A Longitudinal Study of Phased Psychological Intervention on Psychological Adjustment in Cancer Patients During ICU Stay and Recovery

Summary

This protocol aims to longitudinally track and improve cancer ICU patients' psychological adaptation by evaluating staged, personalized intervention's impact on anxiety, depression, resilience, post-traumatic stress disorder (PTSD), and quality of life.

Abstract

This protocol presents a longitudinal study designed to evaluate a phased psychological intervention for cancer patients during, and after intensive care unit (ICU) stay. The intervention is structured in three stages: (1) acute-phase cognitive-behavioral therapy (CBT) during ICU hospitalization, (2) transitional-phase meaning-centered Managing Cancer And Living Meaningfully (CALM) therapy post-discharge, and (3) long-term family support and community linkage. A total of 120 cancer ICU patients will be allocated to either the staged intervention group, or standard care. Psychological adjustment outcomes-including anxiety, depression, post-traumatic stress disorder (PTSD), resilience, and quality of life-will be assessed longitudinally from baseline to 24 months post-discharge. The study aims to provide a structured, evidence-based psychological care pathway for ICU cancer patients, with potential implications for integrated psycho-oncology care models.

Introduction

The intensive care unit (ICU) environment, essential for treating critically ill patients, presents significant psychological challenges that can impede recovery. For cancer patients, these challenges are compounded by the inherent stress of their diagnosis and treatment, leading to complex psychological crises such as anxiety, depression, and post-traumatic stress disorder (PTSD), which often persist long after discharge^1,2,3. While the importance of psychological support in critical care is increasingly recognized, significant gaps remain in understanding the dynamic psychological needs of ICU cancer patients and in developing effective, tailored intervention strategies.

Existing psychological interventions in the ICU often fall short due to several limitations. Many approaches are applied homogenously, failing to account for the unique and evolving psychological trajectory of a patient from the acute phase of critical illness to long-term recovery. Interventions are frequently focused on single, short-term outcomes, such as immediate anxiety reduction, with insufficient evidence of long-term benefits or sustained improvements in quality of life^4,5. Furthermore, many studies lack a systematic design that addresses the multidimensional nature of psychological distress, which includes not only the patient's emotional state but also their existential concerns and the role of their family support system⁶. This results in fragmented care where response rates can be low, and intervention effects may diminish over time.

There is, therefore, a clear methodological need for a more structured, comprehensive, and longitudinal approach to psychological care for this vulnerable population. An ideal protocol would be staged to match the patient's journey-addressing acute distress in the ICU, facilitating meaning-making during transition, and supporting social reintegration during recovery. This study protocols a novel, phased psychological intervention designed to address this gap. Our program uniquely integrates Cognitive Behavioral Therapy (CBT) in the acute phase, meaning-centered CALM therapy in the transitional phase, and continuous family support activation. This design is based on the hypothesis that a staged, personalized intervention can more effectively reduce long-term psychological morbidity and improve quality of life compared to standard care. This study aims to evaluate the long-term efficacy of this intervention on anxiety, depression, PTSD, resilience, and quality of life in cancer patients from their ICU stay up to 24 months post-discharge, providing evidence for a more precise and effective psychological rehabilitation pathway.

Protocol

1. Ethics and consent

1. Submit the complete study protocol to the Ethics Committee of the Henan Vocational College of Nursing for review.
2. Ensure the study receives formal approval (Approval Number: 20141124) prior to initiation of any procedures.
3. Present a detailed written informed consent form to each potential participant prior to any study-related activities.
4. For patients lacking decision-making capacity, present the consent form to their legally authorized representative or guardian.

