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Completed

NCT Number: NCT07582666

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona, Canton Ticino, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention

Behavioral

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.

Other names: CAERES Protocol

Primary outcomes

  1. CAERES Questionnaire (Acceptability and Feasibility Multi-Domain Assessment)

    Time frame: 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).

Secondary outcomes

  1. Patient Satisfaction with Chronic Illness Care (PACIC-5A)

    Time frame: 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).

  2. Positive Affect (PANAS Positive Subscale)

    Time frame: 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).

  3. Cancer-Related Self-Efficacy for Coping (CBI-B/I)

    Time frame: 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).

  4. Posttraumatic Growth (PTGI-SF, Italian Version)

    Time frame: 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).

  5. Cancer-Related Fatigue (BFI-I, Italian Version)

    Time frame: 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).

  6. Anxiety and Depression (HADS, Italian Version)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

UniDistance Suisse

Other

Registry information

Official study title

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

Acronym: CAERES

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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