Clinical trial · Interventional
Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients
- 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 majority of cancer patients experience varying degrees of psychological distress and physical symptoms due to the presence of cancer or the process of treatment. These symptoms are closely associated with inflammatory markers and patient prognosis, highlighting the urgent need for effective psychological intervention methods. Behavioral activation, an emerging psychological intervention approach, requires further investigation regarding its potential in alleviating negative emotions among cancer patients. Therefore, the objective of this study is to investigate whether (1) behavioral activation can ameliorate negative emotions and physical symptoms in cancer patients; (2) behavioral activation can contribute to improved survival outcomes for these patients; and (3) behavioral activation can enhance NLR levels and other clinical indicators among individuals with cancer. The investigators aimed to recruit esophageal and gastric cancer, colorectal cancer, and non-small cell lung cancer (NSCLC) patients. These patients were recruited from the Department of Oncology at the Second Affiliated Hospital of Anhui Medical University between March 2023 and November 2023. They are divided into seven cohorts. Cohorts 1-5 are randomized control trials and within each cohort, patients were randomly allocated into two groups: an intervention group (behavioral activation+care as usual, BA+CAU) and a control group (care as usual, CAU). The intervention group underwent an eight-week behavioral activation program (see Detailed Description) designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles. Both the intervention group and the control group received standard care along with conventional treatment for their respective cancers. Cohorts 6-7 are prospective cohort studies, in addition to the aforementioned groups, and include an additional control group. Detailed information for each cohort is provided in Detailed Description. This study aims to demonstrate the significant efficacy of behavioral activation in improving negative emotions, somatic symptoms, quality of life, and clinical inflammatory indicators among cancer patients. Furthermore, it may potentially enhance patient survival rates, thereby offering a novel approach for psychological intervention in cancer patients and contributing to multidisciplinary treatment and management strategies. The intervention measures employed in this study do not involve any pharmacological treatments or hazardous activities. For illiterate or less educated patients, the informed consent process and questionnaire collection will be conducted using methods that ensure their full comprehension (e.g., verbal explanations, visual aids). Additionally, patients with evident cognitive impairments were excluded from the study. The investigators have implemented a questionnaire system on the WJX website (https://www.wjx.cn/) to collect patient information through both paper and electronic questionnaires. The psychological measurement questionnaires are stored electronically, while socio-demographic data and clinical indicators are collected in the hospital's medical record management system. Subsequently, all data is summarized and saved in local Excel files and SPSS files for specialized analysis by data analysts. Patient names are anonymized within the database, ensuring strict confidentiality of personal information such as contact details and home address. Possible statistical methods include descriptive statistical analysis, generalized estimating equation or repeated measures analysis of variance, structural equation modeling, correlation analysis and regression, survival analysis, etc.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral activation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Behavioral activation + Care as usual
- description
- Cohort 1-5: Intervention Group
- interventionNames
- Behavioral: behavioral activation
- type
- NO_INTERVENTION
- label
- Care as usual
- description
- Cohort 1-5: Control Group
Primary outcomes (38)
- measure
- Sociodemographic data
- timeFrame
- Day 0
- description
- The sociodemographic data includes gender, age, smoking, drinking, working, marital status, and education level. This information is extracted from the medical record.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Cohort 1: Inclusion criteria: (Patients who) * Had to meet the diagnostic criteria for esophageal or gastric cancer through clinical, pathological, and imaging examinations, * Should have no history of prior psychological intervention, * Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points, * Were required to complete the questionnaire independently or with assistance from others if needed, * Were consistently admitted to the hospital for tumor treatment, with an average time interval of approximately one month between each hospitalization, * Were reporting stigma and its possible causes, the average score of the Social Impact Scale exceeded 1, * Were of legal age, 18 years or older. Exclusion criteria: (Patients who) * With severe intellectual disabilities or other communication difficulties that hindered normal interaction, * With an expected survival time of less than 4 months, * Were Cachexia or severely debilitated, * With fractures, serious heart dysfunction, or significant comorbidities involving the liver, kidneys, and other organs/tissues, * With early esophageal or gastric cancer (tumor tissue has not infiltrated the muscularis propria layer), * With a history of using psychotropic or psychoactive drugs. Cohort 2: Inclusion criteria: (Patients who) * Had to meet the diagnostic criteria for esophageal or gastric cancer through clinical, pathological, and imaging examinations, * Should have no history of prior psychological intervention, * Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points, * Were required to complete the questionnaire independently or with assistance from others if needed, * Were consistently admitted to the hospital for tumor treatment, with an average time interval of approximately one month between each hospitalization, * Psychological Distress Thermometer (DT) score should be equal to or greater than 4 points, * Were of legal age, 18 years or older. Exclusion criteria: (Patients who) * With severe intellectual disabilities or other communication difficulties that hindered normal interaction, * With an expected survival time of less than 4 months, * Were Cachexia or severely debilitated, * With fractures, serious heart dysfunction, or other severe medical conditions, * With a history of using psychotropic or psychoactive drugs. Cohort 3: Inclusion criteria: * Age ≥18 years with sufficient hearing and vision capabilities, * Good activity ability, KPS score ≥80, * No history of psychological intervention, * Clear diagnosis of colorectal cancer with an expected survival of ≥6 months, * Hospital Anxiety and Depression Scale (HADS) depression score ≥8, * Sufficient ability to record and communicate independently or with family help, * Regular hospital visits for treatment or