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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorGadjah Mada University

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosed with cancer.

Self-report fertility-related distress.

Aged 18 to 40 years old.

Able to speak Bahasa (the national language of Indonesia).

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

38 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Gadjah Mada University

Lead sponsor

Universitas Riau

Sponsor institution

Universitas Riau

Collaborator

Bali Mandara Hospital, Denpasar, Bali, Indonesia

Collaborator