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

NCT07588347 | Not Yet Recruiting

• 1 other identifier: Ethical Review No. 2 (2026)
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Lung Neoplasms; Spouses; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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.

  Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)

Secondary Outcomes (14)

• Change from baseline in fear of cancer recurrence triggering factors-The Fear of Cancer Recurrence Inventory-Triggering factors (FCRI-T)

  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)

  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)

  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)

  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)

  Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)

Study Arms (2)

Control group

ACTIVE COMPARATOR

Other: routine care

Intervention group

EXPERIMENTAL

Other: Dyadic Acceptance and Commitment Therapy (ACT) for lung cancer patients and their spouse caregivers addressing FCR and routine care

Interventions

routine care OTHER

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 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.

Control group

Dyadic Acceptance and Commitment Therapy (ACT) for lung cancer patients and their spouse caregivers addressing FCR and routine care OTHER

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 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.

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Feifei Huang: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Feifei Huang, Ph. D

  Fujian Medical University

  STUDY DIRECTOR

Central Study Contacts

Feifei Huang, Ph. D

CONTACT

+86 13763869099; pt860315@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 14, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share