Trial Title:
Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients
NCT ID:
NCT06348940
Condition:
Cancer Patients
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Behavioral
Intervention name:
behavioral activation
Description:
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.
Arm group label:
Behavioral activation + Care as usual
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Country:
China
Start date:
March 12, 2023
Completion date:
December 12, 2024
Lead sponsor:
Agency:
Anhui Medical University
Agency class:
Other
Source:
Anhui Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06348940
