Cancer And Living Meaningfully Research Articles

Managing Cancer and Living Meaningfully (CALM) in Adults with Brain Metastases: A NIH ORBIT Model Phase II Feasibility and Proof-of-Concept Trial

Abstract Background Managing Cancer and Living Meaningfully (CALM) is a brief, evidence-based psychotherapy designed to help patients with advanced cancer cope with the practical and profound challenges of their illness. However, no study has systematically examined CALM in adults with brain metastases, despite the well-documented incidence of distress in this growing population. The primary aim of this trial was to assess the feasibility and acceptability of CALM in adults with brain metastases. Methods Patients with brain metastases (N=13) and elevated symptoms of depression and/or death anxiety enrolled in this single-arm trial. CALM was administered in six biweekly sessions, with outcomes assessed at baseline and post-intervention. Feasibility was assessed based on established metrics including enrollment and retention rates. Acceptability was measured by post-session surveys and post-intervention interviews. Preliminary signal change on measures of psychological distress was explored. Results Of the 13 enrolled participants, 11 completed baseline assessments and initiated treatment: 73% female, Mage=58 years (SD=12.9; range=37-75). Nine completed the study (81% retention rate). Overall, participants reported high perceived benefit and would recommend the program to others. Baseline to post-intervention assessments indicated improvements in depression, death anxiety, generalized anxiety, post-traumatic stress, suicidal ideation, and spiritual well-being. Life quality, substance use, and fear of cancer recurrence remained relatively stable. Conclusions CALM is feasible and acceptable and may improve psychological distress in adults with brain metastases. The findings of this study align with our previous trial of patients with malignant glioma and support a future NIH ORBIT Phase II randomized pilot trial of CALM in neuro-oncology.

Perceived social support mediates cancer and living meaningfully intervention effects on quality of life after breast cancer surgery.

Aim: To explore the role of perceived social support in enhancing psychological resilience and quality of life in postoperative breast cancer patients.Materials & methods: The Managing Cancer and Living Meaningfully (CALM) intervention was used to improve indicators such as psychological resilience in breast cancer patients, while the role of perceived social support in this was assessed.Results: The intervention group exhibited significant improvements compared with the control group in psychological resilience (F=9.059, p<0.01). The analysis showed that increased social support in the control group partly mediated the link between psychological resilience and quality of life.Conclusion: CALM improves overall well-being, indicating that incorporating it into standard care for post-mastectomy patients can positively impact their mental health.

Psycho-oncological interventions for patients in palliative care: managing cancer and living meaningfully (CALM)

Psycho-oncological interventions for patients in palliative care: managing cancer and living meaningfully (CALM)

Characteristics and Effectiveness of Individual Psychotherapy for Palliative and End-of-Life Care: A Literature Review for Randomized Controlled Trials.

The introduction of psychotherapy in palliative and end-of-life care settings has become increasingly common and is effective in decreasing many psychological problems. This review reports the characteristics and effectiveness of individual psychotherapeutic interventions for patients receiving palliative and end-of-life care. In addition, the review reports the effectiveness of psychotherapies considering the expected life expectancy. The PubMed, Google Scholar, and Cochrane Library databases were searched for English-language articles published between January 2000 to May 2023. Twenty-six studies were included and classified into a total of nine types of psychotherapies, namely, dignity therapy (DT), life review therapy, narrative therapy, managing cancer and living meaningfully (CALM), individual meaning-centered psychotherapy, meaning and purpose therapy, meaning-making therapy, meaning-of-life therapy, and cognitive therapy. Most of the psychotherapies provided to patients receiving palliative and end-of-life care showed effectiveness in the reduction of negative emotions and positive factors related to end-of-life issues. Most studies targeted patients with advanced cancer; however, studies on DT did not limit the target group to patients with cancer. Considering the expected life expectancy, CALM was found to be suitable for patients receiving early palliative care.

Existential Therapy within Palliative Care: Searching for Meaning

IntroductionIrvin D. Yalom defines existential psychotherapy as a dynamic therapeutic approach that focuses on concerns rooted in existence with the four ultimate concerns being death, isolation, meaning in life, and freedom. Patients in advanced stages of cancer often experience elevated levels of psychological distress, encompassing conditions such as depression, anxiety, and a sense of spiritual hopelessness. Recently, interest in spiritual well-being has prompted a new wave of interventions that directly target this population, namely logotherapy and other existential interventions based on existential principles.ObjectivesIn this review, the primary focus was to comprehend the current evidence on the application of existential psychotherapy for individuals coping with advanced cancer and give an overview of the therapy approaches used.MethodsNarrative review of scientific literature using Pubmed search engine.ResultsTerao and Satoh identified nine types of existential psychotherapies which were investigated using randomized controlled trials for patients with advanced cancer or in terminal care: Meaning-Centered Group Psychotherapy (MCGP), Individual Meaning-Centered Psychotherapy (IMCP), Meaning-Making intervention (MMi), Meaning of Life Intervention, Managing Cancer and Living Meaningfully (CALM), Hope Intervention, Cognitive and Existential Intervention, Dignity Therapy, and Life-Review Interviews. All deal with the issues pointed by Yalom. Existential or spiritual well-being improvements were validated in MCGP, IMCP, Meaning of Life intervention, and Life-Review intervention.ConclusionsCurrent evidence is still based on a very limited number of studies. Additional research is needed to delve into the impact of existential psychotherapy on individuals facing advanced cancer.Disclosure of InterestNone Declared

