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Identifying and Mobilizing Personal Resources to Improve Well-Being in Cancer Participants Using the CAERES Protocol (CAERES)

5 maja 2026 zaktualizowane przez: Alexandra d'Agata Botta, UniDistance Suisse

A Resource-Based Psychological Intervention to Enhance Well-Being in Cancer Participants: Acceptability, Feasibility and Effects of the CAERES Protocol (Cancer Auto-Evaluation of RESources) - A Pilot Study in Italian-Speaking Switzerland

Cancer patients often experience emotional distress, fatigue, and reduced quality of life that may not be fully addressed by medical treatment alone. Research suggests that helping patients identify and mobilize their personal strengths and resources may support their psychological well-being. However, structured psychosocial interventions focused on personal resources have not been widely tested in cancer rehabilitation settings.

The goal of this clinical trial was to test the acceptability and feasibility of a 3-week psychosocial intervention designed to help adult cancer patients identify and mobilize their personal strengths to better cope with their illness. The intervention was based on the AERES tool (Auto-Evaluation des RESsources; in english : Resources Self-Assessment), a card-sorting instrument developed at the University of Lausanne for strength-based assessment in clinical populations.

The main questions it aimed to answer were:

  • Was the CAERES (Cancer Auto-Evaluation of RESources) intervention acceptable and feasible for cancer patients undergoing oncological treatment or rehabilitation?
  • Did the intervention positively affect emotional well-being, self-efficacy, posttraumatic growth, cancer-related fatigue, anxiety, depression, and satisfaction with care?

Researchers compared an immediate-intervention group with a waitlist control group (3-week delay before receiving the same intervention) to see if the intervention produced measurable effects on the targeted outcomes.

Participants:

  • Completed an in-person AERES card-sorting session (1 to 2.5 hours) to identify personal strengths across three dimensions (personal qualities, hobbies and passions, and social/environmental resources)
  • Received a personalized written report identifying a targeted resource to develop
  • Engaged in a 3-week home-based reinforcement program with three weekly phone calls (15 minutes each) and three personalized written feedback reports
  • Completed validated questionnaires at three time points (baseline, post-intervention, follow-up)

Recruitment was conducted at three sites in Italian-speaking Switzerland: the Rehabilitation Clinic of Novaggio (EOC/Ente Ospedaliero Cantonale), the Oncology Institute of Southern Switzerland (IOSI) in Bellinzona, and a private psycho-oncology practice in Lugano, with patient referrals supported by collaborating psycho-oncologists.

Przegląd badań

Szczegółowy opis

The CAERES protocol uses the Auto-Evaluation of RESources (AERES) tool, a standardized card-sorting instrument originally developed by Bellier-Teichmann and Pomini (2015) for psychiatric populations, and subsequently validated as a strengths assessment tool in clinical populations (Bellier-Teichmann, Golay & Pomini, 2018). This study represented the first adaptation of the AERES tool to oncology.

The AERES tool comprises 31 illustrated cards organized into three dimensions: personal qualities and characteristics (11 cards, including courage, gratitude, humor, perseverance), hobbies and passions (10 cards, including cooking, reading, physical activities, music), and social and environmental resources (10 cards, including family, friends, nature, healthcare professionals), plus 3 blank cards allowing individualized additions. The card-sorting procedure involves three successive sorts: participants first identify which resources are present in their lives, then evaluate each resource's contribution to their recovery on a 4-point scale, and finally select resources they wish to develop or strengthen during the reinforcement period. The AERES tool has demonstrated good psychometric properties in previous research and provides a structured, visual method for engaging participants in a strengths-based assessment that does not rely on traditional questionnaire formats.

Following the AERES card-sorting session, the investigator prepared a personalized written report identifying the targeted resource selected by the participant for development. This report was the basis for a 3-week home-based reinforcement program in which the participant engaged with the targeted resource through self-directed exercises and reflection.

During the reinforcement program, three weekly contacts were structured: at the end of each week, a 15-minute phone call took place between the investigator and the participant to gather feedback on the past week's experience. Each phone call was followed by a personalized written feedback report sent to the participant to support their progress and reinforce engagement with the targeted resource.

The intervention used a multimodal communication approach adapted to participant preferences and circumstances. Written reports and questionnaires were delivered through email, postal mail, or in-person delivery, depending on what was most accessible and comfortable for each participant. This pragmatic flexibility reflected the real-world conditions of oncological care in Italian-speaking Switzerland and aimed at maximizing participant retention.

