Effectiveness of a Digital Psychoeducational Intervention for Young Adults With Fertility Related Distress Following Cancer Diagnosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Anxiety Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Anxiety Severity
时间窗: 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.
Depression Severity
时间窗: 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.
Coping
时间窗: 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.
Self-Efficacy
时间窗: 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.
次要结局
- 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.)
研究者
Made Satya Nugraha Gautama
Research associate
Universitas Riau