Cancer SurvivorsLIFE S-CANNCT06582498
Short Questionnaire to Assess Individual Needs in Cancer Survivors in a Clinical Setting
A study testing Active intervention and Low-intensity intervention in people with Cancer Survivors, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Active intervention and Low-intensity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Ongoing cancer or cancer treatment; have a debilitating medical or psychiatric illness; presenting a disorder that compromises comprehension (e.g., dementia); pregnancy/breastfeeding.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Instituto de Investigación Sanitaria de las Islas Baleares (IDISBA)
Palma de Mallorca, Balearic Islands, 07120
About this study
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
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.
Read the 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.
- Conditions
- Cancer Survivors
- Being tested
- Active intervention, Low-intensity intervention
- Keywords
- Cancer survivorship, Screener, Diet, Physical activity, Psychosocial distress
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active interventionBehavioural
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.
Low-intensity interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | Consists of participants (50% of the total recruited) which will receive the Active Intervention. Receives: Behavioral: Active intervention |
| Low-intensity intervention | Active comparator | Consists of participants (50% of the total recruited) which will receive the Low Intensity Intervention. Receives: Behavioral: Low-intensity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start2 Sep 2024
- Primary completion31 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alice Mary Lillian Chaplin, Fundació d'investigació Sanitària de les Illes Balears
- Investigators
- Alice Chaplin, PhD, Principal investigator, CIBER (Consorcio Investigación Biomédica en Red); IdISBa (Fundació Instituto de Investigación Sanitaria de las Islas Baleares)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582498
- Sponsor's protocol ID
- IMP23/01
- Acronym
- LIFE S-CAN
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller KD, Nogueira L, Devasia T, Mariotto AB, Yabroff KR, Jemal A, Kramer J, Siegel RL. Cancer treatment and survivorship statistics, 2022. CA Cancer J Clin. 2022 Sep;72(5):409-436. doi: 10.3322/caac.21731. Epub 2022 Jun 23.
PubMed 35736631Parry C, Kent EE, Mariotto AB, Alfano CM, Rowland JH. Cancer survivors: a booming population. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):1996-2005. doi: 10.1158/1055-9965.EPI-11-0729.
PubMed 21980007Jefford M, Howell D, Li Q, Lisy K, Maher J, Alfano CM, Rynderman M, Emery J. Improved models of care for cancer survivors. Lancet. 2022 Apr 16;399(10334):1551-1560. doi: 10.1016/S0140-6736(22)00306-3.
PubMed 35430022de Rooij BH, Park ER, Perez GK, Rabin J, Quain KM, Dizon DS, Post KE, Chinn GM, McDonough AL, Jimenez RB, van de Poll-Franse LV, Peppercorn J. Cluster Analysis Demonstrates the Need to Individualize Care for Cancer Survivors. Oncologist. 2018 Dec;23(12):1474-1481. doi: 10.1634/theoncologist.2017-0558. Epub 2018 May 8.
PubMed 29739897Dai S, Mo Y, Wang Y, Xiang B, Liao Q, Zhou M, Li X, Li Y, Xiong W, Li G, Guo C, Zeng Z. Chronic Stress Promotes Cancer Development. Front Oncol. 2020 Aug 19;10:1492. doi: 10.3389/fonc.2020.01492. eCollection 2020.
PubMed 32974180Divani A, Heidari ME, Ghavampour N, Parouhan A, Ahmadi S, Narimani Charan O, Shahsavari H. Effect of cancer treatment on sleep quality in cancer patients: A systematic review and meta-analysis of Pittsburgh Sleep Quality Index. Support Care Cancer. 2022 Jun;30(6):4687-4697. doi: 10.1007/s00520-021-06767-9. Epub 2022 Jan 26.
PubMed 35079904Alanazi MT, Alanazi NT, Alfadeel MA, Bugis BA. Sleep deprivation and quality of life among uterine cancer survivors: systematic review. Support Care Cancer. 2022 Mar;30(3):2891-2900. doi: 10.1007/s00520-021-06589-9. Epub 2021 Sep 30.
PubMed 34595604Mitchell AJ, Ferguson DW, Gill J, Paul J, Symonds P. Depression and anxiety in long-term cancer survivors compared with spouses and healthy controls: a systematic review and meta-analysis. Lancet Oncol. 2013 Jul;14(8):721-32. doi: 10.1016/S1470-2045(13)70244-4. Epub 2013 Jun 5.
PubMed 23759376Mehnert-Theuerkauf A, Hufeld JM, Esser P, Goerling U, Hermann M, Zimmermann T, Reuter H, Ernst J. Prevalence of mental disorders, psychosocial distress, and perceived need for psychosocial support in cancer patients and their relatives stratified by biopsychosocial factors: rationale, study design, and methods of a prospective multi-center observational cohort study (LUPE study). Front Psychol. 2023 Apr 20;14:1125545. doi: 10.3389/fpsyg.2023.1125545. eCollection 2023.
PubMed 37151329McDonough AL, Lei Y, Kwak AH, Haggett DE, Jimenez RB, Johnston KT, Moy B, Spring LM, Peppercorn J. Implementation of a Brief Screening Tool to Identify Needs of Breast Cancer Survivors. Clin Breast Cancer. 2021 Feb;21(1):e88-e95. doi: 10.1016/j.clbc.2020.07.006. Epub 2020 Jul 15.
