Clinical trial · Interventional
Construction and Preliminary Evaluation of Dyadic Acceptance and Commitment Therapy for Couples With Fear of Lung Cancer Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acceptance and Commitment Therapy | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Spouses | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dyadic Acceptance and Commitment Therapy (ACT) for lung cancer patients and their spouse caregivers addressing FCR and routine care | Other | — | UNRESOLVED |
| routine care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- interventionNames
- Other: routine care
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Other: Dyadic Acceptance and Commitment Therapy (ACT) for lung cancer patients and their spouse caregivers addressing FCR and routine care
Primary outcomes (2)
- measure
- Change from baseline in fear of cancer recurrence severity of lung cancer patients-The Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
- timeFrame
- Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available