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Self EfficacyCAERESNCT07582666

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

A study testing CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention in people with Self Efficacy and Neoplasms (Cancer / Tumors), run by UniDistance Suisse at 3 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
3 sitesSwitzerland
Study dates
15 Oct 2021to 31 May 2022
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • Istituto Oncologico della Svizzera Italiana (IOSI)

    Bellinzona, Canton Ticino, 6500

  • Private Psycho-Oncology Practice

    Lugano, Canton Ticino, 6900

  • Clinica di Riabilitazione EOC

    Novaggio, Canton Ticino, 6986

Other trials in Switzerland

About this study

Official 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

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.

Read more

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.

Read the detailed description

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.

Being tested
CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention
Keywords
Self-Efficacy, Posttraumatic Growth Inventory, Hospital Anxiety and Depression Scale, Positive Affect Schedule, Quasi-Experimental Design, Waitlist Control, Psychoeducation, Strengths-Based Intervention, Positive Psychology, Psycho-Oncology
Medical subject headings
Neoplasms, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAERES (Cancer Auto-Evaluation of RESources) Psychosocial InterventionBehavioural

    Also called CAERES Protocol

    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.

Study groups in NCT07582666
Study groupRoleWhat they receive
Arm1: AERES Group (Immediate Intervention)ExperimentalAdult 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.
Receives: Behavioral: CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention
Arm 2: WL group (Waitlist Control Group)Active comparatorAdult 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.
Receives: Behavioral: CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

    Measured: 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.

Secondary outcomes (6)

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

    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).

    Measured: 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).

  2. Positive Affect (PANAS Positive Subscale)

    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).

    Measured: 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).

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

    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).

    Measured: 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).

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

    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).

    Measured: 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).

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

    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).

    Measured: 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).

  6. Anxiety and Depression (HADS, Italian Version)

    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).

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start15 Oct 2021
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Parallel-group design with two arms: an immediate intervention group (Arm 1: AERES group) and a waitlist (WL) control group (Arm 2 : WL group) that received the same intervention after a 3-week delay. Group allocation was non-randomized and based on participants' scheduling availability.
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07582666
Sponsor's protocol ID
BASEC-2021-01759
Other IDs
CE3941
Acronym
CAERES
Status last verified
May 2026
First submitted
28 Apr 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Terracciano A, McCrae RR, Costa PT Jr. Factorial and construct validity of the Italian Positive and Negative Affect Schedule (PANAS). Eur J Psychol Assess. 2003;19(2):131-141. doi: 10.1027//1015-5759.19.2.131.

    PubMed 20467578

  • Merluzzi TV, Pustejovsky JE, Philip EJ, Sohl SJ, Berendsen M, Salsman JM. Interventions to enhance self-efficacy in cancer patients: A meta-analysis of randomized controlled trials. Psychooncology. 2019 Sep;28(9):1781-1790. doi: 10.1002/pon.5148. Epub 2019 Jul 9.

    PubMed 31206917

  • Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005 May;43(5):436-44. doi: 10.1097/01.mlr.0000160375.47920.8c.

    PubMed 15838407

  • Ruini C, Vescovelli F, Albieri E. Post-traumatic growth in breast cancer survivors: new insights into its relationships with well-being and distress. J Clin Psychol Med Settings. 2013 Sep;20(3):383-91. doi: 10.1007/s10880-012-9340-1.

    PubMed 23229823

  • Cann A, Calhoun LG, Tedeschi RG, Taku K, Vishnevsky T, Triplett KN, Danhauer SC. A short form of the Posttraumatic Growth Inventory. Anxiety Stress Coping. 2010;23(2):127-37. doi: 10.1080/10615800903094273.

    PubMed 19582640

  • Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. doi: 10.1037//0003-066x.56.3.218.

    PubMed 11315248

  • Serpentini S, Del Bianco P, Chirico A, Merluzzi TV, Martino R, Lucidi F, De Salvo GL, Trentin L, Capovilla E. Self-efficacy for coping: utility of the Cancer behavior inventory (Italian) for use in palliative care. BMC Palliat Care. 2019 Apr 5;18(1):34. doi: 10.1186/s12904-019-0420-y.

    PubMed 30953485

  • Catania G, Bell C, Ottonelli S, Marchetti M, Bryce J, Grossi A, Costantini M. Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI). Support Care Cancer. 2013 Feb;21(2):413-9. doi: 10.1007/s00520-012-1539-z. Epub 2012 Jul 13.

    PubMed 22790224

  • Costantini M, Musso M, Viterbori P, Bonci F, Del Mastro L, Garrone O, Venturini M, Morasso G. Detecting psychological distress in cancer patients: validity of the Italian version of the Hospital Anxiety and Depression Scale. Support Care Cancer. 1999 May;7(3):121-7. doi: 10.1007/s005200050241.

    PubMed 10335929

  • Bellier-Teichmann T, Golay P, Pomini V. Which are your resources and how do they contribute to your recovery? A new strengths assessment within a clinical population. European Review of Applied Psychology. 2018;68(6):215-226. doi: 10.1016/j.erap.2018.10.004

Questions about this trial

What is this clinical trial studying?

A study testing CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention in people with Self Efficacy and Neoplasms (Cancer / Tumors), run by UniDistance Suisse at 3 sites in Switzerland.

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 6 inclusion and 6 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. 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?

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.). 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 NCT07582666, which also lists 10 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 13 May 2026.

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