Conquer Fear SUPPORT: A Psychosocial Intervention in Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking enrollment rate.
研究概览
简要总结
This trial will pilot a psychosocial intervention called Conquer Fear Support (CFS) in patients with stage III-IV lung or gynecologic cancer who are experiencing fear of cancer progression. The intervention is adapted from a novel program called "Conquer Fear" which was developed by researchers in Australia. CFS may help in reducing worries, fears, and uncertainty in patients with advanced lung or gynecological cancer.
详细描述
PRIMARY OBJECTIVES:
I. Assess the feasibility and acceptability of the CFS intervention in patients with advanced lung and gynecologic (GYN) cancer (stages III or IV) who have clinically significant levels of fear of cancer progression (FOP) or cancer-related distress.
SECONDARY OBJECTIVES:
I. Assess preliminary effects of the intervention on FOP, cancer-specific distress, anxiety, depression, overall symptom distress, metacognitions, and mindfulness.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gynecologic (GYN) and lung cancer will be recruited
- •Stage III or IV disease
- •At least 3 months from initial diagnosis
- •Receiving disease-focused treatment or active surveillance mode
- •A score of ≥ 34 on the Fear of Progression Questionnaire-Short Form (SF) or ≥ 24 on the Impact of Event Scale-Revised
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
排除标准
- •Current severe depression or psychosis; significant cognitive impairment
- •Patients enrolled in hospice care or who opt to receive no further disease-focused treatment
- •Patients who are currently receiving ongoing psychiatric treatment
- •Non-English speaking
研究组 & 干预措施
Supportive care (CFS)
Patients attend CFS psychosocial intervention consisting of 7 nurse-led sessions (session 1 in-person and sessions 2-7 via video conferencing) over 45 minutes each for 8 weeks. Patients also complete home practice assignments comprising attention training technique and mindfulness practice after each session.
Patients complete self-report questionnaires at baseline (T1), 8 weeks (T2) and 12 weeks (T3).
干预措施: Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components) (Behavioral)
Supportive care (CFS)
Patients attend CFS psychosocial intervention consisting of 7 nurse-led sessions (session 1 in-person and sessions 2-7 via video conferencing) over 45 minutes each for 8 weeks. Patients also complete home practice assignments comprising attention training technique and mindfulness practice after each session.
Patients complete self-report questionnaires at baseline (T1), 8 weeks (T2) and 12 weeks (T3).
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking enrollment rate.
时间窗: Up to 9 months
Evaluate the enrollment (recruitment) rate over the study period. Feasibility will be deemed acceptable if at least 25 eligible participants are accrued within 9 months.
Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attrition.
时间窗: Up to week 12
Evaluate attrition (drop-out rate) over time for enrolled participants. Feasibility will be deemed acceptable if the percentage of patients who drop-out does not exceed 20% by week 8 of the intervention and 50% by week 12 of the intervention.
Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attendance.
时间窗: Up to week 12
Evaluate the percentage of sessions attended. Feasibility will be deemed acceptable if participants attend an average of 5 of the 7 scheduled sessions.
Number of Eligible Participants
时间窗: Up to 9 months
Enrollment rate will be deemed sufficient if at least 33 eligible patients are accrued within 9 months.
Attrition
时间窗: Up to Week 12
Feasibility of the Conquer Fear SUPPORT (CFS) intervention will be assessed by tracking attrition. Attrition is defined as the percentage of participants who withdraw from the study among enrolled participants who completed the baseline questionnaire (i.e., evaluable participants). Feasibility will be evaluated based on whether attrition remains within the prespecified study thresholds at Week 8 (T2) and Week 12 (T3).
Number of Sessions Attended
时间窗: Up to 12 weeks
Attendance was assessed as the number of intervention sessions attended by each participant. Seven intervention sessions were offered during the study period.
Percentage of Participants Who Reported Home Practice
时间窗: Up to 12 weeks
Home practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported engaging in assigned home practice activities.
Percentage of Participants Who Completed All Assigned Home Practice
时间窗: Up to 12 weeks
Completion of assigned home practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported completing all assigned home practice activities.
Percentage of Participants Who Reported Attention Training Practice for at Least One Week
时间窗: Up to 12 weeks
Attention training practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported engaging in attention training practice for at least one week.
次要结局
- Fear of progression (FOP) assessed using Fear of Progression Questionnaire-Short Form (SF)(Up to week 12)
- Overall symptom distress assessed using the Memorial Symptom Assessment Scale (MSAS)(Up to week 12)
- Cancer-specific distress assessed using the Impact of Event Scale-Revised (IES-R)(Up to week 12)
- Anxiety assessed using the PROMIS-Anxiety 8a(Up to week 12)
- Metacognitions (MCQ-30) assessed using the Metacognitions Questionnaire(Up to week 12)
- Depression assessed using the Patient Health Questionnaire (PHQ-9)(Up to week 12)
- Mindfulness assessed using the Five Facet Mindfulness Questionnaire (FFMQ-15)(Up to week 12)
- Fear of Progression(T1 (Baseline), T2 (Week 8), and T3 (Week 12))
- Cancer-specific Distress(T1 (Baseline), T2 (Week 8), and T3 (Week 12))
- Anxiety(T1 (Baseline), T2 (Week 8), and T3 (Week 12))
- Depression(T1 (Baseline), T2 (Week 8), and T3 (Week 12))
- Overall Symptom Distress(T1 (Baseline), T2 (Week 8), and T3 (Week 12))
- Metacognitions(T1 (Baseline), T2 (Week 8), and T3 (Week 12))
- Mindfulness(T1 (Baseline), T2 (Week 8), and T3 (Week 12))