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

NCT07729696 | Not Yet Recruiting

• 1 other identifier: 2118
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Anxiety Severity

  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

  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

  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

  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 Outcomes (1)

• Quality of life - Functional Assessment of Cancer Therapy-G (FACT-G)

  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.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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).

Digital Psychoeducational Intervention Group

EXPERIMENTAL

The experimental group receives the digital psychoeducational intervention immediately

Behavioral: Digital psychoeducational intervention

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.

Digital Psychoeducational Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead
• Universitas Riau: collaborator
• Bali Mandara Hospital, Denpasar, Bali, Indonesia: collaborator

Study Sites (1)

Bali Mandara Genderal Hospital

Denpasar, Bali, 81113, Indonesia

Location

Related Publications (3)

• Huda 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 BACKGROUND

• Benedict 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 BACKGROUND

• Allison 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 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Interventions

Control Groups; Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nurul Huda, RN, PhD

  Universitas Riau

  PRINCIPAL INVESTIGATOR

• Malissa Kay Shaw, PhD

  University of Health Sciences and Pharmacy in St. Louis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurul Huda, RN, PhD

CONTACT

+62 82312213660; nurulmamaifda@gmail.com

Made Satya Nugraha Gautama, RN, MSc

CONTACT

+6282247469181; satyanugraha.g@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study utilizes masking to minimize bias during the data collection phase. Both the principal researcher and the trained research assistant responsible for collecting patient data are blinded to the participants' group allocations. Additionally, the head nurse assisting with participant recruitment has no foreknowledge of group assignments, ensuring the consent process is not influenced.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research associate

Model Details: This study employs a randomized controlled trial (RCT) design based on CONSORT guidelines to evaluate a digital psychoeducational intervention. Participants are assigned to an experimental or control group in a 1:1 ratio using a randomized "lucky draw" method, where patients choose an unlabeled envelope. The trial utilizes a parallel-group, waitlist-control model. The experimental group immediately receives the digital intervention, while the control group receives standard care throughout the data collection period. To ensure equity, the control group receives the psychoeducational materials after data collection concludes. To minimize bias, the principal researcher and research assistant are strictly blinded to group allocations during data collection. Furthermore, the head nurse assisting with recruitment remains blinded to assignments to prevent influencing patient consent.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 27, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)