Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients

Cancer Patients Clinical Trial

Official title:

Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06348940
• Other study ID #: 83242392
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 12, 2023
• Est. completion date: June 12, 2024

Study information

• Verified date: April 2024
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study was evaluated by experts in the field, including two psychologists and one oncologist to ensure its scientifcity and feasibility. The BA intervention was administered 8 times, once a week. Each session lasted for 15-30 min. All the interventions were conducted by the same psychological consultant. The first BA intervention for each patient was conducted in person, with a psychological consultant in a separate treatment room. Thereafter, the psychological intervention sessions for most patients were conducted via audio calls or video conferencing means (WeChat or phone). With informed consent from all participants, each audio call was recorded, and these recordings served as the basis for the examiner's assessment of the quality of the intervention. If the BA intervention could not be conducted at the scheduled time due to patients' physical condition or other reasons, it was rescheduled within 3 to 5 days from the specified intervention time. In addition to the BA intervention, the BA+CAU group received comparable cancer care and treatment to that of the control group.

The aim of BA is to promote engagement in meaningful and pleasurable activities while reducing those that perpetuate negative emotional cycles. The investigators developed a 8-week program based on the Brief Behavioral Activation Treatment for Depression: Revised Treatment Manual. Patients were assessed weekly and instructed to keep track of their activities from the past week, rating each activity for its level of pleasure and meaning, as well as providing an overall rating for the week. Based on these scores, patients can identify which activities are beneficial or detrimental to their mental health and create a plan to increase positive activities in the following week. If they encounter difficulties achieving these goals, the investigators encourage them to break down larger objectives into smaller specific tasks or make "contracts" with others for support. Additionally, if patients are less active, the investigators suggest selecting some activities from our list (family, social, religious, etc.) as targets.

8-week program

Sessions Key elements Weekly Assignments Session1 (Special session) Offline intervention 1.Discussion of Depression 2.Introduction to Treatment Rationale. What about stressful life events and loss in participant's life? 3.Introduction to Daily Monitoring: (1) Importance and enjoyment (or meaning and happiness) ratings. (2) When should participants complete the Daily Monitoring Form? 4.Important Points About the Structure of This Treatment Complete Daily Monitoring Form Session 2 (Special session) Via telephone or Wechat: 1.Daily Monitoring: Review Assignment, Troubleshooting 2.Treatment Rationale: Review 3.Complete Life Areas, Values, Activities Inventory (Appendix) 1. Complete Daily Monitoring 2. Review and edit Life Areas, Values, and Activities Inventory Session 3 (Special session) Via telephone or Wechat: 1.Daily Monitoring: Review Assignment 2.Life Areas, Values, and Activities Inventory: Review assignment 3.Activity Selection and Ranking 1.Daily monitoring 2.Continue to review and edit Life Areas, Values, and Activities Inventory 3. Review and edit activity selection and ranking Session 4 (Special session) Via telephone or Wechat: 1.Daily Monitoring: Review Assignment 2.Daily Monitoring with Activity Planning Daily Monitoring with activity planning for upcoming week Session 5 (Special session) Via telephone or Wechat: 1.Daily Monitoring With Activity Planning: Review Assignment 2.Contract: Ensure the timely completion of activities through effective collaboration with other people 3.Daily Monitoring With Activity Planning for the Upcoming Week 1.Daily monitoring with activity planning for the upcoming week 2.Continue adding/editing contracts Session 6 (Maintenance Session) Via telephone or Wechat: 1.Daily Monitoring With Activity Planning: Review Assignment 2.Life Areas, Values, and Activities Inventory: Concept Review and Edit 3.Daily Monitoring With Activity Planning for the Upcoming Week 1.Daily monitoring with activity planning for the upcoming week 2.Continue adding/editing Contracts Session 7 (Maintenance Session) Via telephone or Wechat: 1.Daily Monitoring With Activity Planning: Review Assignment 2.Life Areas, Values, and Activities Inventory: Concept Review and Edit 3.Daily Monitoring With Activity Planning for the Upcoming Week 1.Daily monitoring with activity planning for the upcoming week 2.Continue adding/editing contracts Session 8 (Maintenance Session) Via telephone or Wechat: 1.Daily Monitoring With Activity Planning: Review Assignment 2.Daily Monitoring With Activity Planning for the Upcoming Week 3.Preparing for the End of Treatment 1.Daily monitoring with activity planning for the upcoming week 2.Continue adding/editing contracts

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: June 12, 2024
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet the diagnostic criteria for cancer (including esophageal, gastric, colorectal or lung cancer) through clinical, pathological, and imaging examinations

• No history of prior psychological intervention

• Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points

• Required to complete the questionnaire independently or with assistance from others if needed

• Consistently admitted to the hospital for tumor treatment, with an average time interval of approximately one month between each hospitalization

• Reporting negative emotional or physical symptoms that meet certain objective criteria

• Legal age, 18 years or older.

