Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Change in Fear of Cancer Recurrence from Baseline
研究概览
简要总结
Fear of cancer recurrence (FCR) is a highly prevalent, disruptive, and under-treated problem for breast cancer survivors. This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors suffering from FCR while examining its cost-effectiveness and the mechanisms by which the intervention may work. Study findings will guide the future care of breast cancer survivors with FCR.
详细描述
The primary objective of this 3-arm randomized control trial (RCT) is to build on the investigators' pilot work by testing the impact of Acceptance Commitment Therapy (ACT) on FCR. The investigators will randomly assign up to 375 early-stage Breast Cancer Survivors (BCS; for at least 300 study completers after attrition) who have finished primary cancer treatment and who report clinically significant FCR to: (1) group-based ACT (6 weekly 1.5-hour videoconference sessions), (2) group-based Cognitive Behavioral Therapy (CBT; 6 weekly 1.5-hour videoconference sessions), or (3) Enhanced Usual Care (EUC; a single 90-minute videoconference coaching session with self-administered readings). Outcomes will be assessed at baseline and at 2, 6, and 12 months; additionally, potential theory-driven mediators of the ACT intervention's effects on key outcomes will be analyzed at these time points and at intervention midpoint. Cost-effectiveness of each intervention will be assessed.
Specific Aims are to: (1) test the efficacy of group-based ACT compared to CBT and EUC on FCR (primary outcome) and anxiety, depressive symptoms, post-traumatic stress, avoidant coping, fatigue, sleep disturbance, and quality of life (secondary outcomes) in BCS with clinical FCR; (2) to examine changes in psychological flexibility as a mediator of ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
An external statistician will create the randomization sequence. An unblinded research manager will maintain the randomization sequence and randomization assignment for each participant in password-protected databases not accessible by the study team. All study personnel, including the study's principal investigator (PI), biostatistician, data manager, research coordinator (RC), and research assistants (RAs), will be blind to the randomization sequence. The PI, research manager, interventionists, and intervention supervisors will be the only individuals privy to participants' randomization assignments. The study RC, RAs (including outcome assessors), and the study biostatistician and data manager will remain blind to participants' random assignments for the trial's duration to enhance rigor and reduce the risk of outcome expectancy and other biases. Participants will be blind to study hypotheses, yet will be aware of their assignment to a 6-session versus single-session intervention.
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
- •Patient is ≥18 years old.
- •Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
- •Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≤5 years prior (ongoing endocrine therapy is allowed).
- •Patient has clinically significant FCR (FCR-7 score ≥17 at screening).
- •Patient is willing to be randomized into any of the 3 arms of the trial and attend a 6-week videoconference group if randomly assigned to ACT or CBT and a single videoconference group if randomly assigned to EUC.
- •Patient is able to speak and read English
排除标准
- •Patient has a previous cancer diagnosis besides breast (non-melanoma skin cancer or melanoma in situ is allowed).
- •Patient is currently participating in ACT, CBT, formal mindfulness meditation training, the "Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial," the "Thinking and Living With Cancer" study, or any other research study that has the potential to skew results of this study or the study in which the person is participating.
- •Patient has co-morbidities, medications, or deficits that would impair participation in any of the 3 groups (ACT, CBT or EUC), including: history of stroke, encephalitis, traumatic brain injury/surgery, Alzheimer's disease, or other dementia; severe depressive symptoms (PHQ-2 score ≥5 at screening); active substance abuse or uncontrolled bipolar disorder, psychosis, or schizophrenia; obvious hearing and/or communicative disability.
- •Patient has opted out of pre-screening for research studies (sometimes noted in the electronic medical record)
结局指标
主要结局
Change in Fear of Cancer Recurrence from Baseline
时间窗: given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
The 43-item Fear of Cancer Recurrence Inventory (FCRI) includes triggers, psychological distress, coping strategies, reassurance seeking, insight, severity, and functional impairments subscales. Each item is rated on a scale from 0 (never, not at all, or I don't think about it) to 4 (all the time or a great deal), participants indicate the extent to which they are fearful, with higher scores indicating greater FCR.
次要结局
- Change in Fear of Cancer Recurrence Questionnaire - 7 (FCR-7) from Baseline(Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Anxiety Symptoms from Baseline(Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Quality of Life from Baseline(Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Fear of Cancer Recurrence Global Anchor(Given at 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Depression from Baseline(Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Anxiety from Baseline(Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Sleep Disturbance from Baseline(Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Concerns about Recurrence (CARS) from Baseline(Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Depressive Symptoms from Baseline(Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Coping from Baseline(Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Post-Traumatic Stress Symptoms from Baseline(Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
- Change in Fatigue from Baseline(Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4))
研究者
Shelley Johns
Associate Professor of Medicine, Research Scientist
Indiana University