Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale, VAS
研究概览
简要总结
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.
详细描述
Study cohort:
Cohort 1: A randomized controlled trial was conducted to investigate the potential of BA in mitigating stigma among patients with advanced esophageal and gastric cancer, while also enhancing their quality of life. (Primary measure: Stigma, Secondary measure: Quality of life)
Cohort 2: A randomized controlled trial was conducted to investigate the potential of BA in mitigating psychological distress among patients with all stages of esophageal and gastric cancer and the mediating role of self-efficacy. (Primary measure: Psychological distress, Secondary measure: Anxiety symptoms, Self-efficacy, Effects of BA)
Cohort 3: A randomized controlled trial was conducted to investigate the potential of BA in mitigating depression symptoms among patients with colorectal cancer and the mediating role of physical activity. (Primary measure: Depression symptoms, Physical activity, Secondary measure: Quality of life, Psychological distress, Anxiety symptoms, Effects of BA)
Cohort 4: A randomized controlled trial was conducted to investigate the potential of BA in mitigating cancer-related fatigue among patients with non-small cell lung cancer (NSCLC). (Primary measure: Cancer-related fatigue, Secondary measure: Quality of life, Psychological distress, Depression symptoms, Anxiety symptoms, Effects of BA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
- •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.
- •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.
- •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;
- 另有 39 项未显示
结局指标
主要结局
Visual Analogue Scale, VAS
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
VAS is a widely utilized tool for pain assessment in clinical practice in China. This method involves employing a 10cm long sliding ruler, featuring 10 gradations on one side and "0" and "10" at the opposing ends. A score of 0 indicates the absence of pain, while a score of 10 represents the utmost intolerable pain.
Hospital anxiety and depression scale (HADS)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
Anxiety and depression were assessed using the HADS. The HADS scale is mainly used for screening anxiety and depression in general hospital patients. It includes two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored on a 4-level scale according to the frequency of symptoms in the past month. Each item has a total of four levels, ranging from 0 to 3, with higher scores indicating more severe anxiety or depression symptoms. The total scores for anxiety and depression are 0-21.
Pittsburgh sleep quality index (PSQI)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
The Pittsburgh Sleep Quality Index (PSQI) is used to assess subjective sleep quality over the past month. The PSQI consists of 19 self-rated items and 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, hypnosis use, and daytime dysfunction. The scores range from 0 to 3 and the total score is 0 to 21; higher scores indicate poorer sleep quality.
General Self-Efficacy Scale (GSES)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
Self-efficacy was assessed using the General Self-Efficacy Scale. The scale consists of 10 items, each of which is scored between 1 and 4, and the total score is 10-40 divided by 10. The higher the score, the higher the self-efficacy.
Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
Fear of recurrence was assessed with the Fear of Cancer Recurrence Inventory- Short Form, which consists of 9 questions and is graded on a 0 to 4 scale with a total score of 0 to 36, with higher scores indicating greater fear of recurrence, with a cutoff score of 13 for high-level FCR.
Time of Time to progression (TTP)
时间窗: 1 year
Time to progression (TTP) is the time from randomization to any aspect of tumor progression. The criteria for tumor progression are based on the RECIST 1.1 version.
Objective Response Rate (ORR)
时间窗: 1 year
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Sociodemographic data
时间窗: Day 0
The sociodemographic data includes gender, age, smoking, drinking, working, marital status, and education level. This information is extracted from the medical record.
Status of Tumor
时间窗: Day 0
The status of tumor encompasses the primary tumor site, TNM stage-based tumor staging, histological subtype of the tumor, as well as the past, present, and future treatment strategies for the neoplasm. This information is extracted from the medical record.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
Quality of life was assessed using the EORTC QLQ-C30. The EORTC QLQ-C30 is a cancer-specific tool that contains 30 items. The EORTC QLQ-C30 includes five important functional areas -- physical, emotional, role, cognitive, and social; two items assess global quality of life; three symptom scales assess fatigue, vomiting, and pain; and six subscales to assess dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties. Higher scores on the functional scales represent higher levels of functioning, meaning healthier cancer patients, while higher scores on the symptom scales or items represent higher levels of symptoms or problems, or less healthy cancer patients.
Brief Resilient Coping Scale (BRCS)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
The Brief Resilient Coping Scale was used to assess resilience. It has four items and uses a 5-point Likert scale "from '1' = does not describe me at all to '5' = describes me very much."25 The total score ranges from 4 to 20; higher scores indicate greater resilience.