2. Participant selection and group allocation

1. Cohort identification
   1. Conduct a retrospective review of electronic medical records to identify all adult cancer patients admitted to the hospital's ICU between January 2021 and June 2023.
   2. Document the screening and allocation process using a flowchart (Figure 1).
2. Eligibility application
   1. Apply the following inclusion criteria: age ≥18 years; basic literacy; intact cognition (Glasgow Coma Score ≥13, Mini-Mental State Examination ≥24); confirmed malignancy diagnosis; expected ICU stay ≥5 days; receiving standard ICU treatment; no severe organ dysfunction (APACHE II ≤25); expected survival ≥24 months; and provision of informed consent for participation and follow-up.
   2. Apply the following exclusion criteria: pre-existing severe cognitive impairment or psychiatric disorder; severe sensory or communication deficits; uncontrolled severe pain (Visual Analog Scale ≥7); concurrent structured psychotherapy; receiving palliative sedation; plans to relocate outside the study area; inability to complete follow-ups; or significant family/judicial conflicts.

3. Intervention procedures

1. Control group protocol
   1. Provide all participants with routine medical and nursing care according to standard ICU and oncology protocols.
   2. Provide basic, unstructured psychological support.
      1. Instruct attending physicians to offer brief daily updates (approx. 5 minutes) on treatment progress.
      2. Instruct nurses to employ active listening and general reassurance during care activities.
   3. Exclude the delivery of any structured psychological therapy, family workshops, or digital interventions to this group.
2. Experimental group protocol
   1. Form a multidisciplinary intervention team.
      1. Assemble a team comprising a licensed psychotherapist, ICU specialist nurses, a clinical social worker, and consulting oncologists.
      2. Ensure the lead psychotherapist holds a minimum of a master's degree in clinical psychology or psychotherapy, with certification and documented supervised training in both Cognitive Behavioral Therapy (CBT) and CALM therapy.
      3. Ensure the social worker is trained in family systems theory and crisis intervention.
   2. Conduct weekly case review meetings.
      1. Hold weekly meetings for the team to review patient progress.
      2. Adjust individualized intervention strategies based on team discussion and patient response.
   3. Conduct initial psychological stratification.
      1. Administer the hospital anxiety and depression scale (HADS) and post-traumatic stress checklist (PCL-C) at baseline (ICU admission).
      2. Stratify patients into subgroups based on cut-off scores: high anxiety (HADS-A ≥11), high depression (HADS-D ≥8), and/or high PTSD risk (PCL-C ≥38).
   4. Implement ICU phase interventions (During hospitalization).
      1. Deliver manualized cognitive behavioral therapy (CBT).
         1. Instruct the trained psychotherapist to conduct daily 20-30 minute bedside CBT sessions.
         2. Adhere to a standardized CBT protocol adapted for the critically ill, focusing on techniques from Beck's cognitive model.
         3. Guide the patient to identify and record disease-related negative automatic thoughts (NATs). Example NAT: "I will never recover from this; this ICU stay means the end."
         4. Use socratic questioning to collaboratively evaluate the evidence for and against these NATs. Example questions: "What is the evidence that supports this thought? What is the evidence against it? Is there an alternative, less catastrophic way of viewing this situation?"
         5. Collaborate with the patient to develop balanced, adaptive cognitions. Example adaptive response: "While this is a serious situation, I am in the best place to receive care. Many people recover from critical illnesses. My focus today is on getting through this procedure."
