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

Status Active, not recruiting

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cancer Patients

• NCT number: NCT06348940
• Study type: Interventional
• Source: Anhui Medical University
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 12, 2023
• Completion date: June 12, 2024