Chaplin Alice, Wordsworth Janna, Prohens Lara, Obrador-Hevia Antònia, Guillot Monica, Ricci-Cabello Ignacio, Sesé Albert, Romaguera Dora
Health Research Institute of the Balearic Islands (IdISBa), Palma, Spain.
Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.
PLoS One. 2025 Jun 5;20(6):e0323671. doi: 10.1371/journal.pone.0323671. eCollection 2025.
Current clinical care may not address behavioural and psychosocial elements which can influence quality of life (QoL) and recurrence risk of people living with and beyond cancer (PLWBC). There is a lack of validated tools to assess diet, lifestyle and mental health in PLWBC. We have developed a screener to identify individuals who may need further support beyond cancer recurrence. The aim is two-fold: 1) validate the screener in PLWBC; and 2) carry out a pilot feasibility study (PFS) to explore the impact of a lifestyle complex intervention (diet, physical activity and mental health components) on the QoL of PLWBC.
The study will be carried out at the University Hospital Son Espases (Spain) in PLWBC. A face validity study (n = 15) will assess construct interpretation, completion time, and acquiescence of the screener. For construct validity and reproducibility analysis (n = 100), participants will answer the screener together with validated diet, lifestyle, and mental health questionnaires for comparison. Body composition, physical activity, strength and cortisol levels will be assessed using validated instruments. All participants will answer the screener 7-10 days later for reproducibility analysis. Participants will then be randomized (1:1) to the Low Intervention (LI) or the High Intervention (HI) for the PFS study. LI will receive general advice regarding diet, lifestyle and mental health, and HI will receive individual and group sessions with specialised health professionals. Participants will be followed for three months. Primary outcomes include: 1) validity and reproducibility of the screener; and 2) feasibility of a complex intervention to improve QoL of PLWBC. Secondary outcomes include changes in screener answers and body composition.
A validated screener which detects PLWBC's needs could be used in follow-up care plans. The PFS will inform on the recruitment of participants and identify potential shortfalls of the design and efficacy.
ClinicalTrials.gov NCT06582498.
当前的临床护理可能未涉及行为和心理社会因素，而这些因素会影响癌症患者及癌症康复者（PLWBC）的生活质量（QoL）和复发风险。目前缺乏用于评估PLWBC饮食、生活方式和心理健康的有效工具。我们开发了一种筛查工具，以识别那些可能需要癌症复发之外进一步支持的个体。目的有两个：1）在PLWBC中验证该筛查工具；2）开展一项试点可行性研究（PFS），以探索一种生活方式综合干预措施（饮食、体育活动和心理健康部分）对PLWBC生活质量的影响。
该研究将在西班牙Son Espases大学医院对PLWBC进行。一项表面效度研究（n = 15）将评估筛查工具的结构解释、完成时间和默认情况。对于结构效度和可重复性分析（n = 100），参与者将回答该筛查工具，并同时回答经过验证的饮食、生活方式和心理健康问卷以作比较。将使用经过验证的仪器评估身体成分、体育活动、力量和皮质醇水平。所有参与者将在7 - 10天后再次回答筛查工具以进行可重复性分析。然后，参与者将被随机分配（1:1）到低干预组（LI）或高干预组（HI）进行PFS研究。LI组将接受有关饮食、生活方式和心理健康的一般建议，HI组将接受专业健康专家的个体和小组辅导。参与者将被随访三个月。主要结果包括：1）筛查工具的效度和可重复性；2）改善PLWBC生活质量的综合干预措施的可行性。次要结果包括筛查工具答案和身体成分的变化。
一种能检测PLWBC需求的经过验证的筛查工具可用于后续护理计划。PFS将为参与者招募提供信息，并识别设计和疗效方面的潜在不足。
ClinicalTrials.gov NCT06582498。
