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临床试验/NCT06582498
NCT06582498已完成不适用

Life S-Can: a Novel Clinical Tool to Effectively Assess Individual Needs in Cancer Survivorship Care and Improve Quality of Life in Cancer Survivors

Fundació d'investigació Sanitària de les Illes Balears2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年9月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
105
试验地点
2
主要终点
Feasibility in modifying Life S-Can score

研究概览

简要总结

The rate of cancer survivorship is increasing, posing the need to create high quality survivorship care plans. Traditionally, follow-up of cancer survivors has focused on detection of cancer recurrence or new cancers, but often it does not fully address behavioural and psychosocial elements which could improve quality of life (QoL) and potentially decrease recurrence risk. There is a current lack of short, validated screeners to assess diet, lifestyle and other behaviours that might influence QoL and prognosis in cancer survivors. The hypothesis of this project is that the creation of a screener with the capacity to rapidly, validly and effectively assess nutritional factors, lifestyle, sleep quality and psychosocial distress in cancer survivors could be useful to identify individuals who may need further care and support. The aim is to create a valid and rapid tool (Life S-Can) to evaluate a total of seven domains (body composition, physical activity, diet, alcohol intake, smoking, sleeping behaviour and psychosocial distress) in cancer survivors for its use in a clinical setting to improve survivorship care and QoL. The project is divided into three phases and will be carried out in one year at the University Hospital Son Espases (HUSE) (Palma, Spain). The objective of Phase I is to design the screener, which will be administered to a small convenience sample to determine comprehension, clarity and usefulness. In Phase II, Life S-Can will be validated in cancer survivors (n=100) at HUSE and a pilot intervention will be carried out with the objective to test the feasibility of a larger intervention to effectively implement Life S-Can in clinical settings to improve QoL in cancer survivors. For this, patients will be recruited by the Oncology Department and will be invited to attend the Clinical Trials Unit for an exhaustive assessment. A research dietitian will administer Life S-Can and will then collect data using validated questionnaires and objective measurements to compare to the data obtained with the Life S-Can screener. Participants will then be randomly allocated to either the Low Intensity Intervention Group (LIIG) or Active Intervention Group (AIG). LIIG patients will receive standard care and advice given to cancer survivors, and AIG patients will receive personalised feedback (by means of individual and group sessions) in order to improve their body composition, physical activity, diet, alcohol intake, and psychosocial elements based on their answers, by trained professionals. Patients of both groups will also answer both Life S-Can and validated questionnaires at baseline and after three months. Outcome measurements will be indicators of feasibility (completion of questionnaires), acceptability (by patients, health professionals), behavioural changes (diet, physical activity, psychosocial distress) and QoL. Finally, Phase III consists of a qualitative study conducted in cancer patients and health professionals to obtain data to design an implementation study. Cancer survivors care should be multifactorial; however, often, due to time constraints and clinical burden, health professionals might not assess certain aspects relevant for cancer survivors' QoL, such as nutritional status, diet, physical and mental health adequately. Life S-Can will enable clinicians, health practitioners, charities and other stakeholders work with cancer survivors early-on and refer them to adequate health and mental care teams and resources.

详细描述

The aim of this project is to develop a valid and rapid screening tool (Life S-Can) with the capacity to evaluate a total of seven domains (body composition, physical activity, diet, alcohol intake, smoking, sleeping behaviour and psychosocial distress) in cancer survivors for its use in a clinical setting to improve survivorship care and QoL. The project is divided into four specific aims (SA) and will be carried out in one year at the University Hospital Son Espases (HUSE) (Palma, Spain).

SA1: Develop a short screener (Life S-Can) to evaluate body composition, physical activity, diet, alcohol intake, smoking habits, sleeping behaviour and psychosocial distress in cancer survivors.

SA2. Determine relative and construct validity of individual domains and total score of the Life S-Can in cancer survivors using data obtained from validated and objective measurements.

SA3. Carry out a pilot intervention study in cancer survivors to determine the feasibility, acceptability and efficacy of Life S-Can.

SA4. Carry out a qualitative study in cancer survivors and health professionals to design an implementation study.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ≥ 18 years old; men & women; able to read and understand Spanish; prior diagnosis of cancer (stages I to III); have completed all systemic treatment (surgery, chemotherapy, radiation therapy) at least ≥3 months prior to the study start date; be currently considered cancer free; able to attend visits at HUSE.

排除标准

  • Ongoing cancer or cancer treatment; have a debilitating medical or psychiatric illness; presenting a disorder that compromises comprehension (e.g., dementia); pregnancy/breastfeeding.

研究组 & 干预措施

Active intervention

Experimental

Consists of participants (50% of the total recruited) which will receive the Active Intervention.

干预措施: Active intervention (Behavioral)

Low-intensity intervention

Active Comparator

Consists of participants (50% of the total recruited) which will receive the Low Intensity Intervention.

干预措施: Low-intensity intervention (Behavioral)

结局指标

主要结局

Feasibility in modifying Life S-Can score

时间窗: 3 months

The outcome will be measured through the administration of Life S-Can and a quality of life questionnaire

Efficacy in improving overall quality of life

时间窗: 3 months

The outcome will be measured through the administration of Life S-Can and a quality of life questionnaire

次要结局

  • Changes in body composition(3 months)
  • Changes in physical activity levels(3 months)
  • Change in diet(3 months)

研究者

发起方
Fundació d'investigació Sanitària de les Illes Balears
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alice Mary Lillian Chaplin

Principal Investigator

Fundació d'investigació Sanitària de les Illes Balears

研究点 (2)

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