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

NCT06582498 | Enrolling By Invitation

• 1 other identifier: IMP23/01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivors

Keywords

Cancer survivorship; Screener; Diet; Physical activity; Psychosocial distress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in body composition

  3 months

• Changes in physical activity levels

  3 months

• Change in diet

  3 months

Other Outcomes (3)

• Screener validation

  3 months

• Reproducibility of the Life S-can screener

  10 days

• Qualitative study

  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.

Study Arms (2)

Active intervention

EXPERIMENTAL

Consists of participants (50% of the total recruited) which will receive the Active Intervention.

Behavioral: Active intervention

Low-intensity intervention

ACTIVE COMPARATOR

Consists of participants (50% of the total recruited) which will receive the Low Intensity Intervention.

Behavioral: Low-intensity intervention

Interventions

Active intervention BEHAVIORAL

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 intervention

Low-intensity intervention BEHAVIORAL

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.

Low-intensity intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead

Study Sites (1)

Fundació Instituto de Investigación Sanitaria de las Islas Baleares (IDISBA)

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Related Publications (15)

• 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.

  PMID: 35736631 BACKGROUND

• Parry 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.

  PMID: 21980007 BACKGROUND

• Jefford 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.

  PMID: 35430022 BACKGROUND

• de 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.

  PMID: 29739897 BACKGROUND

• Dai 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.

  PMID: 32974180 BACKGROUND

• Divani 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.

  PMID: 35079904 BACKGROUND

• Alanazi 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.

  PMID: 34595604 BACKGROUND

• Mitchell 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.

  PMID: 23759376 BACKGROUND

• Mehnert-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.

  PMID: 37151329 BACKGROUND

• McDonough 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.

  PMID: 32807644 BACKGROUND

• Lu 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.

  PMID: 37277575 BACKGROUND

• Basu 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25492701 BACKGROUND

• Chaplin 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.

  PMID: 40472046 DERIVED

Related Links

• World Cancer Research Fund/American Institute for Cancer Research. Diet, Nutrition, Physical Activity and Cancer: a Global Perspective. Continuous Update Project Expert Report 2018.
• National Comprehensive Cancer Network \[Internet\]. Survivorship Care for Healthy Living \[cited 2023 Jul 11\]. Patient resources.
• American Heart Association. Life's Essential 8. Healthy Lifestyle.2023. Accessed May16, 2023.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Alice Chaplin, PhD

  CIBER (Consorcio Investigación Biomédica en Red); IdISBa (Fundació Instituto de Investigación Sanitaria de las Islas Baleares)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 3, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)