A quasi-experimental waitlist control design was adopted because random allocation was not feasible given the recruitment constraints across the three sites. Participants were allocated to either an immediate-intervention arm or a waitlist control arm based on the timing of their entry into the study and their treatment scheduling. The waitlist control group received the same intervention after a 3-week delay, allowing for within-subject comparison and a partial control for time effects. This design preserved the pragmatic feasibility of the study in a real-world oncological setting while maintaining a comparison condition.

Outcome assessments were conducted at three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for the immediate-intervention group, end of waiting period for the waitlist control group), and at 6 weeks after baseline (end of study, after the waitlist control group had also completed the intervention). All measures were administered in Italian, and adaptations to recall periods were made for some instruments to align with the 3-week intervention timeline.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

32

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Canton Ticino
      • Bellinzona, Canton Ticino, Szwajcaria, 6500
        • Istituto Oncologico della Svizzera Italiana (IOSI)
      • Lugano, Canton Ticino, Szwajcaria, 6900
        • Private Psycho-Oncology Practice
      • Novaggio, Canton Ticino, Szwajcaria, 6986
        • Clinica di Riabilitazione EOC

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Any type of cancer
  • Age ≥18 years
  • Currently undergoing or awaiting curative cancer treatment (chemotherapy, radiotherapy, and/or surgery), or in oncological rehabilitation/follow-up
  • Life expectancy of at least one year
  • Sufficient knowledge of Italian or French
  • Written informed consent provided

Exclusion Criteria:

  • Treatment completed more than two years prior to enrollment
  • Advanced disease
  • Cancer relapse during the study
  • Diagnosis of major depression
  • Cognitive impairment preventing adequate adherence to the protocol
  • Insufficient knowledge of Italian or French to participate in counseling and assessment sessions

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Arm1: AERES Group (Immediate Intervention)
Adult cancer patients receiving the CAERES psychosocial intervention immediately after baseline assessment. The 3-week intervention combines: (1) an initial in-person AERES assessment session (1.5-2.5 hrs) using a card-based tool to identify personal strengths and resources, followed by an initial personalized written report specifying the targeted resource to mobilize; (2) three weekly follow-up phone calls, each followed by a personalized written report. Outcomes assessed at baseline (pre-test, before any intervention), at 3 weeks after baseline (post-test 1, immediately after intervention completion), and at 6 weeks after baseline (post-test 2, end of study). Written materials and self-report questionnaires were delivered by email, postal mail, or in person, according to participant preference.

The CAERES intervention is a multi-component, individualized psychosocial program enhancing personal resource mobilization, self-efficacy, and psychological well-being in cancer patients. Hybrid format over 3 weeks, with two phases:

PHASE 1 - Initial in-person AERES assessment session (1.5-2.5 hrs) using card-based tool (Bellier-Teichmann & Pomini, 2015) to identify personal strengths and resources; followed by an initial personalized written report specifying the targeted resource to mobilize.

PHASE 2 - Three-week reinforcement program: three structured weekly cycles, each consisting of an individual phone call supporting active mobilization of the targeted resource, followed by a personalized written report.

Total: 8 structured contacts (1 in-person session, 3 phone calls, 4 written reports). Written reports and self-report questionnaire batteries were delivered to participants by email, postal mail, or in person, according to participant preference.

Inne nazwy:
  • CAERES Protocol
Aktywny komparator: Arm 2: WL group (Waitlist Control Group)
Adult cancer patients placed on a 3-week waiting list before receiving the same CAERES psychosocial intervention as Arm 1 (initial in-person AERES session, initial personalized written report, three weekly phone calls each followed by a personalized written report). Outcomes assessed at baseline (pre-test 1, before any intervention), at 3 weeks after baseline (pre-test 2, end of waiting period), and at 6 weeks after baseline (post-test, immediately after delayed intervention completion). Written materials and self-report questionnaires were delivered by email, postal mail, or in person, according to participant preference. Group allocation was non-randomized, based on participants' availability and compatibility with oncological treatment schedule.

The CAERES intervention is a multi-component, individualized psychosocial program enhancing personal resource mobilization, self-efficacy, and psychological well-being in cancer patients. Hybrid format over 3 weeks, with two phases:

PHASE 1 - Initial in-person AERES assessment session (1.5-2.5 hrs) using card-based tool (Bellier-Teichmann & Pomini, 2015) to identify personal strengths and resources; followed by an initial personalized written report specifying the targeted resource to mobilize.