Feasibility of online managing cancer and living meaningfully (CALM) in Chinese patients with metastatic breast cancer: a pilot randomized control trial

Metastatic breast cancer could cause various psychological symptoms. Managing Cancer and Living Meaningfully (CALM) is a brief, manualized psychotherapy that has been validated for advanced cancer patients. We conducted a pilot randomized control trial (RCT) to verify the feasibility and preliminary efficacy of CALM therapy in this population. Patients who met the inclusion criteria were randomly assigned into CALM or Wait-list Control (WLC) groups. Patients in the CALM group received CALM therapy and usual care; patients in WLC group first received usual care and then underwent CALM therapy after completing all assessments. All patients were asked to complete three assessments: T0(baseline), T1(3 months), and T2(6 months). The primary outcomes was death anxiety; other outcomes were depression, distress, suicide ideation, attachment security, spiritual well-being and quality of life at the end of life. Analysis of Covariance (ANCOVA) and t-test were used for statistics analysis. Thirty-six patients were randomly assigned to either of the two groups, with 34 patients completing the three assessments. At six months, we found significant between group differences in suicide ideation, distress, and life completion between the CALM and WLC groups. At T2, patients in CALM group reported lower levels of depression (F = 5.016, p = 0.033, partial η2 = 0.143), distress (F = 7.969, p = 0.010, partial η2 = 0.257), attachment avoidance (F = 4.407, p = 0.044, partial η2 = 0.128), and better sense of life completion (F = 5.493, p = 0.026, partial η2 = 0.155) than patients in the WLC group. Compared with results of the T0 assessments, we found significant differences in socres for depression (T2&T0, t = − 2.689, p = 0.011, Cohen’s d = 0.940) and distress (T2&T0, t = − 2.453, p = 0.022, Cohen’s d = 0.965) between the two groups. CALM therapy was well received by the study population, and CALM therapy can reduce depression, distress, attachment avoidance while improving quality of life in Chinese metastatic breast cancer patients. A Phase III RCT was recommended to verify the impact of CALM therapy on psychological burden and survival in this population.Trial registration: This study is part of the “Preliminary application study for Managing Cancer and Living Meaningfully (CALM) therapy in Chinese advanced cancer patients” clinical trial, with the Trial Registration Number of ChiCTR1900023129 (13/05/2019) in the Chinese Clinical Trial Registry (ChiCTR) website. (https://www.chictr.org.cn/index.html).

Effectiveness of structured psycho-oncological counseling for relatives of lung cancer patients based on the CALM approach—study protocol of a randomized controlled trial

BackgroundThe high incidence combined with the high lethality and bad prognosis of lung cancer highlight the need for psycho-oncological care for both patients and their relatives. While psychological interventions for relatives might be helpful, further research on the impact of specific interventions is necessary. Therefore, this trial aims to evaluate structured psycho-oncological counseling for relatives of lung cancer patients based on the Managing Cancer And Living Meaningfully (CALM) approach compared to usual care. In addition, we explore the impact of psycho-oncological support of relatives on the patients’ mental health outcomes.MethodsThe study is a single-center, prospective, randomized controlled trial with two measurement time points. Relatives of lung cancer patients and, thus, the patients themselves (i.e., dyads) are randomly allocated to the intervention group (IG) or the control group (CG) regardless of their disease or treatment stage. Relatives in the IG receive structured counseling based on the CALM approach (three to six sessions with psycho-oncologists). The CG receives usual psycho-oncological care. In addition, cancer patients in both study arms can request psycho-oncological support (usual care) as needed, but they will not get a specific intervention. Relatives and patients complete assessments at baseline (T0) and after the intervention/6 weeks (T1). The primary outcome for relatives is anxiety. Relatives’ secondary outcomes include depressive symptoms, distress, supportive care needs, and quality of life. Patients’ outcomes include anxiety, depression, and distress. All outcomes are assessed using self-report validated questionnaires. Intervention effects will be evaluated using analysis of covariance (ANCOVA) adjusting for baseline values. Power calculations reveal the need to enroll 200 subjects to detect an effect of d = 0.4.DiscussionThe study will provide evidence for the effectiveness of the CALM intervention in relatives of lung cancer patients. Furthermore, study results will contribute to a better understanding of the effectiveness of a psycho-oncological intervention for highly impaired cancer patients and their relatives. If the CALM intervention positively affects the relatives’ psychosocial outcome, it may be implemented in routine care.Trial registrationGerman Clinical Trials Register DRKS00030077. Retrospectively registered on 26 October 2022.

