Online Psychosocial Intervention for Women With Lung Cancer Undergoing Treatment
概览
- 阶段
- 不适用
- 干预措施
- Behavioral Intervention
- 疾病 / 适应症
- Non-Small Cell Lung Carcinoma
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- BREATHE intervention in women with Lung Cancer determined successful by acceptability
- 状态
- 进行中（未招募）
- 最后更新
- 17天前
概览
简要总结
This trial studies how well online psychosocial intervention works in improving social well-being and support in women who are undergoing treatment for stage I-IV non-small cell lung cancer. Psychosocial intervention techniques, such as mindfulness, compassion, and emotional processing, may improve distress and help patients manage symptoms related to non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES: I. Examine the feasibility (primary outcome) of the BREATHE intervention in women with lung cancer (LC). SECONDARY OBJECTIVES: I. Establish the initial intervention efficacy regarding psychological distress (secondary outcome) and cancer symptoms (tertiary outcome) relative to an education comparison (EC) group. EXPLORATORY OBJECTIVES: I. Explore potential mediation (e.g., mindfulness, compassion, inflammatory processes) and moderation (e.g., demographic and medical factors) of the intervention effects. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (PSYCHOLOGICAL): Patients participate in 5 psychological sessions and complete training on mindfulness, compassion, emotional processing, social support, generating positive emotions, and proactive coping strategies once a week for up to 5 weeks. Patients also complete questionnaires over 35 minutes and participate in video-based group sessions weekly for 5 weeks. GROUP II (EDUCATIONAL): Patients participate in 5 information sessions and receive education on lung cancer, symptom management, communication, and practicing self-care once a week for up to 5 weeks. Patients also complete questionnaires and participate in group sessions as in group I. After completion of study intervention, patients are followed up at 1 week and at 3 months.
研究者
入排标准
入选标准
- •Women diagnosed with stage I-IV non-small cell lung cancer within 3 months of diagnosis at the time of recruitment and receiving any type of treatment at the time of recruitment. For women with metastatic disease, disease must be stable (without disease progression based on patients' latest imaging impressions) per treating oncologist
- •Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- •Have access to the internet
- •Able to read, write and speak English
排除标准
- •Major psychiatric or cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
- •Regular (self-defined) participation in psychotherapy or a formal cancer support group
研究组 & 干预措施
Group I (psychological intervention)
Patients participate in 5 psychological sessions and complete training on mindfulness, compassion, emotional processing, social support, generating positive emotions, and proactive coping strategies once a week for up to 5 weeks. Patients also complete questionnaires over 35 minutes and participate in video-based group sessions weekly for 5 weeks.
干预措施: Behavioral Intervention
Group I (psychological intervention)
Patients participate in 5 psychological sessions and complete training on mindfulness, compassion, emotional processing, social support, generating positive emotions, and proactive coping strategies once a week for up to 5 weeks. Patients also complete questionnaires over 35 minutes and participate in video-based group sessions weekly for 5 weeks.
干预措施: Questionnaire Administration
Group I (psychological intervention)
Patients participate in 5 psychological sessions and complete training on mindfulness, compassion, emotional processing, social support, generating positive emotions, and proactive coping strategies once a week for up to 5 weeks. Patients also complete questionnaires over 35 minutes and participate in video-based group sessions weekly for 5 weeks.
干预措施: Support Group Therapy
Group II (educational intervention)
Patients participate in 5 information sessions and receive education on lung cancer, symptom management, communication, and practicing self-care once a week for up to 5 weeks. Patients also complete questionnaires and participate in group sessions as in group I.
干预措施: Educational Intervention
Group II (educational intervention)
Patients participate in 5 information sessions and receive education on lung cancer, symptom management, communication, and practicing self-care once a week for up to 5 weeks. Patients also complete questionnaires and participate in group sessions as in group I.
干预措施: Questionnaire Administration
Group II (educational intervention)
Patients participate in 5 information sessions and receive education on lung cancer, symptom management, communication, and practicing self-care once a week for up to 5 weeks. Patients also complete questionnaires and participate in group sessions as in group I.
干预措施: Support Group Therapy
结局指标
主要结局
BREATHE intervention in women with Lung Cancer determined successful by acceptability
时间窗: Up to 3 months
Acceptability assessed by ≥ 75% of participants indicating that the program is useful and enjoyable in each arm.
BREATHE intervention in women with Lung Cancer determined successful by overall accrual
时间窗: Up to 3 months
Overall accrual assessed by ≥ 50% of eligible patients consent (i.e., approach 140 to achieve 70 that consent).
BREATHE intervention in women with Lung Cancer determined successful by attrition
时间窗: Up to 3 months
Attrition assessed by ≥ 71% of enrolled patients (≥ 50 patients) complete T1 and T2 assessments;
BREATHE intervention in women with Lung Cancer determined successful by adherence
时间窗: Up to 3 months
Adherence assessed by ≥ 75% of all practice sessions are attended in each arm.
次要结局
- Efficacy regarding psychological distress: CES-D(Up to 3 months)
- Efficacy regarding cancer symptoms: IES(Up to 3 months)