PHASE 2 - Three-week reinforcement program: three structured weekly cycles, each consisting of an individual phone call supporting active mobilization of the targeted resource, followed by a personalized written report.

Total: 8 structured contacts (1 in-person session, 3 phone calls, 4 written reports). Written reports and self-report questionnaire batteries were delivered to participants by email, postal mail, or in person, according to participant preference.

Inne nazwy:
  • CAERES Protocol

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
CAERES Questionnaire (Acceptability and Feasibility Multi-Domain Assessment)
Ramy czasowe: At end of study, 6 weeks after baseline: 3 weeks after intervention completion for the AERES Group, and immediately after intervention completion for the Waitlist Control Group. Measured once per participant.
Acceptability and feasibility of the CAERES psychosocial intervention assessed using the CAERES questionnaire, a 56-item self-developed instrument administered once at end of study (6 weeks after baseline). The questionnaire is structured in 7 domains corresponding to the intervention components: overall protocol design (Q1); initial AERES self-assessment session (Q2); initial written report (Q3); 3-week reinforcement program (Q4); three weekly phone calls (Q5); three weekly written feedback reports (Q6); three outcome assessment batteries (Q7). Each domain is rated through 8 evaluative items on a 5-point Likert scale (1=strongly disagree to 5=strongly agree): relevant, stimulating, interesting, innovative, pleasant, organized, individualized, and demanding (reverse-scored). A global score is computed by summing the 7 domain mean scores (range 7-35). Higher scores indicate greater acceptability/feasibility. Internal consistency: Cronbach's alpha = .91 (n=30, 7 domains).
At end of study, 6 weeks after baseline: 3 weeks after intervention completion for the AERES Group, and immediately after intervention completion for the Waitlist Control Group. Measured once per participant.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient Satisfaction with Chronic Illness Care (PACIC-5A)
Ramy czasowe: Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Patient satisfaction with the structure of chronic illness care assessed using the Italian version of the Patient Assessment of Chronic Illness Care 5A (PACIC-5A; Glasgow et al., 2005), an extended 26-item version of the original PACIC (Glasgow et al., 2005). Items are rated on a 5-point Likert scale (1=almost never to 5=almost always). The instrument comprises five subscales reflecting the Chronic Care Model: patient activation (3 items), delivery system/practice design (3 items), goal setting/tailoring (5 items), problem solving/contextual (4 items), and follow-up/coordination (5 items). The original recall period (past 6 months) was adapted to refer specifically to the CAERES intervention received during the past 4 weeks. Higher scores indicate that the perceived chronic care is more structured and aligned with the Chronic Care Model. Internal consistency in original validation: Cronbach's alpha > 0.90 (Glasgow et al., 2005).
Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Positive Affect (PANAS Positive Subscale)
Ramy czasowe: Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Positive affect assessed using the 10-item Positive Affect (PA) subscale of the Italian version of the Positive and Negative Affect Schedule (PANAS; Terracciano, McCrae & Costa, 2003), validated from the original English PANAS (Watson, Clark & Tellegen, 1988). Only the 10 positive affect items of the full 20-item PANAS were administered (items 1, 3, 5, 9, 10, 12, 14, 16, 17, 19): interested, excited, strong, enthusiastic, proud, alert, inspired, determined, attentive, active. Participants rate the extent to which they experienced each adjective during the past week on a 5-point Likert scale (1=very slightly or not at all to 5=extremely). The total Positive Affect score is the sum of the 10 items (range 10-50). Higher scores indicate higher positive affect. Internal consistency in original Italian validation: Cronbach's alpha = .90 (Terracciano et al., 2003).
Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Cancer-Related Self-Efficacy for Coping (CBI-B/I)
Ramy czasowe: Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Cancer-related self-efficacy for coping assessed using the Italian version of the Cancer Behavior Inventory-Brief (CBI-B/I; Serpentini et al., 2019), validated from the original English CBI-B (Heitzmann et al., 2011). The instrument comprises 12 items rated on a 9-point Likert-type scale (1=not at all confident to 9=totally confident), measuring patients' confidence in performing specific coping behaviors related to cancer disease management. The CBI-B/I has a four-factor structure: Maintaining Independence and Positive Attitude, Coping with Stress, Managing Affect, and Participating in Medical Care. A composite self-efficacy score is computed by summing all 12 items (range 12-108). Higher scores indicate higher self-efficacy for coping with cancer. Internal consistency in original Italian validation: Cronbach's alpha = .86 for the composite score (Serpentini et al., 2019; sample of 216 advanced cancer patients in palliative care).
Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Posttraumatic Growth (PTGI-SF, Italian Version)
Ramy czasowe: Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Posttraumatic growth assessed using the Italian validation (Ruini et al., 2013) of the Short Form of the Posttraumatic Growth Inventory (PTGI-SF; Cann et al., 2010), itself derived from the original 21-item PTGI (Tedeschi & Calhoun, 1996). The PTGI-SF comprises 10 items rated on a 6-point Likert scale (0=I did not experience this change at all as a result of my cancer to 5=I experienced this change to a very strong degree as a result of my cancer). The instrument has a five-factor structure with two items per subscale: New Possibilities, Relating to Others, Personal Strength, Spiritual Change, and Appreciation of Life. A total PTGI-SF score is computed by summing the 10 items (range 0-50). Higher scores indicate greater perceived positive psychological change as a result of the cancer experience. Internal consistency in published Italian validations: Cronbach's alpha > .87 (Ruini et al., 2013; Cordova et al., 2001; Porro et al., 2022).
Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Cancer-Related Fatigue (BFI-I, Italian Version)
Ramy czasowe: Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Cancer-related fatigue assessed using the Italian version of the Brief Fatigue Inventory (BFI-I; Catania et al., 2013), validated from the original BFI (Mendoza et al., 1999). The instrument comprises one initial dichotomous screening item followed by 9 items rated on an 11-point numerical scale (0=no fatigue/does not interfere to 10=fatigue as bad as you can imagine/completely interferes). Three items assess fatigue intensity (worst, usual, current) and six items assess interference with daily activities (general activity, mood, walking, normal work, relations with others, enjoyment of life). The recall period was adapted from the standard 24-hour reference to "the past week" to align with the 3-week intervention timeline. The total score is the mean of the 9 items (range 0-10). Higher scores indicate higher cancer-related fatigue. Internal consistency in original Italian validation: Cronbach's alpha = .94 (Catania et al., 2013).
Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Anxiety and Depression (HADS, Italian Version)
Ramy czasowe: Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).
Anxiety and depression assessed using the Italian validation (Costantini et al., 1999) of the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983), a 14-item self-report instrument widely used to detect psychological distress in non-psychiatric clinical settings, including oncology. Items are rated on a 4-point Likert scale (0 to 3), referring to symptoms experienced during the past week. The instrument comprises two 7-item subscales: HADS-Anxiety and HADS-Depression, each yielding a subscale score ranging from 0 to 21. A total HADS score (range 0-42) provides an overall measure of psychological distress. Higher scores indicate higher levels of anxiety, depression, or overall distress. Cut-off ≥10 on the total score indicates probable psychiatric distress. Internal consistency in original Italian validation: Cronbach's alpha = .80-.85 for subscales and .88-.89 for total score (Costantini et al., 1999, n=197 breast cancer patients).
Three measurement time points: at baseline (before any intervention), at 3 weeks after baseline (post-intervention for AERES Group / end of waiting period for Waitlist Control Group), and at 6 weeks after baseline (end of study).

Współpracownicy i badacze

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Śledczy

  • Główny śledczy: Alexandra d'Agata Botta, MSc, UniDistance Suisse

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 października 2021

Zakończenie podstawowe (Rzeczywisty)

31 maja 2022

Ukończenie studiów (Rzeczywisty)

31 maja 2022

Daty rejestracji na studia

Pierwszy przesłany

28 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Anonymized individual participant data (IPD) supporting the published results will be made available upon reasonable request to qualified researchers, in accordance with the informed consent obtained from participants (which explicitly authorized data sharing with other researchers in coded form, and the optional reuse of coded data for future medical research). Data sharing will exclude any direct or indirect identifiers to protect participant privacy. Requests should be addressed to the principal investigator and will be evaluated based on scientific merit and ethical considerations. Data are stored in compliance with Swiss data protection standards (LPD).

Ramy czasowe udostępniania IPD

Beginning 12 months after publication of main results, ending 5 years after publication.

Kryteria dostępu do udostępniania IPD

Researchers with a methodologically sound proposal demonstrating scientific merit and ethical considerations may submit requests to the principal investigator. Approval will be granted following review of the proposal and signature of a data access agreement.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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