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

2026年5月5日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

32

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

他の名前:
  • CAERES Protocol
アクティブコンパレータ: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.

他の名前:
  • CAERES Protocol

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
CAERES Questionnaire (Acceptability and Feasibility Multi-Domain Assessment)
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient Satisfaction with Chronic Illness Care (PACIC-5A)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Alexandra d'Agata Botta, MSc、UniDistance Suisse

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年10月15日

一次修了 (実際)

2022年5月31日

研究の完了 (実際)

2022年5月31日

試験登録日

最初に提出

2026年4月28日

QC基準を満たした最初の提出物

2026年5月5日

最初の投稿 (実際)

2026年5月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月13日

QC基準を満たした最後の更新が送信されました

2026年5月5日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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).

IPD 共有時間枠

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

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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