Multidimensional Scale of Perceived Social Support (MSPSS)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
Social support was assessed using the Perceived Social Support Multidimensional Scale. The scale includes 12 self-rated items and uses a 7-point scoring method, with scores ranging from strongly disagree to strongly agree, with higher scores indicating higher perceived social support. This study used the scale to assess the perceived degree of support from family, friends and others.
Body Mass Index, BMI
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
The Body Mass Index (BMI) is a widely accepted international standard for assessing adiposity and overall health status in individuals. It is calculated by dividing an individual's weight by the square of their height, expressed in kilograms per square meter (kg/m\^2). This information is extracted from the medical record.
Biochemical index
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
Biochemical index includes blood glucose, triglyceride and total cholesterol, which reflect the metabolic level in the body, expressed in mmol/L. This information is extracted from the medical record. This information is extracted from the medical record.
Blood Pressure, BP
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
The measurement of blood pressure is typically presented as the ratio between systolic and diastolic pressures, expressed in millimeters of mercury (mmHg). This information is extracted from the medical record.
International physical activity questionnaire (IPAQ)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
The physical activity level was assessed by the short version of the International Physical Activity Questionnaire (IPAQ). There were seven questions in total, six of which asked about the physical activity of individuals. The question structure was the same as that of the long version of the IPQ, except for the activity intensity part. The short version of the IPQ was divided into walking, moderate intensity and high intensity to ask about the weekly frequency and cumulative time of activities of different intensity, taking into account the four physical activity levels of work, transportation, housework and gardening, and leisure. Participants were categorized into low, moderate, and high physical activity groups based on their overall level of physical activity as well as the frequency and duration of daily physical activities over a span of one week.
Social Impact Scale (SIS)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
The Social Impact Scale is used to evaluate the stigma of patients with chronic diseases such as cancer. The scale has 24 items, including 4 dimensions, which are social exclusion, economic discrimination, internal stigma and social isolation. The scale adopts the Likert 4-point scoring method, with 1-4 points from "strongly disagree" to "strongly agree", and the total score ranges from 24 to 96. The higher the score, the greater the stigma of patients.
Value of Systemic immune inflammation index (SII)
时间窗: 1 year
SII is an inflammatory indicator, which is calculated as follows: SII=(neutrophil×platelet)/lymphocytes. A higher value indicates an elevated level of inflammation within the body. This information is extracted from the medical record.
Value of Pan-immune inflammation value (PIV)
时间窗: 1 year
PIV is an inflammatory indicator, which is equal to neutrophils × monocytes × platelets/lymphocytes. The higher the value is, the higher the inflammatory level in the body is. This information is extracted from the medical record.
Concentration of Carbohydrate antigen 19-9 (CA19-9)
时间窗: 1 year
Carbohydrate antigen 19-9 (CA19-9) is a tumor marker associated with pancreatic, gallbladder, colon, and stomach cancers, with a normal value of \<37kU/L. This information is extracted from the medical record.
Nutritional Risk Screening, NRS
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
NRS is a recommended method by the European Society for Parenteral and Enteral Nutrition to assess nutritional risk in hospitalized patients, consisting of three components: nutritional status, disease severity, and age. The total score ranges from 0-7 points with higher scores indicating poorer nutritional status. A total score ≥3 points indicates the presence of nutritional risk requiring nutritional support while a total score \<3 points necessitates weekly review of the patient's nutritional assessment; if subsequent reviews yield a score ≥3 points, then initiation of the nutritional support program is warranted.
Karnofsky Performance Status Scale, KPS
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
KPS is utilized for the evaluation of cancer patients' physical condition and daily functional capacity. The total score ranges from 0 to 100, with higher scores indicating improved overall health, enhanced physical abilities, better tolerance towards treatment-related side effects, and consequently a greater potential for comprehensive therapeutic interventions.
Psychological Distress Thermometer (DT)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
Psychological distress is assessed using the DT. The DT is a self-assessment of the level of psychological distress experienced in the past week (including the day of filling in this questionnaire). It covers practical, family, emotional, spiritual/religious and physical problems. The scale ranges from 0 to 10. The higher the score, the greater the level of psychological distress or psychological distress.
Revised Piper Fatigue Scale (PFS-R)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
Cancer-related fatigue was assessed using the PFS-R. The scale consists of 22 items and 5 open-ended questions, and patients were evaluated using a scale of 0 to 10, with the final score as total score/item number. The PFS-R described four dimensions of subjective fatigue according to the following subscales: behavioral severity subscale (6 items), cognitive severity subscale, emotional meaning subscale (5 items), and sensory/emotional severity subscale (5 items). Fatigue was divided into three grades according to the score: mild fatigue (1-3 points), moderate fatigue symptoms (4-6 points), and severe fatigue symptoms (7-10 points).