Managing cancer and living meaningfully (CALM): Implementation in Dutch cancer care.

Managing Cancer and Living Meaningfully (CALM) is a brief, evidence-based psychotherapy tailored for patients with advanced cancer that has not yet been implemented routinely in Dutch cancer care. The aim of this study was to assess the feasibility, acceptability, sustainability and effectiveness of CALM in different clinical settings in the Netherlands. In 2019 and 2020 a multi-center, intervention-only study was performed in three Dutch cancer care settings. Professionals were trained to provide CALM under supervision. Patients diagnosed with advanced cancer were included and filled out questionnaires to measure depression (Patient Health Questionnaire-9), death anxiety (Death and Dying Distress Scale), and anxiety (hospital anxiety and depression scale-anxiety) at baseline, 3 and 6months. The Clinical Evaluation Questionnaire was used to assess acceptability of CALM at 3 and 6months. Sixty-four patients (55% of the eligible patients) were included in the study and 85% of the included patients received 3 or more CALM sessions. Of the 24 trained therapists, 15 (63%) started providing CALM. Two years post-study, CALM was provided in each center by a total of 19 therapists. On average, patients perceived CALM to be at least somewhat helpful. A significant decrease in severity of depression (p=0.006), death anxiety (p=0.008), and anxiety (p=0.024) was observed over time. This study shows that CALM therapy is feasible, acceptable, and sustainable in three Dutch cancer care settings, although not all predefined feasibility criteria for therapists were met. CALM can be effective in decreasing feelings of depression, anxiety, and death anxiety in patients with advanced cancer.

QOL-11. ADAPTING CALM PSYCHOTHERAPY FOR CAREGIVERS OF PATIENTS WITH MALIGNANT GLIOMA

Abstract Caregivers of patients with malignant gliomas (PwMG) report significant emotional distress yet are often omitted from supportive psycho-oncology programs. CALM (Managing Cancer and Living Meaningfully), an evidence-based psychotherapy, has shown preliminarily to reduce depressive and existential distress among PwMG. While caregivers are invited to participate in CALM alongside the patient, the benefit of CALM for caregivers has not yet been evaluated. This NIH ORBIT model phase 1a qualitative study sought to assess caregivers’ interest in CALM and their recommendations to adapt the intervention to their emotional needs. Bereaved caregivers (N = 22, Mage = 47.2, 77% female, 73% White) of PwMG participated in 90-minute focus groups (n = 4-7). Caregivers first received psycho-education on CALM and then participated in a semi-structured group interview. Sessions were audio-recorded, transcribed, and coded by five independent coders using thematic content analysis and NVivo software (kappa = .80-.94). Three major themes were explored: 1) CALM’s relevancy to the neuro-oncology caregiving experience; 2) the suitability of CALM for PwMG caregivers; and 3) suggested adaptations to CALM for PwMG caregivers. First, caregivers felt the four domains of CALM mirrored their experience of caregiving. Secondly, they noted both strengths and weaknesses of the intervention. Lastly, caregivers provided valuable recommendations to improve the timing (e.g., introduce CALM early, continuously), content (e.g., include sessions about bereavement and caregiver burden), and format (e.g., both independent and joint sessions) of the CALM intervention. Examples of each theme will be provided. The results suggest that CALM may be a potentially impactful intervention for the emotional needs of caregivers of PwMG. Nevertheless, adjustments to the timing, content, and format of this intervention are warranted, prior to a future feasibility/acceptability trial. This study not only provides the foundational data required to proceed with future CALM trials, but it also provides valuable considerations for those developing interventions for caregivers of PwMG largely.

