Construction and Preliminary Evaluation of Dyadic Acceptance and Commitment Therapy for Couples With Fear of Lung Cancer Recurrence
15 de maio de 2026 atualizado por: Feifei Huang
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).
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
72
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Feifei Huang, Ph. D
- Número de telefone: +86 13763869099
- E-mail: pt860315@163.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Grupo de intervenção
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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. |
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Comparador Ativo: Grupo de controle
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① Health education:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in fear of cancer recurrence severity of lung cancer patients-The Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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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.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Change from baseline in fear of cancer recurrence severity of spouse caregivers-Fear of Cancer Recurrence Inventory Short Form-Caregiver Version (FCRI-SF-C)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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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.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recruitment Rate: Percentage of Eligible Participants Who Successfully Enroll in the Study Out of All Potentially Eligible Participants Meeting Inclusion/Exclusion Criteria
Prazo: Post-intervention (3 months)
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Recruitment rate is calculated as (number of eligible participants who successfully enroll in the study / total number of potentially eligible participants meeting all inclusion and none of the exclusion criteria) × 100%.
The rate ranges from 0% to 100%, with a higher rate indicating better recruitment efficiency.
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Post-intervention (3 months)
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Consent Compliance Rate: Percentage of Participants Who Sign Informed Consent Among Those Who Meet Inclusion Criteria
Prazo: Post-intervention (3 months)
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Consent compliance rate is calculated as (number of participants who sign the informed consent form / total number of participants who meet the predefined inclusion criteria) × 100%.
The rate ranges from 0% to 100%.
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Post-intervention (3 months)
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Participation Rate: Percentage of Randomized Participants Who Completed All Intervention Sessions
Prazo: Post-intervention (3 months)
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Participation rate is calculated as (number of participants who completed all intervention sessions / total number of participants randomized) × 100%.
The rate ranges from 0% to 100%.
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Post-intervention (3 months)
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Withdrawal Rate: Percentage of Initially Enrolled Participants Who Voluntarily Withdraw or Are Lost to Follow-Up
Prazo: Post-intervention (3 months)
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Withdrawal rate is calculated as (number of participants who voluntarily withdraw from the study or are lost to follow-up after enrollment / total number of participants initially enrolled) × 100%.
The rate ranges from 0% to 100%.
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Post-intervention (3 months)
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Number of Participants with Study-Related Adverse Events as Assessed by CTCAE v4.0
Prazo: Intervene in the whole process (3 months)
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The study uses a self-developed Adverse Event Form to document study-related adverse events (AEs) occurring during the study period.
The incidence rate is calculated as (number of participants experiencing at least one study-related AE / total number of enrolled participants) × 100%.
Severity grading follows the CTCAE v4.0.
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Intervene in the whole process (3 months)
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Satisfaction with the Intervention Program as Assessed by Qualitative Interviews
Prazo: Post-intervention (3 months)
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Semi-structured interviews are conducted by the investigator using a final interview guide developed through group brainstorming and revised by a nursing professor experienced in qualitative research.
Sampling continues until no new themes emerge and meaning saturation is achieved.
Thematic analysis is used to identify satisfaction-related patterns, and findings are reported with representative quotes.
No predefined numeric threshold is applied.
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Post-intervention (3 months)
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Change from baseline in fear of cancer recurrence triggering factors-The Fear of Cancer Recurrence Inventory-Triggering factors (FCRI-T)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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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.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Change from baseline in psychological flexibility-Comprehensive Assessment of ACT Processes (CompACT)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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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.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Change from baseline in illness perception-Brief Illness Perception Questionnaire (B-IPQ)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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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.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Change from baseline in dyadic coping-Dyadic Coping Inventory (DCI)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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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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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Change from baseline in intimate relationship-Unidimensional Relationship Closeness Scale (URCS)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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This 11-item scale uses a 5-point scale from 1 to 5. 1 is equivalent to "strongly disagree" and 5 indicates "strongly agree".
The mean of all item scores is calculated, ranging from 1 to 5, where 1 indicates the lowest perceived closeness and 5 indicates the highest perceived closeness.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Change from baseline in family care-Family Adaptation, Partnership, Growth, Affection, Resolve index Questionnaire (Family APGAR Questionnaire)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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The Family APGAR has 5 items, each scored from 0 to 2. Zero is equivalent to "hardly ever" and 2 indicates "almost always".
Total scores range from 0 to 10, where 0 indicates the poorest family function and 10 indicates the best family function.
Scores of 7-10 indicate good family function, 4-6 moderate dysfunction, and 0-3 severe dysfunction.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Change from baseline in quality of life of lung cancer patients-Functional Assessment of Cancer Therapy (FACT-L V4.0)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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The FACT-L V4.0 consists of 36 items.
Each item is scored from 0 to 4. Zero is equivalent to "not at all" and 4 indicates "very much".
Positively worded items are scored 0-4; reverse-worded items are scored 4-0.
The total score is the sum of five dimension scores (physical, social/family, emotional, functional, and lung-specific), ranging from 0 to 144, where 0 indicates the poorest possible quality of life and 144 indicates the best possible quality of life.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Change from baseline in quality of life of spouse caregivers-The 12-item short from healthy survey (SF-12)
Prazo: Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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The SF-12 includes 12 items covering eight dimensions.
Items 1,8,9,10 are reverse-scored.
Standardized scores for the PCS and MCS each range from 0 to 100, where 0 indicates the worst possible quality of life and 100 indicates the best possible quality of life.
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Baseline, after the third intervention (1.5 months), post-intervention (3 months), 1 month after intervention (4 months)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Feifei Huang, Ph. D, Fujian Medical University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de maio de 2026
Conclusão Primária (Estimado)
30 de junho de 2027
Conclusão do estudo (Estimado)
30 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
4 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de maio de 2026
Primeira postagem (Real)
14 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Ethical Review No. 2 (2026)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
The datasets are not publicly available due privacy reasons but are available from the director upon reasonable request.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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