NCT07582666

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

April 28, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

Self-EfficacyPosttraumatic Growth InventoryHospital Anxiety and Depression ScalePositive Affect ScheduleQuasi-Experimental DesignWaitlist ControlPsychoeducationStrengths-Based InterventionPositive PsychologyPsycho-Oncology

Outcome Measures

Primary Outcomes (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).

    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)

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

    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)

    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)

    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)

    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)

    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).

  • +1 more secondary outcomes

Study Arms (2)

Arm1: AERES Group (Immediate Intervention)

EXPERIMENTAL

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.

Behavioral: CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention

Arm 2: WL group (Waitlist Control Group)

ACTIVE COMPARATOR

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.

Behavioral: CAERES (Cancer Auto-Evaluation of RESources) Psychosocial Intervention

Interventions

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.

Also known as: CAERES Protocol
Arm 2: WL group (Waitlist Control Group)Arm1: AERES Group (Immediate Intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Istituto Oncologico della Svizzera Italiana (IOSI)

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Private Psycho-Oncology Practice

Lugano, Canton Ticino, 6900, Switzerland

Location

Clinica di Riabilitazione EOC

Novaggio, Canton Ticino, 6986, Switzerland

Location

Related Publications (10)

  • 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.

    PMID: 20467578BACKGROUND
  • 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.

    PMID: 31206917BACKGROUND
  • 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.

    PMID: 15838407BACKGROUND
  • 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.

    PMID: 23229823BACKGROUND
  • 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.

    PMID: 19582640BACKGROUND
  • 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.

    PMID: 11315248BACKGROUND
  • 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.

    PMID: 30953485BACKGROUND
  • 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.

    PMID: 22790224BACKGROUND
  • 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.

    PMID: 10335929BACKGROUND
  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

NeoplasmsDepressionAnxiety Disorders

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alexandra d'Agata Botta, MSc

    UniDistance Suisse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blind design with participant masking. Although participants were informed of their participation in a psychoeducational program and provided informed consent, the two-arm comparative structure of the study (immediate intervention vs. waitlist control) was not explicitly disclosed in the participant information. Group allocation was presented as determined by participants' oncological treatment schedules rather than as an experimental condition. This naturalistic allocation procedure ensured that participants were unaware of belonging to a comparison group, minimizing differential expectancy effects between arms.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist FSP (Federation of Swiss Psychologists), MSc in Psychology

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 13, 2026

Study Start

October 15, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 12 months after publication of main results, ending 5 years after publication.
Access Criteria
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.

Locations