[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648858":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":38,"studyPopulation":26,"armGroups":39,"interventions":52,"overallOfficials":61,"centralContacts":69,"locations":78,"responsibleParty":95,"collaborators":98,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":26,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":26,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":26,"overallStatus":128,"whyStopped":26,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Gadjah Mada University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":26},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"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.",{"measure":14,"description":15,"timeFrame":12},"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.",{"measure":17,"description":18,"timeFrame":12},"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.",{"measure":20,"description":21,"timeFrame":12},"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.",[23],{"measure":24,"description":25,"timeFrame":12},"Quality of life - Functional Assessment of Cancer Therapy-G (FACT-G)","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\u002Ffamily 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.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","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.","SUPPORTIVE_CARE",{"masking":33,"maskingDescription":34,"whoMasked":35},"DOUBLE","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.",[36,37],"INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\n* Stage 1 (Literature Review): Identification of existing interventions to develop the digital psychoeducational framework.\n* 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.\n* Stage 3 (Intervention Trial): A pilot trial with 10 patients involving qualitative interviews to determine acceptability and comprehensiveness, followed by final program revisions.\n* Stage 4 (RCT): The primary randomized controlled trial assessing the effectiveness of the finalized digital psychoeducational intervention.\n\nSample 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.\n\nIntervention 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.\n\n* Modules: The application features four modules focusing on cancer and fertility, coping skills development, self-efficacy, and social support.\n* Format: Each module contains an e-booklet, a video, and quizzes, requiring approximately 35 to 50 minutes to complete in a single sitting.\n* Pacing: Modules will be released sequentially; each must be open for two days before the subsequent module unlocks to encourage content practice.\n* Engagement Features: The application includes automated motivational messaging, customizable daily reminders, and a direct messaging feature allowing patients to contact a counselor.\n* 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.\n\nControl 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.\n\nData Collection Timeline\n\nTo 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:\n\n1. Upon study enrollment.\n2. Following the fourth module for the experimental group, or two weeks post-enrollment for the control group.\n3. Three weeks post-module completion for the experimental group, or five weeks post-enrollment for the control group.\n4. Twelve weeks post-module completion for the experimental group, or fourteen weeks post-enrollment for the control group.\n\nDuring 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.\n\nStatistical Analysis Plan Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 21, with a significance level set at P\\\u003C0.05.\n\n* 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.\n* Advanced Modeling: Generalized Estimating Equations (GEE) will be utilized for longitudinal analysis across the four time points.\n* Missing Data Management: Strategies such as single and multiple imputation will be employed to manage anticipated missing data.\n* 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.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"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.",[45],"Behavioral: control group (standard of care + placebo).",{"label":47,"type":48,"description":49,"interventionNames":50},"Digital Psychoeducational Intervention Group","EXPERIMENTAL","The experimental group receives the digital psychoeducational intervention immediately",[51],"Behavioral: Digital psychoeducational intervention",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":26},"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.",[47],{"type":54,"name":59,"description":43,"armGroupLabels":60,"otherNames":26},"control group (standard of care + placebo).",[41],[62,66],{"name":63,"affiliation":64,"role":65},"Nurul Huda, RN, PhD","Universitas Riau","PRINCIPAL_INVESTIGATOR",{"name":67,"affiliation":68,"role":65},"Malissa Kay Shaw, PhD","University of Health Sciences and Pharmacy in St. Louis",[70,74],{"name":63,"role":71,"phone":72,"phoneExt":26,"email":73},"CONTACT","+62 82312213660","nurulmamaifda@gmail.com",{"name":75,"role":71,"phone":76,"phoneExt":26,"email":77},"Made Satya Nugraha Gautama, RN, MSc","+6282247469181","satyanugraha.g@gmail.com",[79],{"facility":80,"status":26,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Bali Mandara Genderal Hospital","Denpasar","Bali","81113","Indonesia","ID",{"type":87,"coordinates":88},"Point",[89,90],115.21667,-8.65,{"lat":90,"lon":89},[93],{"name":94,"role":71,"phone":76,"phoneExt":26,"email":77},"Made Satya Nugraha Gautama, RN, M.Sc",{"type":65,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":64,"oldNameTitle":26,"oldOrganization":26},"Made Satya Nugraha Gautama","Research associate",[99,100],{"name":64,"class":6},{"name":101,"class":102},"Bali Mandara Hospital, Denpasar, Bali, Indonesia","UNKNOWN","100648858","digital-psychoeducational-intervention-for-young-adults-with-fertility-related-distress-following-cancer-diagnosis-100648858",false,"NCT07729696","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","Inclusion Criteria:\n\n* Diagnosed with cancer.\n* Self-report fertility-related distress.\n* Aged 18 to 40 years old.\n* Able to speak Bahasa (the national language of Indonesia).\n* Have a performance status ECOG score of 0-2.\n\nExclusion Criteria:\n\n* Have a severe medical condition which impacts their level of consciousness.\n* Diagnosed with a major psychiatric comorbidity.\n* Unable to fill out the study questionnaires.\n* Unable to decide to participate due to cognitive impairment, decreasing consciousness level, or difficulty verbalizing their wishes.","ALL","18 Years","40 Years",{"count":114,"type":115},38,"ESTIMATED","INTERVENTIONAL",[118],"NA","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.",[121,122,123,124,125,126,127],"Neoplasm","Cancer","Psychoeducational Intervention","Young Adults","Fertility Outcomes","Psychological Distress","Anxiety","NOT_YET_RECRUITING","2026-07-23",{"date":131,"type":132},"2026-07-27","ACTUAL",{"date":134,"type":115},"2026-08-24",{"date":136,"type":115},"2026-12-14",{"name":5,"class":6},1]