Development and Pilot Trial of Focused ACT (FACT) for Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Safety and Adverse Events (AEs)
研究概览
简要总结
To learn about the effects of an intervention program called Focused Acceptance and Commitment Therapy (FACT) on the level of anxiety patients diagnosed with cancer feel about death.
To learn if an intervention program called Focused Acceptance and Commitment Therapy (FACT), designed to help reduce death-related anxiety, is effective and acceptable to patients diagnosed with advanced cancer.
详细描述
Primary Objectives:
Phase 1 To estimate the initial feasibility and acceptability of delivering the iteratively developed FACT in a single-arm pilot trial. We hypothesize that FACT will be both feasible (defined criteria: ≥90% on intervention fidelity ratings, attendance of ≥70% of FACT sessions, retention post-intervention assessment completion 70%) and acceptable (defined criteria: patients will report average satisfaction as ≥4/5; average appropriateness of the intervention as ≥4/5; ≥75% would recommend FACT to others, and ≥50% indicate they are likely to use FACT strategies following sessions).
Phase 2 To estimate initial within person change in self-report measures of death anxiety (DADDS) and cognitive fusion (CFQ) from baseline to post-treatment and 6-week follow-up assessment, in patients who participate in FACT intervention.
Secondary Objectives:
Phase 1 To estimate initial within person change in self-report measures of death anxiety (DADDS), death anxiety 2 item measure, cognitive fusion (CFQ), QOL (QUAL-E), anxiety (GAD-7), depression (CES-D), perceived stress (PSS), perceived social support (ISEL), illness understanding (Prigerson Illness Understanding Scale) and coping strategies (Brief COPE)) from baseline to post-treatment and 6-week follow-up assessment in patients who participate in FACT intervention in a single-arm pilot trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult cancer patients diagnosed with advanced cancer (solid tumor and hematologic)
- •Progressed past at least one line of palliative systemic cancer therapy
- •Patient followed by Supportive Care Outpatient Service
- •English speaking
- •Able to provide written informed consent
- •Willing to participate in a stress and coping program
- •Willing to identify 1-2 important areas of life they might like to discuss with a counselor
- •Moderate levels of death anxiety on DADDS (>=25, on 0-75 scale)
- •Access to technology to support institutionally approved video-conferencing platform of Zoom
排除标准
- •ECOG performance status >=3 "capable of only limited selfcare; confined to bed or chair more than 50% of waking hours"
- •Currently participating in regular psychotherapy (patient defined)
- •Documented out of hospital DNR (do not resuscitate) orders
- •Presence of active suicidal ideation or need for a higher level of care (as determined by Supportive Care physician or licensed mental health clinician).
研究组 & 干预措施
Examine Initial Acceptability and Efficacy Signal of FACT
Potential participants will be identified weekly via MDACC's computerized appointment system for the Supportive Care Outpatient Clinic.
干预措施: FACT Session (Behavioral)
Controlled Trial (RCT) to Examine Feasibility, Acceptability and Initially Efficacy of FACT
Potential participants will be identified weekly via MDACC's computerized appointment system for the Supportive Care Outpatient Clinic.
干预措施: Enhanced Usual Care and Assessments (Behavioral)
结局指标
主要结局
1. Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点