Clinical trial NCT06582498: Short Questionnaire to Assess Individual Needs in Cancer Survivors in a Clinical Setting
Official title: Life S-Can: a Novel Clinical Tool to Effectively Assess Individual Needs in Cancer Survivorship Care and Improve Quality of Life in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer Survivors
Keywords: Cancer survivorship
Screener
Diet
Physical activity
Psychosocial distress
Lead sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sponsor class: OTHER_GOV
First posted: 2024-09-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A random allocation system will be applied to participants, which will be allocated to the Low Intensity Intervention Group (LIIG) or the Active Intervention Group (AIG). Both groups will attend a first, baseline visit offered to all participants with a trained dietitian, who will administer the Life S-Can questionnaire and a series of validated questionnaires. The LIIG will receive the standard care and recommendations already provided by the Oncology Department of the hospital and a set of recommendations for cancer prevention offered by the WCRF, the AICR and the ACS. The AIG will receive the same recommendations as the LIIG and will be offered to see an oncological dietitian (diet domain), a physical activity health professional (physical activity) and/or a psychologist (psychosocial distress) for two visits (one individual, one group session). All participants will attend a final visit after 3 months to collect data on feasibility, acceptability and efficacy of the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility in modifying Life S-Can score
timeFrame: 3 months
measure: Efficacy in improving overall quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Changes in body composition
timeFrame: 3 months
measure: Changes in physical activity levels
timeFrame: 3 months
measure: Change in diet
timeFrame: 3 months
Other outcomes:
measure: Screener validation
timeFrame: 3 months
measure: Reproducibility of the Life S-can screener
timeFrame: 10 days
measure: Qualitative study
timeFrame: 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.
Locations:
city: Palma De Mallorca
country: Spain
facility: Fundació Instituto de Investigación Sanitaria de las Islas Baleares (IDISBA)
state: Illes Balears
Study officials:
affiliation: CIBER (Consorcio Investigación Biomédica en Red); IdISBa (Fundació Instituto de Investigación Sanitaria de las Islas Baleares)
name: Alice Chaplin, PhD
role: PRINCIPAL_INVESTIGATOR
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