examination. Exclusion Criteria: * Known neurological diseases affecting cognition, * Previous use of medication to improve cognitive function, * Combined with other severe chronic diseases or organ damage. Termination Criteria: * Severe adverse events or reactions making it difficult to continue intervention, * Physical or mental symptoms worsen, or new symptoms emerge, making it impossible to continue intervention, * The patient wishes to stop the intervention, * More than three weeks between sessions, * Use of psychotropic drugs at the discretion of the attending physician during the intervention or waiting period, * Meeting exclusion criteria during the waiting period, * Other reasons deemed necessary by the attending physician to stop the intervention. Cohort 4: Inclusion criteria: * Diagnosis of primary non-small cell lung cancer confirmed through clinical, pathological, and imaging examinations, and awareness of their condition; * Absence of prior psychological interventions; * PFS score of ≥1; * Age of 18 years or older at the time of diagnosis and possessing adequate audiovisual capabilities to complete the questionnaire and intervention procedures. Exclusion criteria: * Individuals with severe intellectual disabilities or communication impairments; * Patients with an estimated survival time of less than 4 months; * Patients with fractures, severe cardiac insufficiency, or other serious medical conditions. Termination criteria: * Occurrence of serious adverse events or reactions hindering intervention continuation; * Patient's expressed desire to discontinue the intervention; * Inter-meeting intervals of at least three weeks; * Regular usage of fatigue or psychotropic medications as deemed appropriate by the attending physician during program implementation or the waiting period; * Compliance with exclusion criteria during the waiting period; * Any other reasons determined necessary by the attending physician to cease the intervention. Cohort 5: Inclusion criteria: * Meet the diagnostic criteria for primary NSCLC through clinical, pathological, and imaging examinations and are aware of their diagnosis; * Have not received any prior psychological intervention; * Have a FCRI-SF score of ≥13 points; * Are 18 years of age or older at the time of diagnosis and have sufficient auditory and visual abilities to complete the questionnaire tests and intervention procedures. Exclusion criteria: * Individuals with severe cognitive impairments or other communication difficulties; * Patients with an estimated survival time of less than 4 months; * Patients with fractures, severe cardiac insufficiency, or other serious comorbidities. Termination criteria: * Serious adverse events or adverse reactions that make it difficult to continue the intervention; * Patient requests to discontinue the intervention; * At least three weeks elapsing between sessions; * Regular use of fatigue or psychotropic medications, as determined by the attending physician, during the implementation of the program or during the waiting period; * Meeting the exclusion criteria during the waiting period; * Other reasons deemed necessary by the attending physician to discontinue the intervention. Cohort 6: Inclusion criteria: * Meet the diagnostic criteria for digestive system cancers (esophageal cancer, gastric cancer, or colorectal cancer) through clinical, pathological, and imaging examinations; * Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points; * Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy); * Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1); * Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy; * Informed and agreed to participate in the study; * Required to complete the questionnaire independently or with assistance from others if needed; * Legal age, 18 years or older. Exclusion criteria: * Oncogene-driver positive; * Resectable early esophageal or gastric cancer (tumor tissue has not infiltrated the muscularis propria layer); * Combined with other malignant tumors in the past 3 years; * Concurrent acute or chronic psychiatric disorders; * Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs; * Previous treatment with other clinical drug trials; * Patients with symptomatic brain metastasis; * Severe intellectual disabilities or other communication difficulties that hindered normal interaction. Termination criteria: * Serious adverse events or adverse reactions that make it difficult to continue the intervention; * Patient requests to discontinue the intervention; * Regular use of psychotropic or psychoactive drugs, as determined by the attending physician, during the implementation of the program or during the waiting period; * Other reasons deemed necessary by the attending physician to discontinue the intervention. Cohort 7: Inclusion criteria: * Meet the diagnostic criteria for NSCLC through clinical, pathological, and imaging examinations; * Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points; * Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition; * Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy); * Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1); * Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy; * Informed and agreed to participate in the study; * Required to complete the questionnaire independently or with assistance from others if needed; * Legal age, 18 years or older. Exclusion criteria: * Oncogene-driver positive; * Combined with other malignant tumors in the past 3 years; * Concurrent acute or chronic psychiatric disorders; * Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs; * Previous treatment with other clinical drug trials; * Patients with symptomatic brain metastasis; * Severe intellectual disabilities or other communication difficulties that hindered normal interaction. Termination criteria: * Serious adverse events or adverse reactions that make it difficult to continue the intervention; * Patient requests to discontinue the intervention; * Regular use of psychotropic or psychoactive drugs, as determined by the attending physician, during the implementation of the program or during the waiting period; * Other reasons deemed necessary by the attending physician to discontinue the intervention.
References
Publications (3)
- DERIVEDLi A, Huang R, Ge H, Liu D, Liu S, Jia Y, Chai J, Zheng X, Liu L, Gan C, Xu J, Cheng L, Zhang M, Cheng H. Exploring the impact and mechanisms of behavioral activation on sleep disorders in colorectal cancer: a randomized controlled trial. J Cancer Res Clin Oncol. 2024 Dec 20;151(1):12. doi: 10.1007/s00432-024-06065-x. PMID 39706981
- DERIVEDHuang R, Ge H, Nie G, Li A, Liu L, Cheng L, Zhang M, Cheng H. Effect of Behavioral Activation on Stigma and Quality of Life in Patients With Advanced Esophageal and Gastric Cancer: A Randomized Controlled Trial. Psychooncology. 2024 Nov;33(11):e70021. doi: 10.1002/pon.70021. PMID 39547955
- DERIVEDHuang R, Li A, Ge H, Liu L, Cheng L, Zhang M, Cheng H. Impacts and Pathways of Behavioral Activation on Psychological Distress Among Patients Diagnosed With Esophageal and Gastric Cancer in China: A Randomized Controlled Trial. Cancer Med. 2024 Oct;13(19):e70314. doi: 10.1002/cam4.70314. PMID 39404168