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临床试验/NCT07582666
NCT07582666已完成不适用

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

UniDistance Suisse3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
3

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
UniDistance Suisse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra d'Agata Botta

Psychologist FSP (Federation of Swiss Psychologists), MSc in Psychology

UniDistance Suisse

研究点 (3)

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