         6. Implement behavioral activation techniques, such as scheduling small, achievable activities (e.g., listening to music for 10 minutes, engaging in brief conversation).
      2. Provide anxiety management training.
         1. Teach the patient progressive muscle relaxation (PMR) for physiological anxiety alleviation.
         2. Guide the patient through a standardized PMR script, tensing and relaxing major muscle groups sequentially, as described in interventions for medical populations.
         3. Provide an audio recording of the PMR guide for independent practice.
      3. Provide death education and narrative processing.
         1. Arrange for two individualized 15-minute sessions per week led by a trained member of the palliative care team.
         2. Use the patient's medical reports to explain their condition and realistic treatment goals in an empathetic manner.
         3. Employ narrative medicine techniques. Encourage the patient to share their illness story. Use prompts like: "Can you tell me about your life before this illness? How has this cancer journey changed you or what is important to you? What gives you strength during this difficult time?" Actively listen and reflect to help process existential fears and death anxiety.
   5. Activate the family support system (Prior to discharge).
      1. Organize a 45-60 minute pre-discharge meeting involving the patient, primary caregiver(s), and key team members (psychotherapist, nurse, social worker).
      2. During this meeting, clarify and assign specific post-discharge care roles (e.g., medication management, appointment scheduling, emotional support).
      3. Train family members in basic, essential nursing skills relevant to the patient's condition (e.g., wound care observation, pain assessment using the Visual Analog Scale).
      4. Teach family members simple crisis coping strategies, such as grounding techniques for managing patient anxiety.
   6. Implement transitional phase interventions (0-3 Months post-discharge).
      1. Deliver CALM therapy (Managing cancer and living meaningfully).
         1. Conduct monthly 60-minute individual CALM sessions via secure video call or in-person.
         2. Follow the manualized 4-domain CALM protocol: 1) Symptom management and communication with healthcare providers, 2) Changes in self-concept and relationships, 3) Spirituality, sense of meaning and purpose, 4) Planning for the future and sustaining hope.
      2. Implement the Family Support Program.
         1. Invite family members to monthly 90-minute psychological workshops (in-person or virtual).
         2. Structure workshops to cover topics like caregiver emotional regulation, family stress management, effective communication with the patient, and caregiver self-care, using role-playing and group discussions.
   7. Implement Long-Term Recovery Phase Interventions (3-24 Months post-discharge).
      1. Establish community linkage support.
         1. At the 3-month post-discharge point, formally connect the patient and family with a partnered community social work organization.
         2. The community organization provides quarterly group counseling sessions focusing on shared experiences and social reintegration.
      2. Utilize a digital intervention platform.
         1. Employ a dedicated mobile application named "MindCare Companion" (developed by a health technology partner, compatible with iOS and Android platforms, version 2.1 or above).
         2. The application is configured to deliver pre-recorded supportive audio content.
         3. Program the application to push three audio sessions per week to participants.
         4. Design audio sessions to be 10-15 minutes long. Example session content includes: guided positive imagery exercises, cognitive restructuring prompts for common post-ICU thoughts, brief mindfulness meditations, and psychoeducation on managing fatigue or sleep disturbances.
         5. Monitor participant engagement (e.g., login frequency, audio completion rates) through the application's built-in analytics dashboard.

