About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Dyadic Acceptance and Commitment Therapy (ACT) for lung cancer patients and their spouse caregivers addressing FCR and routine care
- routine care
Treatment groups
Locations
Sponsors and collaborators
Feifei Huang
Lead sponsor
Fujian Medical University
Sponsor institution