Short Questionnaire to Assess Individual Needs in Cancer Survivors in a Clinical Setting
NCT Number: NCT06582498
Acronym: LIFE S-CAN
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer Survivors
Interventions: BEHAVIORAL: Active intervention|BEHAVIORAL: Low-intensity intervention
Sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-04
Locations: Fundació Instituto de Investigación Sanitaria de las Islas Baleares (IDISBA), Palma De Mallorca, Illes Balears, 07120, Spain

Summary:
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.

Primary Outcome Measures: Feasibility in modifying Life S-Can score, The outcome will be measured through the administration of Life S-Can and a quality of life questionnaire, 3 months|Efficacy in improving overall quality of life, The outcome will be measured through the administration of Life S-Can and a quality of life questionnaire, 3 months
Secondary Outcome Measures: Changes in body composition, Changes in body composition will be measured at the end of the study by bioimpedence analysis (to detect changes in body composition). Outcome meassure will consist of weights, muscle mass, fat mass, etc., 3 months|Changes in physical activity levels, Changes in physical activity levels will be measured at the end of the study by administration of validated questionnaires to determine physical activity in participants. The outcome measure will be time spent doing physical activity at different levels of intensities., 3 months|Change in diet, Changes in diet will be measured at the end of the study by administration of validated questionnaires to determine habitual diet in participants., 3 months
Other Outcome Measures: Screener validation, Validation of the screener (Life S-Can) will be carried out by means of administration of validated questionnaires (on physical activity, diet, alcohol intake, smoking habits, sleeping and mental health), together with objective measurements (body weight and body composition, accelerometres for physical activity, and cortisol levels in saliva)., 3 months|Reproducibility of the Life S-can screener, Reproducibility of the screener (Life S-Can) will be measured using the retest method., 10 days|Qualitative study, The qualitative study will determine feasibility of implementation in a clinical setting. We will evaluate and take into consideration barriers and facilitators expressed by participants to improve the implementation of the screener., The qualitative study will be carried out after the pilot intervention study and the validation of the screener have concluded. It is expected to take approximately 2 months to carry out.