PubMed 32807644Lu SC, Porter I, Valderas JM, Harrison CJ, Sidey-Gibbons C. Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. J Patient Rep Outcomes. 2023 Jun 5;7(1):54. doi: 10.1186/s41687-023-00578-8.
PubMed 37277575Basu A, Bhattacharya S, Miller K. A pilot study of a low-intensity health education intervention on activity and quality-of-life measures for cancer survivors. Journal of Clinical Oncology 34, no. 3_suppl (2016) 221-221.
Cruz Bermudez, HF; Moreno Collazos, JE; Angarita Fonseca, A. Medición de la calidad de vida por el cuestionario QLQ-C30 en sujetos con diversos tipos de cáncer de la ciudad de Bucaramanga-Colombia. Enferm glob 2013 vol.12 nº30.
Anthoine E, Moret L, Regnault A, Sebille V, Hardouin JB. Sample size used to validate a scale: a review of publications on newly-developed patient reported outcomes measures. Health Qual Life Outcomes. 2014 Dec 9;12:176. doi: 10.1186/s12955-014-0176-2.
PubMed 25492701Chaplin A, Wordsworth J, Prohens L, Obrador-Hevia A, Guillot M, Ricci-Cabello I, Sese A, Romaguera D. Validation and pilot feasibility study of a novel screener to assess diet, lifestyle and mental health in people living with and beyond cancer: Study protocols. PLoS One. 2025 Jun 5;20(6):e0323671. doi: 10.1371/journal.pone.0323671. eCollection 2025.
PubMed 40472046
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06582498
- Acronym / sponsor ID
- LIFE S-CAN / IMP23/01
- Conditions
- Cancer Survivors
- Keywords
- Cancer survivorship, Screener, Diet, Physical activity, Psychosocial distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes BalearsOther government
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Behavioral: Active interventionConsists of participants (50% of the total recruited) which will receive the Active Intervention. |
| Low-intensity intervention | Active comparator | Behavioral: Low-intensity interventionConsists of participants (50% of the total recruited) which will receive the Low Intensity Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Ongoing cancer or cancer treatment; have a debilitating medical or psychiatric illness; presenting a disorder that compromises comprehension (e.g., dementia); pregnancy/breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active interventionThis 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. | Behavioural | Active intervention |
| Low-intensity interventionThis 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. | Behavioural | Low-intensity intervention |
Primary outcome
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
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 secondary outcomes
Changes in body composition
Time frame: 3 months
Changes in physical activity levels
Time frame: 3 months
Change in diet
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 35736631Miller KD, Nogueira L, Devasia T, Mariotto AB, Yabroff KR, Jemal A, Kramer J, Siegel RL. Cancer treatment and survivorship statistics, 2022. CA Cancer J Clin. 2022 Sep;72(5):409-436. doi: 10.3322/caac.21731. Epub 2022 Jun 23.
- Background: PubMed 21980007Parry C, Kent EE, Mariotto AB, Alfano CM, Rowland JH. Cancer survivors: a booming population. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):1996-2005. doi: 10.1158/1055-9965.EPI-11-0729.
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- Background: PubMed 29739897de Rooij BH, Park ER, Perez GK, Rabin J, Quain KM, Dizon DS, Post KE, Chinn GM, McDonough AL, Jimenez RB, van de Poll-Franse LV, Peppercorn J. Cluster Analysis Demonstrates the Need to Individualize Care for Cancer Survivors. Oncologist. 2018 Dec;23(12):1474-1481. doi: 10.1634/theoncologist.2017-0558. Epub 2018 May 8.
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- Background: PubMed 35079904Divani A, Heidari ME, Ghavampour N, Parouhan A, Ahmadi S, Narimani Charan O, Shahsavari H. Effect of cancer treatment on sleep quality in cancer patients: A systematic review and meta-analysis of Pittsburgh Sleep Quality Index. Support Care Cancer. 2022 Jun;30(6):4687-4697. doi: 10.1007/s00520-021-06767-9. Epub 2022 Jan 26.
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- BackgroundBasu A, Bhattacharya S, Miller K. A pilot study of a low-intensity health education intervention on activity and quality-of-life measures for cancer survivors. Journal of Clinical Oncology 34, no. 3_suppl (2016) 221-221.
- World Cancer Research Fund/American Institute for Cancer Research. Diet, Nutrition, Physical Activity and Cancer: a Global Perspective. Continuous Update Project Expert Report 2018.Link provided by the sponsor.
- National Comprehensive Cancer Network \[Internet\]. Survivorship Care for Healthy Living \[cited 2023 Jul 11\]. Patient resources.Link provided by the sponsor.
- American Heart Association. Life's Essential 8. Healthy Lifestyle.2023. Accessed May16, 2023.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Chaplin, PhD principal investigator
CIBER (Consorcio Investigación Biomédica en Red); IdISBa (Fundació Instituto de Investigación Sanitaria de las Islas Baleares)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active intervention and Low-intensity intervention in people with Cancer Survivors, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility in modifying Life S-Can score (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06582498, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.