Exclusion Criteria:

• Severe intellectual disabilities or other communication difficulties that hindered normal interaction

• An expected survival time of less than 4 months

• Cachexia or severely debilitated

• Fractures, serious heart dysfunction, or other severe medical conditions

• A history of using antipsychotics.

Related Conditions & MeSH terms

• Cancer Patients

Intervention

Behavioral:
• behavioral activation
Behavioral activation, an emerging psychological intervention approach, has potential in alleviating negative emotions among cancer patients. The intervention group underwent an eight-week behavioral activation program designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles.

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sociodemographic data	The sociodemographic data includes gender, age, smoking, drinking, working, marital status, and education level. This information is extracted from the medical record.	Day 0
Primary	Status of Tumor	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.	Day 0
Primary	Body Mass Index, BMI	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.	Day 0, Month 1, and Month 2
Primary	Biochemical index	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.	Day 0, Month 1, and Month 2
Primary	Blood Pressure, BP	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.	Day 0, Month 1, and Month 2
Primary	Nutritional Risk Screening, NRS	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.	Day 0, Month 1, and Month 2
Primary	Visual Analogue Scale, VAS	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.	Day 0, Month 1, and Month 2
Primary	Karnofsky Performance Status Scale, KPS	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.	Day 0, Month 1, and Month 2
Primary	Psychological Distress Thermometer (DT)	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.	Day 0, Month 1, and Month 2
Primary	Hospital anxiety and depression scale (HADS)	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.	Day 0, Month 1, and Month 2
Primary	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	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.	Day 0, Month 1, and Month 2
Primary	Pittsburgh sleep quality index (PSQI)	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.	Day 0, Month 1, and Month 2
Primary	Revised Piper Fatigue Scale (PFS-R)	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).	Day 0, Month 1, and Month 2
Primary	International physical activity questionnaire (IPAQ)	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.	Day 0, Month 1, and Month 2
Primary	Brief Resilient Coping Scale (BRCS)	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.	Day 0, Month 1, and Month 2
Primary	Multidimensional Scale of Perceived Social Support (MSPSS)	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.	Day 0, Month 1, and Month 2
Primary	General Self-Efficacy Scale (GSES)	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.	Day 0, Month 1, and Month 2
Primary	The activation subscale of Behavioral Activation for Depression Scale (BADS-A)	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.	Day 0, Month 1, and Month 2
Primary	Social Impact Scale (SIS)	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.	Day 0, Month 1, and Month 2
Primary	Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)	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.	Day 0, Month 1, and Month 2
Primary	The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)	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.	Day 0, Month 1, and Month 2
Primary	Time of Progression-free survival (PFS)	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.	Day 0, Month 1, and Month 2
Primary	Time of Time to progression (TTP)	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.	Day 0, Month 1, and Month 2
Primary	Concentration of C-reactive protein (CRP)	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.	Day 0, Month 1, and Month 2
Primary	Value of Neutrophils to lymphocytes ratio (NLR)	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.	Day 0, Month 1, and Month 2
Primary	Value of Platelet-lymphocyte ratio (PLR)	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.	Day 0, Month 1, and Month 2
Primary	Value of Monocyte-lymphocyte ratio (MLR)	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.	Day 0, Month 1, and Month 2
Primary	Value of Systemic immune inflammation index (SII)	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.	Day 0, Month 1, and Month 2
Primary	Value of Pan-immune inflammation value (PIV)	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.	Day 0, Month 1, and Month 2
Primary	Concentration of Carcinoembryonic antigen (CEA)	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.	Day 0, Month 1, and Month 2
Primary	Concentration of Carbohydrate antigen 19-9 (CA19-9)	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.	Day 0, Month 1, and Month 2
Primary	Concentration of Carbohydrate antigen 72-4 (CA72-4)	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.	Day 0, Month 1, and Month 2
Primary	Concentration of Neuron-specific enolase (NSE)	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.	Day 0, Month 1, and Month 2
Primary	Concentration of Squamous cell carcinoma associated antigen (SCC)	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.	Day 0, Month 1, and Month 2