Efficacy of a Brief Intervention for Female Breast CANcer Based on Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain: A 2-Arm Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in the Functional Assessment of Cancer Therapy - Breast (FACT-B; Brady et al., 1997)
研究概览
简要总结
As a result of the cancer diagnosis and medical therapies, women with breast cancer often encounter debilitating cooccurring psychological and physical symptoms. While pain constitutes one of the most common adverse physical side effects of medical treatment reported by breast cancer patients, the most prevalent psychological symptom they seek psychological help for is depressive symptoms. Acceptance and Commitment Therapy (ACT) in psychosocial oncology care may be particularly beneficial in targeting depression and cancer-related pain. The aim of the I-CAN-ACT project is to examine in a RCT the efficacy of a brief ACT-based intervention for both depression and physical pain (6 online sessions) compared to a waitlist control on various outcomes in women with breast cancer. Outcomes will include quality of life, physical pain intensity and interference, depression, and anxiety in women with breast cancer. These will be assessed at post-treatment and at the 1-month, 3-month, 6-month and 1 year follow-ups (for Marianna Zacharia's PhD thesis, results will be presented until the 3-month follow-up). Also, the Acceptability and Feasibility of the intervention will be assessed. That is, participants' treatment acceptability and adherence to the brief ACT intervention in terms of retention, treatment engagement and satisfaction with each session and with the overall treatment will be assessed. Participants' reasons for dropout will be recorded.
详细描述
As a result of the cancer diagnosis and medical therapies, women with breast cancer often encounter debilitating cooccurring psychological and physical symptoms. While pain constitutes one of the most common adverse physical side effects of medical treatment reported by breast cancer patients, the most prevalent psychological symptom they seek psychological help for is depressive symptoms. Acceptance and Commitment Therapy (ACT) in psychosocial oncology care may be particularly beneficial in targeting depression and cancer-related pain. The aim of the I-CAN-ACT project is to examine in a RCT the efficacy of a brief ACT-based intervention for both depression and physical pain (6 online sessions) compared to a waitlist control on various outcomes in women with breast cancer.
Based on preliminary empirical findings, the hypotheses of this study are:
- The group ACT-based intervention will demonstrate significantly greater improvements in the primary outcome (quality of life: physical well-being, emotional well-being, social/family well-being, functional well-being, additional concerns for breast cancer) compared to the WL at post-treatment, at 1-month and 3-month follow-ups.
- The group ACT-based intervention will demonstrate significantly greater reductions in the secondary outcomes (pain intensity and interference, depression and anxiety) compared to the WL at post-treatment, at 1-month and 3-month follow-ups.
- The group ACT-based intervention will present significant improvements in the ACT components (acceptance, cognitive defusion, contact with the present moment, self-as-context, self-compassion, values clarification, committed action) compared to the WL at post-treatment, at 1-month and 3-month follow-ups.
- It is hypothesized that the mechanisms/core processes, via which ACT is expected to exert its effects, will mediate pre to 1-month follow-up and pre to 3-month follow-up quality of life scores (primary outcome) for the ACT-based intervention.
- It is hypothesized that the mechanisms/core processes, via which ACT is expected to exert its effects, will mediate pre to 1-month follow-up and pre to 3-month follow-up scores of secondary outcomes (physical pain intensity and interference, depression, anxiety).
- Completing any ACT skill in a session will lead to improvement in that specific skill (ACT proposed mechanism of action) in-the-moment within each week of the group ACT-based intervention.
This is the first study to:
i. examine the longitudinal effects (1-month and 3-month follow ups) of an ACT intervention on both depression and physical pain, which often co-occur in female breast cancer patients ii. examine all the processes of change in ACT responsible for effective treatment outcomes in women with breast cancer iii. offer a brief ACT intervention for this population iv. assess participants' treatment acceptability and adherence to an ACT-based intervention in terms of retention, treatment engagement and satisfaction with treatment for this population v. assess therapists' fidelity/adherence to the protocol and the ACT approach as well as the therapists' competence, when implementing a RCT for women with breast cancer vi. employ the innovative methodological approach of Ecological Momentary Assessment through a mobile application in addition to standardized pre post-follow-up self-report questionnaires to assess changes in the ACT processes as a result of intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Understanding and speaking fluently in Greek
- •Age 18 and older
- •Education level should be at least elementary school (ability to read and write)
- •Diagnosed breast cancer in stages I, II or III
- •Underwent breast surgery
- •Experiencing at least mild depression and at least mild intensity and interference of physical pain
排除标准
- •A history of metastasis (stage IV cancer)
- •Significant cognitive impairment assessed using the Mini-mental State Examination (MMSE score < 20)
- •A history of severe psychopathology (i.e., psychosis), suicidal ideation, substance use problems before breast cancer
结局指标
主要结局
Change in the Functional Assessment of Cancer Therapy - Breast (FACT-B; Brady et al., 1997)
时间窗: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
It consists of five well-being domains: physical well-being (7 items), emotional well-being (6 items), social/family well-being (7 items) and functional well-being (7 items), which constitute the Functional Assessment of Cancer Therapy - General (FACT-G; Cella et al., 1993) and the additional concerns for breast cancer, the Breast Cancer Subscale (BCS; 10 items). Each item on the FACT-B is rated on a five-point scale ranging from 0 = "not at all" to 4 = "very much". The total score can range from 0 to 144 and is the sum of scores from all five subscales. Higher scores reveal greater perceived quality of life.
次要结局
- Change in the Brief Pain Inventory (BPI; Cleeland, 1989)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
- Change in the Greek Acceptance and Action Questionnaire - II (AAQ-II; Greek version: Karekla & Michaelides, 2017; English version: Bond et al., 2011)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
- Change in the Cognitive Fusion Questionnaire (CFQ; Greek version: Zacharia et al., 2021; English version; Gillanders et al., 2014)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
- Change in the Hospital Anxiety and Depression Scale (HADS; Greek version: Mystakidou et al., 2004 and Michopoulos et al., 2008; English version: Zigmond & Snaith, 1983)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
- Change in the Valuing Questionnaire (VQ; Smout, Davies, Burns, & Christie, 2014)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
- Change in the Committed Action Questionnaire (CAQ; McCracken et al., 2015)(pre-treatment, mid-intervention assessment, post-treatment, 1-month follow-up, 3-month follow-up)
- Change in the Psyflex (Gloster et al., 2021)(A mobile application will be used, which will prompt the patients in the ACT intervention to answer the eight items of the PsyFlex. These prompts will take place twice per day for the six weeks of the intervention (Ecological Momentary Assessment).)
- Change in the Self-Compassion Scale (SCS; English version: Neff, 2003; Greek version: Mantzios, Wilson, & Giannou, 2015)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
- Change in the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman, Hayes, Kumar, Greeson, & Laurenceau, 2007)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
- Change in the Self-as-Context Scale (SACS; Zettle et al., 2018)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
- Change in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue (EORTC QLQ-FA12; Weis et al., 2017)(pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up)
研究者
Maria Karekla
Associate Professor
University of Cyprus