Clinical trial NCT06348940: Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients
Official title: Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Patients
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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

Eligibility criteria: Cohort 1:

Inclusion criteria:

(Patients who)

* Had to meet the diagnostic criteria for esophageal or gastric cancer through clinical, pathological, and imaging examinations,
* Should have no history of prior psychological intervention,
* Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points,
* Were required to complete the questionnaire independently or with assistance from others if needed,
* Were consistently admitted to the hospital for tumor treatment, with an average time interval of approximately one month between each hospitalization,
* Were reporting stigma and its possible causes, the average score of the Social Impact Scale exceeded 1,
* Were of legal age, 18 years or older.

Exclusion criteria:

(Patients who)

* With severe intellectual disabilities or other communication difficulties that hindered normal interaction,
* With an expected survival time of less than 4 months,
* Were Cachexia or severely debilitated,
* With fractures, serious heart dysfunction, or significant comorbidities involving the liver, kidneys, and other organs/tissues,
* With early esophageal or gastric cancer (tumor tissue has not infiltrated the muscularis propria layer),
* With a history of using psychotropic or psychoactive drugs.

Cohort 2:

Inclusion criteria:

(Patients who)

* Had to meet the diagnostic criteria for esophageal or gastric cancer through clinical, pathological, and imaging examinations,
* Should have no history of prior psychological intervention,
* Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points,
* Were required to complete the questionnaire independently or with assistance from others if needed,
* Were consistently admitted to the hospital for tumor treatment, with an average time interval of approximately one month between each hospitalization,
* Psychological Distress Thermometer (DT) score should be equal to or greater than 4 points,
* Were of legal age, 18 years or older.

Exclusion criteria:

(Patients who)

* With severe intellectual disabilities or other communication difficulties that hindered normal interaction,
* With an expected survival time of less than 4 months,
* Were Cachexia or severely debilitated,
* With fractures, serious heart dysfunction, or other severe medical conditions,
* With a history of using psychotropic or psychoactive drugs.

Cohort 3:

Inclusion criteria:

* Age ≥18 years with sufficient hearing and vision capabilities,
* Good activity ability, KPS score ≥80,
* No history of psychological intervention,
* Clear diagnosis of colorectal cancer with an expected survival of ≥6 months,
* Hospital Anxiety and Depression Scale (HADS) depression score ≥8,
* Sufficient ability to record and communicate independently or with family help,
* Regular hospital visits for treatment or examination.

Exclusion Criteria:

* 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.

Cohort 4:

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.

Cohort 5:

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.

Cohort 6:

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;
* Required to complete the questionnaire independently or with assistance from others if needed;
* Legal age, 18 years or older.

Exclusion criteria:

* Oncogene-driver positive;
* Resectable early esophageal or gastric cancer (tumor tissue has not infiltrated the muscularis propria layer);
* Combined with other malignant tumors in the past 3 years;
* Concurrent acute or chronic psychiatric disorders;
* Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs;
* Previous treatment with other clinical drug trials;
* Patients with symptomatic brain metastasis;
* Severe intellectual disabilities or other communication difficulties that hindered normal interaction.

Termination criteria:

* Serious adverse events or adverse reactions that make it difficult to continue the intervention;
* Patient requests to discontinue the intervention;
* Regular use of psychotropic or psychoactive drugs, as determined by the attending physician, during the implementation of the program or during the waiting period;
* Other reasons deemed necessary by the attending physician to discontinue the intervention.

Cohort 7:

Inclusion criteria:

* Meet the diagnostic criteria for NSCLC through clinical, pathological, and imaging examinations;
* Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points;
* Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
* 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;
* Required to complete the questionnaire independently or with assistance from others if needed;
* Legal age, 18 years or older.

Exclusion criteria:

* Oncogene-driver positive;
* Combined with other malignant tumors in the past 3 years;
* Concurrent acute or chronic psychiatric disorders;
* Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs;
* Previous treatment with other clinical drug trials;
* Patients with symptomatic brain metastasis;
* Severe intellectual disabilities or other communication difficulties that hindered normal interaction.

Termination criteria:

* Serious adverse events or adverse reactions that make it difficult to continue the intervention;
* Patient requests to discontinue the intervention;
* Regular use of psychotropic or psychoactive drugs, as determined by the attending physician, during the implementation of the program or during the waiting period;
* Other reasons deemed necessary by the attending physician to discontinue the intervention.

Primary outcomes:
measure: Sociodemographic data
timeFrame: Day 0
measure: Status of Tumor
timeFrame: Day 0
measure: Body Mass Index, BMI
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Biochemical index
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Blood Pressure, BP
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Nutritional Risk Screening, NRS
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Visual Analogue Scale, VAS
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Karnofsky Performance Status Scale, KPS
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Psychological Distress Thermometer (DT)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Revised Piper Fatigue Scale (PFS-R)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: International physical activity questionnaire (IPAQ)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Brief Resilient Coping Scale (BRCS)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: General Self-Efficacy Scale (GSES)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: The activation subscale of Behavioral Activation for Depression Scale (BADS-A)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Social Impact Scale (SIS)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
timeFrame: Day 0, Month 1, Month 2, Month 6 and Month 12
measure: Time of Progression-free survival (PFS)
timeFrame: 1 year
measure: Time of Time to progression (TTP)
timeFrame: 1 year
measure: Objective Response Rate (ORR)
timeFrame: 1 year
measure: Concentration of C-reactive protein (CRP)
timeFrame: 1 year
measure: Value of Neutrophils to lymphocytes ratio (NLR)
timeFrame: 1 year
measure: Value of Platelet-lymphocyte ratio (PLR)
timeFrame: 1 year
measure: Value of Monocyte-lymphocyte ratio (MLR)
timeFrame: 1 year
measure: Value of Systemic immune inflammation index (SII)
timeFrame: 1 year
measure: Value of Pan-immune inflammation value (PIV)
timeFrame: 1 year
measure: Value of eosinophil fraction
timeFrame: 1 year
measure: Value of prognostic nutritional index (PNI)
timeFrame: 1 year
measure: Value of the modified Glasgow prognostic score (mGPS)
timeFrame: 1 year
measure: Concentration of Carcinoembryonic antigen (CEA)
timeFrame: 1 year
measure: Concentration of Carbohydrate antigen 19-9 (CA19-9)
timeFrame: 1 year
measure: Concentration of Carbohydrate antigen 72-4 (CA72-4)
timeFrame: 1 year
measure: Concentration of Neuron-specific enolase (NSE)
timeFrame: 1 year
measure: Concentration of Squamous cell carcinoma associated antigen (SCC)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
References: