Construction and Preliminary Evaluation of Dyadic Acceptance and Commitment Therapy for Couples With Fear of Lung Cancer Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Change from baseline in fear of cancer recurrence severity of lung cancer patients-The Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
研究概览
简要总结
The goal of this clinical trial is to develop a simple, scientific, effective, and culturally adapted dyadic Acceptance and Commitment Therapy (ACT) intervention program (the ADAPT program) targeting fear of cancer recurrence (FCR) among lung cancer patients and their spouse caregivers. The study will also evaluate the feasibility, acceptability, and preliminary effectiveness of the ADAPT program.
The main research questions are as follows:
- Is the ADAPT intervention program feasible and acceptable for lung cancer patients and their spouse caregivers?
- Compared with usual care, can the ADAPT intervention program preliminarily reduce FCR levels in both patients and their spouse caregivers? Can the program improve coping styles, illness perceptions, family functioning, and intimate relationships among both patients and their spouse caregivers? Can the program enhance psychological flexibility and quality of life (QOL) in both patients and their spouse caregivers? Researchers will compare the ADAPT intervention program with usual care to evaluate its preliminary effectiveness in reducing FCR among lung cancer patients and their spouse caregivers.
Participants will:
- Receive the ADAPT intervention twice during each radiotherapy and/or chemotherapy cycle, for a total of three treatment cycles (approximately 3 months);
- Complete questionnaires at baseline (before the intervention), immediately after the intervention, and one month post-intervention;
- Report outcomes including FCR severity, FCR triggers, psychological flexibility, illness perception, dyadic coping, family functioning, intimacy, and quality of life (QOL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary lung cancer confirmed by pathological examination.
- •Age ≥ 22 years for men and ≥ 20 years for women (legal marriage age in China).
- •Have undergone lung cancer surgery and are scheduled to receive the first round of radiotherapy and/or chemotherapy treatment
- •Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score ≥ 13, indicating moderate-to-severe FCR.
- •Eastern Cooperative Oncology Group (ECOG) ≤
- •Aware of their diagnosis and willing to participate voluntarily.
- •Normal cognitive function (Montreal Cognitive Assessment [MoCA] score ≥ 26), alert and conscious, and able and willing to communicate their thoughts.
- •Spouse Caregivers:
- •Identified by the patient as the primary caregiver, providing ≥ 50% of care in the past 2 weeks.
- •Legally married to the patient.
- •Age ≥ 22 years for men and ≥ 20 years for women.
- •Normal cognitive function (MoCA score ≥ 26), no diagnosed mental disorders, able to communicate effectively, and willing to share their thoughts.
排除标准
- •Diagnosed mental disorders or currently receiving psychiatric treatment.
- •Presence of personality disorders, intellectual disability, memory disorders, brain injury, or neurological disease.
- •Concurrent malignant tumors in other organs.
- •Severe complications (e.g., chest pain and/or dyspnea due to pleural tumor invasion).
- •Spouse caregiver unwilling to participate.
- •History of upper limb fractures or surgery resulting in impaired hand function.
- •Participation in other similar psychological interventions.
- •Spouse Caregivers:
- •Presence of serious comorbid conditions (e.g., respiratory failure, malignant tumors, or other critical illnesses).
- •Patient unwilling to participate.
- •Participation in other research studies.
研究组 & 干预措施
Control group
干预措施: routine care (Other)
Intervention group
干预措施: Dyadic Acceptance and Commitment Therapy (ACT) for lung cancer patients and their spouse caregivers addressing FCR and routine care (Other)
结局指标
主要结局
Change from baseline in fear of cancer recurrence severity of lung cancer patients-The Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
时间窗: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
The scale consists of 9 items, each rated from 0 to 4. Zero is equivalent to "never" and 4 indicates "always". Total scores range from 0 to 36, where 0 indicates no fear of cancer recurrence and 36 indicates the highest possible fear. A score of 13 or higher is defined as subclinical fear of cancer recurrence.
Change from baseline in fear of cancer recurrence severity of spouse caregivers-Fear of Cancer Recurrence Inventory Short Form-Caregiver Version (FCRI-SF-C)
时间窗: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
The scale consists of 9 items, each rated from 0 to 4. Zero is equivalent to "never" and 4 indicates "always". Total scores range from 0 to 36, where 0 indicates no fear of cancer recurrence and 36 indicates the highest possible fear. A score of 13 or higher is defined as subclinical fear of cancer recurrence.
次要结局
- Change from baseline in fear of cancer recurrence triggering factors-The Fear of Cancer Recurrence Inventory-Triggering factors (FCRI-T)(Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months))
- Change from baseline in psychological flexibility-Comprehensive Assessment of ACT Processes (CompACT)(Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months))
- Change from baseline in illness perception-Brief Illness Perception Questionnaire (B-IPQ)(Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months))
- Change from baseline in dyadic coping-Dyadic Coping Inventory (DCI)(Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months))
- Change from baseline in intimate relationship-Unidimensional Relationship Closeness Scale (URCS)(Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months))
- Change from baseline in family care-Family Adaptation, Partnership, Growth, Affection, Resolve index Questionnaire (Family APGAR Questionnaire)(Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months))
- Change from baseline in quality of life of lung cancer patients-Functional Assessment of Cancer Therapy (FACT-L V4.0)(Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months))
- Change from baseline in quality of life of spouse caregivers-The 12-item short from healthy survey (SF-12)(Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months))
- Recruitment Rate: Percentage of Eligible Participants Who Successfully Enroll in the Study Out of All Potentially Eligible Participants Meeting Inclusion/Exclusion Criteria(Post-intervention (3 months))
- Consent Compliance Rate: Percentage of Participants Who Sign Informed Consent Among Those Who Meet Inclusion Criteria(Post-intervention (3 months))
- Participation Rate: Percentage of Randomized Participants Who Completed All Intervention Sessions(Post-intervention (3 months))
- Withdrawal Rate: Percentage of Initially Enrolled Participants Who Voluntarily Withdraw or Are Lost to Follow-Up(Post-intervention (3 months))
- Number of Participants with Study-Related Adverse Events as Assessed by CTCAE v4.0(Intervene in the whole process (3 months))
- Satisfaction with the Intervention Program as Assessed by Qualitative Interviews(Post-intervention (3 months))
研究者
Feifei Huang
Professor
Fujian Medical University