Effect of journaling on person-centric outcomes in adolescents and young adults receiving specialist palliative care: 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
- 82
- 试验地点
- 1
- 主要终点
- Compare the change in patient’s quality of life from baseline to
研究概览
简要总结
Adolescents and Young Adults (AYAs) with advanced cancer face profound physical, psychological, and existential distress during a critical developmental stage, compounded by unmet psychosocial needs. In resource-limited settings like India, where specialist palliative care is scarce and culturally tailored interventions for AYAs are lacking, scalable, low-cost solutions are urgently needed. Guided journaling is a promising yet understudied approach to address this gap. This randomized controlled trial evaluates the effect of guided journaling on person-centric outcomes among adolescents and young adults (AYAs; aged 15–39 years) with advanced cancer receiving specialist palliative care at Christian Medical College, Vellore, India. Participants (n=82) are randomized 1:1 to either a guided journaling intervention (at-least three times a week, for a month using structured prompts focused on emotional processing, gratitude, and coping) alongside usual palliative care or to usual palliative care alone. The outcomes assessed will be changes in quality of life and psychological distress, measured using validated tools at baseline and post intervention. In addition, qualitative interviews will be conducted with a subset of participants to explore their perceptions of journaling, including its emotional impact, acceptability, and perceived benefits or challenges. This mixed-methods approach aims to provide a holistic understanding of how journaling may support psychological wellbeing in AYAs facing serious illness. This study aims to address an important gap in the availability of low-cost, scalable, and culturally appropriate psychosocial interventions for AYAs in low-resource settings. Findings from this trial have the potential to inform future palliative care practices and guidelines in low- and middle-income countries (LMICs), where specialist psychological support is often limited. By centering the voices and experiences of young people in palliative care, the study contributes to a growing emphasis on person-centered, age appropriate, and holistic care models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of advanced cancer, i.e., any solid or hematological malignancy unlikely to be cured or controlled with treatment.
- •AYAs who are physically able and have the cognition to be able to think, reflect and write.
- •Able to read and write in a language they are familiar with.
排除标准
- •Cognitive impairment, confusion, or delirium prohibiting reliable self-report.
- •Sensorimotor deficits preventing participation.
- •Severe comorbid psychiatric illness.
结局指标
主要结局
Compare the change in patient’s quality of life from baseline to
时间窗: At Baseline (T0) & At 1 week (T1)
day 7 between intervention arm and control arm as measured on the Functional Assessment of Chronic Therapy - Spiritual Well-being (FACIT-Sp)
时间窗: At Baseline (T0) & At 1 week (T1)
次要结局
- Compare the change in patient’s quality of life from baseline to one month between intervention arm and control arm as measured on(the Functional Assessment of Chronic Therapy - Spiritual Well-being (FACIT-Sp).)
- Compare the change in patients’ psychological distress from baseline to day 7 between intervention arm and control arm as measured on Hospital Anxiety and Depression Scale-Anxiety and Depression {HADS (A & D)} scores.(T0-Day 0, T1-Day 7)
- Compare the change in patients’ psychological distress from baseline(to one month between intervention arm and control arm as measured on Hospital Anxiety and Depression Scale-Anxiety and Depression {HADS (A & D)} scores.)
研究者
Aby John Thampi
Christian Medical College Vellore