Clinical trial · Interventional
Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis
Effectiveness of a Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Fertility Outcomes | — | UNRESOLVED | — |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Psychoeducational Intervention | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
| Young Adults | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| control group (standard of care + placebo). | Behavioral | — | UNRESOLVED |
| Digital psychoeducational intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- 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.
- interventionNames
- Behavioral: control group (standard of care + placebo).
- type
- EXPERIMENTAL
- label
- Digital Psychoeducational Intervention Group
- description
- The experimental group receives the digital psychoeducational intervention immediately
- interventionNames
- Behavioral: Digital psychoeducational intervention
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDHuda N, Lin YK, Shaw MK, Hsu YY, Chang HJ. Psychometric properties and cross-cultural adaptation of the Indonesian version of the Brief COPE in a sample of advanced cancer patients. PLoS One. 2022 Nov 28;17(11):e0275083. doi: 10.1371/journal.pone.0275083. eCollection 2022. PMID 36441773
- BACKGROUNDBenedict C, Shuk E, Ford JS. Fertility Issues in Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2016 Mar;5(1):48-57. doi: 10.1089/jayao.2015.0024. Epub 2015 Nov 18. PMID 26812452
- BACKGROUNDAllison KR, Patterson P, Ussher JM, McDonald FEJ, Perz J. Evaluating Maybe Later Baby, a Fertility Information Resource for Adolescents and Young Adults Diagnosed with Cancer: A Randomized, Controlled Pilot Study. J Adolesc Young Adult Oncol. 2023 Feb;12(1):101-109. doi: 10.1089/jayao.2021.0206. Epub 2022 Mar 24. PMID 35333618