Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348940
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-03-23
Brief Title:
Effects of Behavioral Activation on Negative Emotions Cancer-related Symptoms and Clinical Indicators in Cancer Patients
Sponsor:
Anhui Medical University
Organization:
Anhui Medical University
Study Overview
Official Title:
Effects of Behavioral Activation on Negative Emotions Cancer-related Symptoms and Clinical Indicators in Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 activationcare as usual BACAU 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 eg 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 httpswwwwjxcn 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 hospitals 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
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 activationcare as usual BACAU 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 eg 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 httpswwwwjxcn 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 hospitals 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
Detailed Description:
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
Cohort 5 A randomized controlled trial was conducted to investigate the potential of BA in mitigating fear of cancer recurrence among patients with non-small cell lung cancer NSCLC Primary measure Fear of cancer recurrence Secondary measure Quality of life Psychological distress Depression symptoms Anxiety symptoms Social Support Self-efficacy
Cohort 6 A prospective cohort study was conducted to investigate the potential of BA in alleviating emotional distress reducing inflammation markers and improving outcomes in patients with advanced digestive system cancers esophageal cancer gastric cancer and colorectal cancer receiving first-line Immune Checkpoint Inhibitors ICIs therapy through the categorization into three groups those experiencing pre-treatment emotional distress without BA intervention those experiencing pre-treatment emotional distress with BA intervention and those without pre-treatment emotional distress without BA intervention Primary measure Progression-Free Survival PFS
Cohort 7 A prospective cohort study was conducted to investigate the potential of BA in alleviating emotional distress reducing inflammation markers and improving outcomes in patients with non-small cell lung cancer NSCLC receiving first-line Immune Checkpoint Inhibitors ICIs therapy through the categorization into three groups those experiencing pre-treatment emotional distress without BA intervention those experiencing pre-treatment emotional distress with BA intervention and those without pre-treatment emotional distress without BA intervention Primary measure Progression-Free Survival PFS
Study procedure
This study was evaluated by experts in the field including two psychologists and one oncologist to ensure its scientificity 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 examiners 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 BACAU 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 1Discussion of Depression 2Introduction to Treatment Rationale What about stressful life events and loss in participants life 3Introduction to Daily Monitoring 1 Importance and enjoyment or meaning and happiness ratings 2 When should participants complete the Daily Monitoring Form 4Important Points About the Structure of This Treatment Complete Daily Monitoring Form Session 2 Special session Via telephone or Wechat 1Daily Monitoring Review Assignment Troubleshooting 2Treatment Rationale Review 3Complete 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 1Daily Monitoring Review Assignment 2Life Areas Values and Activities Inventory Review assignment 3Activity Selection and Ranking 1Daily monitoring 2Continue 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 1Daily Monitoring Review Assignment 2Daily Monitoring with Activity Planning Daily Monitoring with activity planning for upcoming week Session 5 Special session Via telephone or Wechat 1Daily Monitoring With Activity Planning Review Assignment 2Contract Ensure the timely completion of activities through effective collaboration with other people 3Daily Monitoring With Activity Planning for the Upcoming Week 1Daily monitoring with activity planning for the upcoming week 2Continue addingediting contracts Session 6 Maintenance Session Via telephone or Wechat 1Daily Monitoring With Activity Planning Review Assignment 2Life Areas Values and Activities Inventory Concept Review and Edit 3Daily Monitoring With Activity Planning for the Upcoming Week 1Daily monitoring with activity planning for the upcoming week 2Continue addingediting Contracts Session 7 Maintenance Session Via telephone or Wechat 1Daily Monitoring With Activity Planning Review Assignment 2Life Areas Values and Activities Inventory Concept Review and Edit 3Daily Monitoring With Activity Planning for the Upcoming Week 1Daily monitoring with activity planning for the upcoming week 2Continue addingediting contracts Session 8 Maintenance Session Via telephone or Wechat 1Daily Monitoring With Activity Planning Review Assignment 2Daily Monitoring With Activity Planning for the Upcoming Week 3Preparing for the End of Treatment 1Daily monitoring with activity planning for the upcoming week 2Continue addingediting contracts
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
Cohort 5 A randomized controlled trial was conducted to investigate the potential of BA in mitigating fear of cancer recurrence among patients with non-small cell lung cancer NSCLC Primary measure Fear of cancer recurrence Secondary measure Quality of life Psychological distress Depression symptoms Anxiety symptoms Social Support Self-efficacy
Cohort 6 A prospective cohort study was conducted to investigate the potential of BA in alleviating emotional distress reducing inflammation markers and improving outcomes in patients with advanced digestive system cancers esophageal cancer gastric cancer and colorectal cancer receiving first-line Immune Checkpoint Inhibitors ICIs therapy through the categorization into three groups those experiencing pre-treatment emotional distress without BA intervention those experiencing pre-treatment emotional distress with BA intervention and those without pre-treatment emotional distress without BA intervention Primary measure Progression-Free Survival PFS
Cohort 7 A prospective cohort study was conducted to investigate the potential of BA in alleviating emotional distress reducing inflammation markers and improving outcomes in patients with non-small cell lung cancer NSCLC receiving first-line Immune Checkpoint Inhibitors ICIs therapy through the categorization into three groups those experiencing pre-treatment emotional distress without BA intervention those experiencing pre-treatment emotional distress with BA intervention and those without pre-treatment emotional distress without BA intervention Primary measure Progression-Free Survival PFS
Study procedure
This study was evaluated by experts in the field including two psychologists and one oncologist to ensure its scientificity 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 examiners 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 BACAU 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 1Discussion of Depression 2Introduction to Treatment Rationale What about stressful life events and loss in participants life 3Introduction to Daily Monitoring 1 Importance and enjoyment or meaning and happiness ratings 2 When should participants complete the Daily Monitoring Form 4Important Points About the Structure of This Treatment Complete Daily Monitoring Form Session 2 Special session Via telephone or Wechat 1Daily Monitoring Review Assignment Troubleshooting 2Treatment Rationale Review 3Complete 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 1Daily Monitoring Review Assignment 2Life Areas Values and Activities Inventory Review assignment 3Activity Selection and Ranking 1Daily monitoring 2Continue 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 1Daily Monitoring Review Assignment 2Daily Monitoring with Activity Planning Daily Monitoring with activity planning for upcoming week Session 5 Special session Via telephone or Wechat 1Daily Monitoring With Activity Planning Review Assignment 2Contract Ensure the timely completion of activities through effective collaboration with other people 3Daily Monitoring With Activity Planning for the Upcoming Week 1Daily monitoring with activity planning for the upcoming week 2Continue addingediting contracts Session 6 Maintenance Session Via telephone or Wechat 1Daily Monitoring With Activity Planning Review Assignment 2Life Areas Values and Activities Inventory Concept Review and Edit 3Daily Monitoring With Activity Planning for the Upcoming Week 1Daily monitoring with activity planning for the upcoming week 2Continue addingediting Contracts Session 7 Maintenance Session Via telephone or Wechat 1Daily Monitoring With Activity Planning Review Assignment 2Life Areas Values and Activities Inventory Concept Review and Edit 3Daily Monitoring With Activity Planning for the Upcoming Week 1Daily monitoring with activity planning for the upcoming week 2Continue addingediting contracts Session 8 Maintenance Session Via telephone or Wechat 1Daily Monitoring With Activity Planning Review Assignment 2Daily Monitoring With Activity Planning for the Upcoming Week 3Preparing for the End of Treatment 1Daily monitoring with activity planning for the upcoming week 2Continue addingediting contracts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None