protocolSection identificationModule nctId: NCT06348940, orgStudyIdInfo id: 83242392, briefTitle: Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-12, primaryCompletionDateStruct date: 2024-06-12, completionDateStruct date: 2024-06-12, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Anhui Medical University, class: OTHER, descriptionModule briefSummary: 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 investigators conducted a randomized controlled trial (RCT) 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 a total of 390 cancer patients, comprising 170 individuals diagnosed with esophageal and gastric cancer, 100 individuals with colorectal cancer, and 120 individuals with lung cancer. 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 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.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., conditionsModule conditions: Cancer Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 390, type: ESTIMATED, armsInterventionsModule interventions name: behavioral activation, outcomesModule primaryOutcomes measure: Sociodemographic data, primaryOutcomes measure: Status of Tumor, primaryOutcomes measure: Body Mass Index, BMI, primaryOutcomes measure: Biochemical index, primaryOutcomes measure: Blood Pressure, BP, primaryOutcomes measure: Nutritional Risk Screening, NRS, primaryOutcomes measure: Visual Analogue Scale, VAS, primaryOutcomes measure: Karnofsky Performance Status Scale, KPS, primaryOutcomes measure: Psychological Distress Thermometer (DT), primaryOutcomes measure: Hospital anxiety and depression scale (HADS), primaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), primaryOutcomes measure: Pittsburgh sleep quality index (PSQI), primaryOutcomes measure: Revised Piper Fatigue Scale (PFS-R), primaryOutcomes measure: International physical activity questionnaire (IPAQ), primaryOutcomes measure: Brief Resilient Coping Scale (BRCS), primaryOutcomes measure: Multidimensional Scale of Perceived Social Support (MSPSS), primaryOutcomes measure: General Self-Efficacy Scale (GSES), primaryOutcomes measure: The activation subscale of Behavioral Activation for Depression Scale (BADS-A), primaryOutcomes measure: Social Impact Scale (SIS), primaryOutcomes measure: Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF), primaryOutcomes measure: The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog), primaryOutcomes measure: Time of Progression-free survival (PFS), primaryOutcomes measure: Time of Time to progression (TTP), primaryOutcomes measure: Concentration of C-reactive protein (CRP), primaryOutcomes measure: Value of Neutrophils to lymphocytes ratio (NLR), primaryOutcomes measure: Value of Platelet-lymphocyte ratio (PLR), primaryOutcomes measure: Value of Monocyte-lymphocyte ratio (MLR), primaryOutcomes measure: Value of Systemic immune inflammation index (SII), primaryOutcomes measure: Value of Pan-immune inflammation value (PIV), primaryOutcomes measure: Concentration of Carcinoembryonic antigen (CEA), primaryOutcomes measure: Concentration of Carbohydrate antigen 19-9 (CA19-9), primaryOutcomes measure: Concentration of Carbohydrate antigen 72-4 (CA72-4), primaryOutcomes measure: Concentration of Neuron-specific enolase (NSE), primaryOutcomes measure: Concentration of Squamous cell carcinoma associated antigen (SCC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Affiliated Hospital of Anhui Medical University, city: Hefei, state: Anhui, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False