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

Sponsor
Gadjah Mada University
Study ID
NCT07729696
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Digital psychoeducational intervention — BEHAVIORAL
    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.
  • control group (standard of care + placebo). — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Aug 24, 2026
Status verified
Jul 2026
Primary completion
Dec 7, 2026
Completion
Dec 14, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Control Group
    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.
  • Experimental: Digital Psychoeducational Intervention Group
    The experimental group receives the digital psychoeducational intervention immediately

Primary Outcome Measure

Anxiety Severity [ Time Frame: Upon enrollment; after the fourth module or 2 weeks post-enrollment; 3 weeks post-module or 5 weeks post-enrollment; and 12 weeks post-module or 14 weeks post-enrollment. ]

Central Contacts

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