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

July 23, 2026 updated by: Made Satya Nugraha Gautama, Gadjah Mada University

Effectiveness of a Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis: A Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Upon study enrollment.
  2. Following the fourth module for the experimental group, or two weeks post-enrollment for the control group.
  3. Three weeks post-module completion for the experimental group, or five weeks post-enrollment for the control group.
  4. 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.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia, 81113
        • Bali Mandara Genderal Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Experimental: Digital Psychoeducational Intervention Group
The experimental group receives the digital psychoeducational intervention immediately
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Anxiety severity is measured using the Depression, Anxiety, and Stress Scale - Anxiety subscale (DASS-A). This subscale contains 14 questions utilizing a 4-point Likert scale ranging from 0 to 3. A higher score on this subscale indicates a higher severity of anxiety.
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.
Depression 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.
Depression severity is measured using the Depression, Anxiety, and Stress Scale - Depression subscale (DASS-D). The subscale contains 14 questions rated on a 4-point Likert scale ranging from 0 to 3. Higher scores indicate a higher severity of depression.
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.
Coping
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.
Coping is measured using the Brief Coping Orientation to Problems Experienced Inventory (Brief COPE). It contains 28 items rated on a 4-point Likert scale that explore 14 coping strategies, which are divided into problem-focused coping and emotional-focused coping. A higher score represents greater coping strategies used by respondents.
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.
Self-Efficacy
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.
Self-efficacy is measured using the Cancer Behavior Inventory (CBI-B V1.0-12). It consists of 12 questions with a scale range of 1 to 9, where 1 is absolutely not sure and 9 is absolutely sure. A higher score indicates higher self-efficacy when dealing with cancer.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life - Functional Assessment of Cancer Therapy-G (FACT-G)
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.
Quality of life is measured using the Functional Assessment of Cancer Therapy-G (FACT-G). The FACT-G consists of 27 items divided into 4 primary domains: physical wellbeing, social/family wellbeing, emotional wellbeing, and functional wellbeing. The total score is obtained by summing individual subscale scores, with a higher score indicating a higher quality of life.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Collaborators

Universitas Riau
Bali Mandara Hospital, Denpasar, Bali, Indonesia

Investigators

  • Principal Investigator: Nurul Huda, RN, PhD, Universitas Riau
  • Principal Investigator: Malissa Kay Shaw, PhD, University of Health Sciences and Pharmacy in St. Louis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 24, 2026

Primary Completion (Estimated)

December 7, 2026

Study Completion (Estimated)

December 14, 2026

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe