Acceptance and Commitment Therapy (ACT) Versus Cognitive Behavioural Therapy (CBT) for Fear of Cancer Recurrence (FCR) in Cancer Survivors and Their Spouses (CARE-Pilot)
Coping With Fear of Cancer Recurrence (CARE-pilot): Acceptance and Commitment Therapy (ACT) Versus Cognitive Behavioural Therapy (CBT) for Fear of Cancer Recurrence (FCR) in Cancer Survivors and Their Spouses: a 2-arm Randomized Controlled Feasibility Trial
Fear of cancer recurrence (FCR) is one of the most significant psychological burdens faced by cancer survivors. FCR describes the fear, worry, or concern relating to the possibility that cancer will come back or progress, and is associated with reduced quality of life as well as other psychological symptoms. Approximately 60% of cancer survivors suffer from FCR, 20% of whom suffer from severe FCR. Relatives are also burdened by FCR, which in turn negatively affects the dyadic relationship as well as the survivors' quality of life. However, to date, there is a lack of evidence-based psycho-oncological couple interventions that focus on patients'/survivors' and spouses' FCR. Meta-analyses indicate the efficacy of mindfulness- and acceptance-based approaches such as acceptance and commitment therapy (ACT) for reducing FCR. In contrast to traditional Cognitive Behavioral Therapy (CBT) approaches, which, for instance, aim to change thoughts and feelings by cognitive restructuring, ACT aims to increase psychological flexibility and promotes a more detached, acceptance-based attitude toward thoughts and feelings, as well as a value-based life orientation. However, the empirical evidence for ACT in relation to FCR still needs to be investigated more thoroughly.
This study, coping with fear of cancer recurrence (CARE-pilot), addresses these research gaps and aims to test the feasibility and preliminary efficacy of a manualized ACT couple intervention for outpatient cancer survivors (defined as cancer patients who completed primary treatment and were diagnosed < 5 years ago) and their spouses. Sixty-four couples in which either survivor, spouse or both have elevated FCR will be randomized to either the ACT couple intervention (IG) or the traditional CBT couple intervention (active control group, CG). The IG and CG interventions consist of six psychotherapy sessions (four couple sessions and two individual sessions), the content of which is intensified in online modules between sessions (blended care). The primary endpoint of the feasibility study is the retention rate and achievement of recruitment targets. Using standardized measurements, changes in FCR, quality of life (primary endpoint of preliminary efficacy), and other psychosocial variables will be assessed at post-intervention and 3 months after the end of the intervention.
The feasibility study represents the first step in evaluating the feasibility and the practicality of the couple interventions. The CARE-Pilot study aims to evaluate the feasibility and preliminary efficacy of an ACT-based couple intervention in reducing FCR, compared to a CBT-based couple intervention, in couples navigating cancer survivorship.
研究概览
详细说明
Introduction: Fear of cancer recurrence (FCR) is one of the most significant psychological burdens faced by cancer survivors and their romantic partners. However, to date, there is a lack of evidence-based psycho-oncological couple interventions that focus on patients'/survivors' and spouses' FCR. Therefore, this multicenter feasibility trial aims to test the feasibility and preliminary efficacy of a manualized ACT couple intervention for outpatient cancer survivors and their spouses compared with a CBT couple intervention.
Methods and analysis: This is a prospective, multicenter, randomized, controlled pilot trial comparing an ACT couple intervention with a CBT couple intervention. The sample will consist out of adult cancer survivors with a confirmed ICD-10 diagnosis of any cancer site after completed primary oncological treatment and their intimate partners. Time since diagnosis of survivors is <5 years. Survivors and/or their partner will suffer from elevated FCR. The investigators aim to include n = 64 dyads within two German comprehensive cancer centers.
ACT and CBT couple intervention will be delivered by clinical psychologists face-to-face or per video sessions, consisting of six sessions (four couple sessions, two individual sessions). For both trial conditions, online content (e.g. exercises or readings) will be available to deepen session content.
Primary outcomes will be feasibility parameters (retention and recruiting rate) and preliminary efficacy (FCR of survivors and partners). Secondary outcomes will be further feasibility variables (satisfaction with the intervention, treatment fidelity) as well as psychological parameters (e.g. QoL, psychological burden), and dyadic and somatic parameters (e.g. dyadic coping, symptom interference). Explorative outcomes are ACT-based (e.g. psychological flexibility, acceptance, value-based living). The feasibility study represents the first step in evaluating the feasibility and the practicality of the couple interventions in preparation of a full power multicenter RCT. Due to its dyadic approach, our ACT couple intervention has the potential to expand the range of psychological treatment options with ecological valid treatment for reducing FCR.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Christina Sauer, PD Dr.
- 电话号码：049 69 6301 84904
- 邮箱：c.sauer@med.uni-frankfurt.de
研究联系人备份
- 姓名：Gregor Weissflog, Dr.
- 邮箱：gregor.weissflog@medizin.uni-leipzig.de
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Patients
- cancer survivors (male/female/diverse) with any cancer entity
- after completed primary treatment (not including endocrine treatment, which can be ongoing)
- < five years after primary diagnosis
- FCR (FoP-Q-SF total score ≥ 34) or spouses' FCR (FoP-Q-SF/P total score ≥ 34)
- living in a partnership or marriage (homo- or heterosexual, divers)
Spouses
- male/female/diverse spouse of a cancer survivor
- FCR (FoP-Q-SF/P total score ≥ 34) or patients' FCR (FoP-Q-SF total score ≥ 34)
Patients and spouses:
- age ≥18 years
- fluency in the German language
- able to participate in the 6-week intervention (one session per week)
- written informed consent
Exclusion Criteria:
Patients:
- metastatic disease
Patients and spouses:
- both patient and spouse show low FCR (FoP-Q-SF total score < 34 or FoP-Q-SF/P total score < 34)
- individuals who previously (last 2 years) participated in an ACT-, CBT-, or mindfulness-based psychosocial intervention (psycho-oncological or psychotherapeutic interventions)
- severe psychiatric disorders and suicidality
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ACT-couple intervention for FCR
ACT couple intervention for FCR, including 4 couple sessions and 2 single sessions for patients and spouses + access to a digital intervention
|
The ACT couples intervention comprises six sessions, consisting of four couples' sessions and two individual sessions for cancer survivors and their partners.
