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

Overview

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).

Interventions

• Other 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
• Other 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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