivational messaging, customizable daily reminders, and a direct messaging feature allowing patients to contact a counselor.
• Monitoring: The research team will track participant progress via application activity. Study staff will also conduct a follow-up phone call two weeks after the introductory session to troubleshoot technical difficulties, encourage engagement, and solicit verbal feedback.

Control Group Procedures Participants 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.

Data Collection Timeline

To mitigate bias, data will be collected by a blinded principal researcher and a trained research assistant. Researchers will administer surveys to both cohorts at four distinct time points:

• Upon study enrollment.
• Following the fourth module for the experimental group, or two weeks post-enrollment for the control group.
• Three weeks post-module completion for the experimental group, or five weeks post-enrollment for the control group.
• Twelve weeks post-module completion for the experimental group, or fourteen weeks post-enrollment for the control group.

During the second, third, and fourth collection periods, administrators will also query participants regarding any unrelated stressful or traumatic events to account for external factors impacting their wellbeing.

Statistical Analysis Plan Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 21, with a significance level set at P<0.05.

• Descriptive and Bivariate Analysis: Normal distribution will be verified via Kolmogorov-Smirnov and Shapiro-Wilk tests. Group differences will be evaluated using Independent T-tests or Mann-Whitney tests, depending on data distribution. Baseline categorical variables will be analyzed using Chi-square or Fisher's exact tests.
• Advanced Modeling: Generalized Estimating Equations (GEE) will be utilized for longitudinal analysis across the four time points.
• Missing Data Management: Strategies such as single and multiple imputation will be employed to manage anticipated missing data.
• Subgroup Analysis: A sub-analysis will stratify experimental participants by adherence levels, categorized as high or low activity. High activity is strictly defined as opening at least half the modules, accumulating a minimum of 20 minutes of total app usage, and completing 50% of the integrated quizzes.

Inclusion criteria

• 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 performance status ECOG score of 0-2.

Exclusion criteria

• 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.