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).
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.
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).
Parallel
Dyadic Acceptance and Commitment Therapy (ACT) for lung cancer patients and their spouse caregivers addressing FCR and routine care
Other interventionIn 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 treatment cycles. The intervention will incorporate techniques such as metaphor-based exercises, mindful breathing, body scan, the T-puzzle, and the Chinese finger trap. The preliminary structure is as follows: six fixed in-person sessions (Sessions 1-6), supplemented by online homework assignments completed between sessions.
routine care
Other intervention① 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 immunity. Encourage the patient and spouse caregiver to communicate promptly with the medical team when experiencing uncomfortable symptoms, thereby speeding up recovery and improving rehabilitation outcomes.
Change from baseline in fear of cancer recurrence severity of lung cancer patients-The Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
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)
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 triggering factors-The Fear of Cancer Recurrence Inventory-Triggering factors (FCRI-T)
This 8-item dimension assesses how often daily triggers elicit fear of cancer recurrence. Each item is scored from 0 to 4. Zero is equivalent to "never" and 4 indicates "always". Total scores range from 0 to 32, where 0 indicates that none of the factors trigger fear and 32 indicates that all factors always trigger fear.
Change from baseline in psychological flexibility-Comprehensive Assessment of ACT Processes (CompACT)
The CompACT contains 22 items, each scored from 0 to 6. Zero is equivalent to "never" and 6 indicates "always". After reverse-scoring the values and committed action domain (plus four items of the mindfulness and self-as-context domain), total scores range from 0 to 132, where 0 indicates the lowest possible psychological flexibility and 132 indicates the highest possible psychological flexibility.
Change from baseline in illness perception-Brief Illness Perception Questionnaire (B-IPQ)
The B-IPQ includes 8 items, each scored from 0 to 10. Zero is equivalent to "no perception of that aspect" and 10 indicates "extreme perception of that aspect". Total scores range from 0 to 80, where 0 indicates a very benign illness perception and 80 indicates the most threatening illness perception possible. The ninth open-ended item asks participants to list the three most important causal factors.
Change from baseline in dyadic coping-Dyadic Coping Inventory (DCI)
The DCI consists of 37 items, each rated from 1 to 5. One is equivalent to "very rarely" and 5 indicates "very frequently". Total scores range from 35 to 75, where 35 indicates the lowest possible dyadic coping competence and 75 indicates the highest possible dyadic coping competence.
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Feifei Huang
Lead sponsor
Fujian Medical University
Sponsor institution
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