Construction and Preliminary Evaluation of Dyadic Acceptance and Commitment Therapy for Couples With Fear of Lung Cancer Recurrence

Обзор

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).

Вмешательства

• Другое Dyadic Acceptance and Commitment Therapy (ACT) for lung cancer patients and their spouse caregivers addressing FCR and routine care
  In addition to routine care provided to the control group, the ACT intervention will be delivered by researchers who have completed formal training in Acceptance and Commitment Therapy (ACT). The intervention will be conducted in a quiet and comfortable demonstration room within the department. The intervention will be delivered in a face-to-face, couple-based format. It will consist of six sessions, with two sessions per treatment cycle, each lasting 35-75 minutes, over a total of three treatm
• Другое routine care
  ① Health education: 1. Disease knowledge education 2. Nutrition and hygiene education * Follow-up management and symptom monitoring: Conduct a telephone follow-up within one month after the patient is discharged from the hospital to ensure timely monitoring of the patient's physical condition. * Home rehabilitation management: Provide nutritional counseling services for the patient and spouse caregiver, guide home-based dietary adjustments, and maintain good nutritional status and imm

Первичные конечные точки

• Change from baseline in fear of cancer recurrence severity of lung cancer patients-The Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) [Срок оценки: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)]
• Change from baseline in fear of cancer recurrence severity of spouse caregivers-Fear of Cancer Recurrence Inventory Short Form-Caregiver Version (FCRI-SF-C) [Срок оценки: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)]

Вторичные конечные точки (12)

• Change from baseline in fear of cancer recurrence triggering factors-The Fear of Cancer Recurrence Inventory-Triggering factors (FCRI-T) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Post-intervention (3 months)]
• Consent Compliance Rate: Percentage of Participants Who Sign Informed Consent Among Those Who Meet Inclusion Criteria [Срок оценки: Post-intervention (3 months)]
• Participation Rate: Percentage of Randomized Participants Who Completed All Intervention Sessions [Срок оценки: Post-intervention (3 months)]
• Withdrawal Rate: Percentage of Initially Enrolled Participants Who Voluntarily Withdraw or Are Lost to Follow-Up [Срок оценки: Post-intervention (3 months)]

Критерии участия

Критерии включения

Patients:

• 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) ≤2.
• 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.

Критерии исключения

Patients:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07588347 · Ethical Review No. 2 (2026)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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