4. Assessment Procedures and Schedule

1. Collect baseline data.
   1. Prior to intervention initiation, collect comprehensive data including demographic, socioeconomic, occupational, and clinical characteristics.
   2. Record laboratory indicators and comorbidity information.
2. Administer the hospital anxiety and depression scale (HADS)⁷ at all assessment timepoints: baseline (T0), pre-discharge (T1), and 3 (T2), 6 (T3), 12 (T4), and 24 (T5) months post-discharge.
3. Administer the post-traumatic stress checklist-civilian version (PCL-C)⁸ at T0, T1, T2, T3, T4, and T5.
4. Administer the European organization for research and treatment of cancer quality of Life questionnaire (QLQ-C30)⁹ at T0, T1, T2, T3, T4, and T5.
5. Administer the connor-davidson resilience scale-10 item (CD-RISC-10)¹⁰ at T0, T1, T2, T3, T4, and T5.
6. Administer the family APGAR Scale¹¹ at T0, T1, T2, T3, T4, and T5.

5. Study implementation and data integrity

1. Ensure fidelity of psychological interventions.
   1. Use a standardized, published CBT manual adapted for acute medical settings to guide ICU-phase therapy.
   2. Use the official CALM therapy manual for the transitional phase interventions.
   3. Monitor fidelity using a therapist-completed checklist after each CBT or CALM session, detailing duration, core components covered, and patient engagement.
   4. Conduct regular peer supervision sessions and review random audio recordings of sessions to ensure adherence to protocols and consistency across therapists.
2. Perform a contamination check
   1. At the 3-month follow-up (T2), informally interview control group participants.
   2. Ask specifically if they received any structured psychological therapy similar to the study intervention from external sources during the follow-up period.
3. Document assessment completion
   1. Record participation and completion status for all assessments at each time point (T0-T5).
   2. Document reasons for any missing data.
4. Standardize assessment administration
   1. For in-hospital assessments (T0, T1), have a trained research nurse present to clarify items if needed and ensure independent completion.
   2. Conduct all follow-up assessments (T2-T5) via structured telephone interviews using identical scripts.
   3. Train all interviewers using standardized materials and assess inter-rater reliability on practice cases to achieve > 95% concordance before study onset.
5. Adhere to the statistical analysis protocol.
   1. Verify normality of continuous data using Shapiro-Wilk tests and homogeneity of variances using Levene's test.
   2. Compare continuous outcome variables between groups at each time point using independent samples t-tests (if assumptions met).
   3. Compare categorical baseline variables using Pearson's χ² or Fisher's exact tests.
   4. Apply a Bonferroni correction for multiple comparisons across the five follow-up time points for each primary outcome, using an adjusted alpha level of P < 0.01 for significance interpretation.

Results

Comparison of baseline information

The final analytic sample comprised 120 critically ill cancer patients, randomly distributed between the experimental and control conditions, with 60 participants in each treatment arm. Comparison of the baseline characteristics between the two groups showed that the patients' psychological status presented clinically significant abnormalities, and the HADS scores of the patients in both groups exceeded the clinical threshold (HADS-A > 11 ...

Discussion

This study implemented a phased, multidisciplinary psychological intervention protocol for cancer patients during and after ICU stay, demonstrating significant long-term improvements across multiple psychosocial outcomes compared to standard care.

The intervention's success relied on several key protocol-driven steps. First, the initial psychological stratification using HADS and PCL-C at ICU admission enabled timely, tailored targeting of predominant anxiety, depression, or PTSD symptoms ...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
CALM Therapy Manual	Managing Cancer And Living Meaningfully (CALM) Program Developers	Adapted from Rodin et al. (2018)	Structured therapy manual adapted for post-discharge phase, focusing on four domains: symptom management, self-concept/relationships, meaning/purpose, and future planning/hope.
Connor-Davidson Resilience Scale (CD-RISC-10)	Connor & Davidson	10-Item Abridged Version	10-item unidimensional self-report scale measuring psychological resilience.
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)	EORTC Quality of Life Group	Version 3.0 (Chinese Version)	30-item cancer-specific health-related quality of life questionnaire. Contains functional, symptom, and global health/QoL scales.
Family APGAR Scale	Smilkstein, G.	N/A (Public Domain Instrument)	5-item questionnaire assessing patient satisfaction with family support across five domains: Adaptation, Partnership, Growth, Affection, and Resolve.
Hospital Anxiety and Depression Scale (HADS)	Zigmond & Snaith	N/A	14-item self-report questionnaire for screening anxiety (HADS-A) and depression (HADS-D) in non-psychiatric hospital settings.
Mini-Mental State Examination (MMSE)	Folstein, M.F. et al.	Chinese Version	30-point questionnaire used to screen for cognitive impairment.
Post-Traumatic Stress Disorder Checklist – Civilian Version (PCL-C)	Weathers, F.W. et al. / National Center for PTSD	N/A	17-item self-report measure assessing PTSD symptom severity based on DSM-IV criteria.
Statistical Analysis Software	IBM SPSS	Version 26.0	Used for all statistical analyses, including descriptive statistics, t-tests, chi-square tests, and ANOVA.
Visual Analog Scale (VAS) Ruler	Generic Medical Supplier	N/A	Used for pain assessment (0-10 scale).