The activation subscale of Behavioral Activation for Depression Scale (BADS-A)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
The effectiveness of the BA intervention was assessed using the BADS-A, a 7-item scale that allows each item to be scored on a scale of 0 to 6 (from "none at all" to "completely"), with a total score of 0 to 42. The higher the score, the better the BA intervention.
Time of Progression-free survival (PFS)
时间窗: 1 year
Progression-free survival (PFS) is the time from randomization to the first progression or death from any cause. The criteria for tumor progression are based on the RECIST 1.1 version.
Concentration of Carbohydrate antigen 72-4 (CA72-4)
时间窗: 1 year
Carbohydrate antigen 72-4 (CA72-4) is one of the tumor markers for the detection of gastric cancer and various digestive tract cancers. The detection of gastric cancer exhibits a high level of specificity, with a cut-off value set at \>6 U/mL. This information is extracted from the medical record.
The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
时间窗: Day 0, Month 1, Month 2, Month 6 and Month 12
The FACT-Cog is used to assess perceived cognitive function and its impact on quality of life in cancer patients. It includes 37 items across four dimensions (subjective cognitive impairment, evaluation by others, subjective cognitive ability, and impact of cognitive impairment on quality of life), with each item scored on a scale of 0 to 5, ranging from never/not at all (0) to several times/very often (4). The total score is 0 to 148, with lower scores indicating greater cognitive impairment.
Concentration of C-reactive protein (CRP)
时间窗: 1 year
C-reactive protein (CRP) expressed in mg/L, serves as a non-specific inflammatory biomarker with higher values indicating elevated levels of systemic inflammation. This information is extracted from the medical record.
Value of Platelet-lymphocyte ratio (PLR)
时间窗: 1 year
PLR is an inflammatory marker, a ratio of platelets to lymphocytes. A higher value of it indicates a higher level of inflammation in the body. This information is extracted from the medical record.
Value of eosinophil fraction
时间窗: 1 year
The eosinophil fraction is a potential inflammation and tumor prognostic indicator, which equals the ratio of eosinophil absolute value to the total white blood cell count. The higher the value of this fraction, the better the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally.
Concentration of Carcinoembryonic antigen (CEA)
时间窗: 1 year
Carcinoembryonic antigen (CEA) is a broad-spectrum tumor marker, commonly found in gastrointestinal tumors as well as breast and lung cancers. Normal values are generally \<5.0ng/ml. This information is extracted from the medical record.
Value of Neutrophils to lymphocytes ratio (NLR)
时间窗: 1 year
NLR is an inflammatory marker, which is the ratio of neutrophils to lymphocytes. The higher the value is, the higher the inflammatory level may be. This information is extracted from the medical record.
Value of Monocyte-lymphocyte ratio (MLR)
时间窗: 1 year
MLR is an inflammatory indicator, which is the ratio of macrophages and lymphocytes. The higher the value is, the higher the inflammatory level in the body is. This information is extracted from the medical record.
Value of prognostic nutritional index (PNI)
时间窗: 1 year
PNI is a potential inflammation and tumor prognostic indicator, which is equal to albumin level (g/L) + 5 × absolute value of lymphocyte counts. The higher the value of this index, the better the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally.
Value of the modified Glasgow prognostic score (mGPS)
时间窗: 1 year
mGPS is a potential inflammation and tumor prognostic indicator, which based on serum C-reactive protein (CRP) and albumin. Patients were assigned mGPS = 0 if normal serum C-reactive protein (CRP, ≤10 mg/L) and albumin levels (≥35 g/L) were observed. Patients were assigned mGPS = 1 if elevated CRP without hypoalbuminemia (CRP \> 10 mg/L and albumin ≥35 g/L) was diagnosed. If CRP \>10 mg/L and albumin \<35 g/L, mGPS = 2. The higher the score, the worse the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally.
Concentration of Neuron-specific enolase (NSE)
时间窗: 1 year
Neuron-specific enolase (NSE) is a specific marker for tumors such as small cell lung cancer (SCLC), with normal value \<16.3ng/ml. This information is extracted from the medical record.
Concentration of Squamous cell carcinoma associated antigen (SCC)
时间窗: 1 year
Squamous cell carcinoma associated antigen (SCC) is a tumor marker associated with squamous cell carcinomas such as lung squamous cell carcinoma and esophageal squamous cell carcinoma, with a cut-off value of 2.5μg/L. This information is extracted from the medical record.
次要结局
未报告次要终点
研究者
Huaidong Cheng
Professor
Anhui Medical University