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

Summary

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.

Conditions

• Neoplasm
• Cancer
• Psychoeducational Intervention
• Young Adults
• Fertility Outcomes
• Psychological Distress
• Anxiety

Interventions

BEHAVIORAL

Digital psychoeducational intervention

The 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.

BEHAVIORAL

control group (standard of care + placebo).

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.

Sponsors & Collaborators

• Universitas Riau

  collaborator OTHER

• Bali Mandara Hospital, Denpasar, Bali, Indonesia

  collaborator UNKNOWN

• Gadjah Mada University

  lead OTHER

Principal Investigators

• Nurul Huda, RN, PhD · Universitas Riau

• Malissa Kay Shaw, PhD · University of Health Sciences and Pharmacy in St. Louis

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-24

Primary Completion

2026-12-07

Completion

2026-12-14

Countries

• Indonesia

Study Locations