The first and last sessions are held face-to-face and last 90 minutes.
For the other sessions, couples can choose between face-to-face sessions or video-based sessions via a video conferencing tool.
These sessions last 60 minutes.
All ACT flexibility skills are covered.
In addition, couples are given access to an online platform (CoupleACT).
Through this platform, participants receive ACT-specific audio files, homework assignments and written material to help them consolidate the content covered in the sessions.
|
|
有源比较器：CBT-couple intervention for FCR
CBT couple intervention for FCR, including four couple sessions and two single sessions for patients and spouses + access to a digital intervention
|
CBT: six sessions, comprising four couples' sessions and two individual sessions for cancer survivors and their partners.
The first and last sessions are held face-to-face and last 90 minutes.
For the other sessions, couples can choose between face-to-face sessions or video-based sessions via a video conferencing tool.
These sessions last 60 minutes.
The CBT couples intervention is based on an evaluated group therapy manual (Waadt et al., 2011).
It has been adapted for the couples' context and includes, amongst other things, behavioural analysis (SORK), psychoeducation, exposure, cognitive restructuring and mindfulness training.
In addition, couples are given access to an online platform (CoupleCare).
Through this platform, participants receive CBT-specific audio files, homework assignments and written material to reinforce the content covered in the
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fear of Progression Questionnaire (FoP-Q-SF) and partner version (FoP-Q-SF/P)
大体时间：From screening to three months follow up
|
We will assess FCR with the 12-item short form of the Fear of Progression Questionnaire (FoP-Q-SF), which is highly reliable and valid to assess FCR (68, 69). Also a validated partner version exists (FoP-Q-SF/P) which shows high reliability. (Primary outcome for preliminary efficacy). Response scale: 1-5, min. 12, max. 60. Higher scores = worse outcome (higher fear of progression); score ≥ 34 = clincial cut-off. |
From screening to three months follow up
|
|
feasibility outcomes: retention and recruiting rate
大体时间：screening to up to seven weeks (post-intervention)
|
screening to up to seven weeks (post-intervention)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Short-Form Health Survey (SF-12), Physical (PCS) and Mental (MCS) Component
大体时间：baseline to three-months follow-up
|
Health-related quality of life (HRQoL), 12 items; norm-based 0-100 scoring Min.
= 0, max = 100.
Higher scores = better outcome (better health-related quality of life)
|
baseline to three-months follow-up
|
|
Personal Health Questionnaire, depression module (PHQ-9)
大体时间：baseline to three-months follow-up
|
Assessment of depressive symptoms with 9 items, 4-point Likert scale (0-3), Min = 0; max = 27; higher scores = worse outcome (higher depression severity)
|
baseline to three-months follow-up
|
|
Generalized Anxiety Disorder scale (GAD-7)
大体时间：baseline to three-months follow-up
|
Assessment of anxiety symptoms with 7 items; 4-point Likert scale (0-3).
Min = 0; max = 21.
Higher scores = worse outcome (higher anxiety severity)
|
baseline to three-months follow-up
|
|
National Comprehensive Cancer Network (NCCN) Distress Thermometer
大体时间：baseline to three-months follow-up
|
Assessment of distress with a single item, visual analogue scale (0-10).
Min = 0; max = 10.
Higher scores = worse outcome (higher distress).
|
baseline to three-months follow-up
|
|
Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)
大体时间：baseline to three-months follow-up
|
Assessment of psychological flexibility with 8 items, 7-point Likert scale (0-6).
Min = 0; max = 48.
Higher scores = better outcome (higher psychological flexibility)
|
baseline to three-months follow-up
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cognitive Fusion Questionnaire (CFQ)
大体时间：baseline to three-months follow-up
|
Assessment of Cognitive fusion with 7 items, 7-point Likert scale (1-7).
Min.
= 7, max = 49.
Higher scores = worse outcome (higher cognitive fusion)
|
baseline to three-months follow-up
|
|
German version of the Peace, acceptance and equanimity in cancer experience (PEACE)
大体时间：baseline to three-months follow-up
|
Assessment of two subscales:
|
baseline to three-months follow-up
|
|
Valuing Questionnaire
大体时间：baseline to three-months follow-up
|
Assessment of valued living with two subscales:
|
baseline to three-months follow-up
|
|
Dyadic Coping Inventory (DCI)
大体时间：baseline to three-months follow-up
|
Dyadic coping with 35 items (of 37), 5-point Likert scale (1-5).
Min.
= 35; max.
= 175.
Higher scores = better outcome (better dyadic coping)
|
baseline to three-months follow-up
|
|
German version of the M.D. Anderson Symptom Inventory (MDASI-G)
大体时间：baseline to three-months follow-up
|
Assessment of two subscales:
|
baseline to three-months follow-up
|
|
Brief Fatigue Inventory (BFI)
大体时间：Baseline to three-months follow-up
|
Assessment of fatigue with 9 items (0-10), Min.
= 0, max = 90.
Higher scores = higher fatigue
|
Baseline to three-months follow-up
|
合作者和调查者
调查人员
- 首席研究员：Christina Sauer, PD Dr.、Frankfurt University Hospital
- 首席研究员：Gregor Weissflog, Dr.、Leipzig University Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.