Short Questionnaire to Assess Individual Needs in Cancer Survivors in a Clinical Setting (LIFE S-CAN)

March 30, 2026 updated by: Alice Mary Lillian Chaplin, Fundació d'investigació Sanitària de les Illes Balears

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The project herein presented proposes three phases: tool development (Phase I); validation of the tool (Phase II - validation and pilot intervention study); and qualitative (Phase III).

PHASE I: Phase I refers to SA1.

Recruit an expert panel: Together with the Principal Investigator, five key personnel have been listed in this project, all of whom carry out research at the Health Research Institute of the Balearic Islands (IdISBa, Spain) together with other duties (university professor, medical doctor). Key personnel not contemplated as researchers in this project include international experts in nutrition and cancer and will be consulted throughout the project. Cancer survivors will also be contacted at this stage (through the hospital) to involve them in the design stage.

Elements of the intervention at discussion: A series of meetings, semi-structured interviews and panel groups will be planned with expert panel members and non-scientific actors to define the best intervention. Elements to be defined during this stage are: scoring of the individual domains of Life S-Can herein studied and traffic-light system (good, intermediate and non-adherence, which will direct the intervention and health professionals to be visited), monitoring of patients, pipeline, feedback, appointment system, Clinical Trials Unit and data collection.

PHASE II:

Phase II consists of two objectives: a validation study (SA2) and a pilot intervention study (SA3). The validation study will consist of three visits to the research/hospital facility. The first visit will be at the Clinical Trials Unit, will take approximately 1 h and will be divided into three parts: 1) Administration of Life S-Can; 2) Administration of validated questionnaires; and 3) Obtain objective measurements of the patient. The second visit will also be at the Clinical Trials Unit and will take approximately 10-15 minutes. Participants will be asked to return the accelerometer and complete the Life S-Can questionnaire again (reproducibility). At this visit, patients will be randomly allocated to the Low Intensity Intervention Group (LIIG) or Active Intervention Group (AIG). The third and final visit will also be at the Clinical Trials Unit and will take approximately 30 minutes. The participant will be asked to answer the Life S-Can again, together with other questionnaires (QLQ-C30) and anthropometric measurements, to measure changes in QoL.

The pilot intervention study (SA3) will be designed using a multi-disciplinary approach, whereby knowledge and expertise in oncology, nutrition, epidemiology, psychology and psychometry, validation and implementation will be called upon. In addition, the views and experiences of cancer patients and patient organizations are essential in designing an effective intervention; hence non-scientific authors will be contacted and included in this phase.

This intervention phase is divided into three stages: intervention design, patient recruitment and group allocation and intervention. Participation in this study will entail visits to the Clinical Trials Unit at IdISBa, located within the Hospital Universitari Son Espases. When possible, visits will be coordinated with other routine appointments at the hospital in order to reduce as much as possible the burden on the participant. Dietary, physical activity and psychologic interventions will be carried out by in-house researchers (trained oncological dietitian) and external health professionals.

Participants allocated to the LIIG will receive routine advice offered by their oncological care team and a set of standard recommendations offered by the World Cancer Research Fund, the American Institute for Cancer Research and the American Cancer Society. Participants in the AIG will also receive this, and will also be offered the chance to visit an oncological dietitian, a physical activity health professional and a psychologist (one individual session, and one group session).

At the final visit, Life S-Can and QLQ-C30 questionnaires will be administered again in order to determine any changes or impact on lifestyle and quality of life. Information regarding feasibility and acceptability of the intervention will be collected from participants.

PHASE III. The aim of the qualitative study is to design an implementation study.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07120
        • Fundació Instituto de Investigación Sanitaria de las Islas Baleares (IDISBA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active intervention
Consists of participants (50% of the total recruited) which will receive the Active Intervention.
Behavioral: Active intervention
This group will receive a pamphlet with diet and lifestyle recommendations for cancer survivors at randomization (2nd visit). Furthermore, they will be offered 3 individual sessions with health professionals (oncological dietitian, sports therapist, and oncological psychologist) and 3 group sessions with the same professionals. The duration of the individual visits is expected to be 45-60 minutes approximately, and group sessions will be planned for 1.5h duration approximately.
Active Comparator: Low-intensity intervention
Consists of participants (50% of the total recruited) which will receive the Low Intensity Intervention.
Behavioral: Low-intensity intervention
This group will receive a pamphlet with diet and lifestyle recommendations for cancer survivor at randomization (2nd visit). These recommendations are all based on information from the World Cancer Research Fund, the American Institute for Cancer Research, and the American Cancer Society.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility in modifying Life S-Can score
Time Frame: 3 months
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
Time Frame: 3 months
The outcome will be measured through the administration of Life S-Can and a quality of life questionnaire
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body composition
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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

Outcome Measure
Measure Description
Time Frame
Screener validation
Time Frame: 3 months
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
Time Frame: 10 days
Reproducibility of the screener (Life S-Can) will be measured using the retest method.
10 days
Qualitative study
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació d'investigació Sanitària de les Illes Balears

Investigators

  • Principal Investigator: Alice Chaplin, PhD, CIBER (Consorcio Investigación Biomédica en Red); IdISBa (Fundació Instituto de Investigación Sanitaria de las Islas Baleares)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

August 29, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMP23/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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