CompletedNot Applicable

Short Questionnaire to Assess Individual Needs in Cancer Survivors in a Clinical Setting

Spain105 participantsStarted 2024-09-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility in modifying Life S-Can score

Timeframe: 3 months

Efficacy in improving overall quality of life

Timeframe: 3 months

Trial details

NCT IDNCT06582498

SponsorFundació d'investigació Sanitària de les Illes Balears

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-03-31

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