QOL-20. INCLUDING BRAIN METASTASES PATIENTS IN PSYCHOLOGICAL INTERVENTIONS: A PHASE II SINGLE-ARM INVESTIGATION OF MANAGING CANCER AND LIVING MEANINGFULLY

Abstract BACKGROUND Patients with brain cancer demonstrate substantial psychological distress yet are frequently excluded from psychological research. Managing Cancer and Living Meaningfully (CALM), an expressive-supportive psychotherapy designed to address the challenges faced by patients with advanced cancer. CALM is proven to reduce depression and death-related distress; however, patients with brain metastases (bMETs) have not been formally examined for CALM’s appropriateness or effectiveness. METHODS In this ongoing Phase II trial, 15 adults with bMETs and heightened distress (PHQ/DADDS) participate in a six-session CALM intervention and complete intervention satisfaction surveys and interviews. Data collection includes established feasibility and acceptability metrics, intervention satisfaction surveys and interviews, and changes in distress patient reported outcomes (pre-to-post CALM). RESULTS Of 21 patients screened, 15 enrolled in the study (73% female; 80% White; Mage = 58yrs). All 15 bMET participants completed baseline assessments, with 13 trial initiators, and 2 screen fails. To date, 8 participants have completed treatment. Reasons for withdrawal include disinterest in intervention topics (n = 1) and lost to follow-up (n = 2). Retention is 73%, with 2 participants still in active treatment. No adverse events were determined to be study-related. Perceived benefit was high (4.3/5), and all participants reported they would recommend the program to others. Reductions in depression severity were demonstrated in 6 of 8 completed participants (MPHQ Reduction = 7.6, range = 2-11) and in death anxiety severity for 7 of 8 completed participants (MDADDS-F1 Reduction = 14.7, range = 6-23). CONCLUSIONS Preliminary data suggests that CALM is both feasible and acceptable among adult patients with bMETs. Enrollment and retention rates are adequate. Patients report high benefit and recommendation to others. Overall, depression and death-related distress severity scores improved, suggesting CALM may be a promising intervention for neuro-oncology patients as they navigate the challenges of metastatic brain cancer. These findings support advancement to the next stage, a Phase II pilot RCT.

QOL-12. NEURO-ONCOLOGY INCLUSION IN PSYCHOTHERAPEUTIC INTERVENTION TRIALS: LEARNING WHICH COGNITIVE ADAPTATIONS COULD SUPPORT PATIENT ENGAGEMENT?

Abstract BACKGROUND Many patients with brain tumors experience double vulnerability—significant emotional distress coupled with cognitive decline—however, these cognitive changes often prohibit their inclusion in psychotherapeutic interventions that might otherwise improve their wellbeing. The primary goal of this analysis was to understand how best to accommodate the neurocognitive needs of patients with brain tumors so that they may effectively participate in future psychotherapeutic interventions. Our secondary goal was to assess potential differences in desired cognitive adaptations between patients with primary compared to metastatic brain tumors. METHODS In two recently completed Phase 2 proof-of-concept trials, patients with both primary and metastatic brain tumors (N = 27) participated in a 3-month psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). During exit interviews, participants reported whether evidence-informed accommodations would support their cognitive limitations and enhance engagement in future trials. Additionally, trial interventionists identified which accommodations were used in each session. RESULTS Participants recommended several accommodations: appointment reminders (100%), topic refreshers (94%), prior session summaries (88%), visual handouts (82%), time for consolidation (71%), transcription notepads (65%), and questionnaire completion assistance (24%). Interventionists documented using appointment reminders (66%), topic refreshers (53%), prior session summaries (60%), and time for consolidation (60%) in more than half of sessions. Visual handouts (2%), notepads (0%), and questionnaire assistance (17%) were rarely or never used. CONCLUSIONS: RESULTS were similar across the two brain tumor populations surveyed: primary and metastatic brain tumors. Accommodations that were recommended by patients and used by interventionists included: (1) appointment reminders to support session attendance, (2) topic refreshers and prior session summaries to support memory, and (3) additional time to assist with slower processing and support comprehension. Implementing supportive cognitive strategies is vital when promoting neuro-oncology inclusion in psychotherapeutic interventions and meeting the needs of this underserved population.

Teaching Oncology Nurses a Psychosocial Intervention for Advanced Cancer: A Mixed-Methods Feasibility Study

ObjectivesPsychological interventions for advanced cancer patients are effective in decreasing distress but are not well integrated into cancer care. Oncology nurses are well positioned to deliver such interventions, and their participation may enhance professional satisfaction and wellbeing. Managing Cancer and Living Meaningfully (CALM) is an evidence-based psychotherapy supporting advanced cancer patients. A CALM-Nurses (CALM-N) training program was developed to teach oncology nurses the basics of CALM for use in daily practice. Feasibility and acceptability of CALM-N and its impact on professional wellbeing were assessed in this pilot study. Data SourcesFifty-five nurses attended CALM-N in three groups. Thirty-five nurses completed the first e-learning, 29 nurses (83%) attended the first group session, and 22 (63%) attended all sessions. At baseline, 35 questionnaires were collected. Response rate at follow-up was 63% for Jefferson Scale of Empathy (n=22), 66% for self-efficacy scale (n=23), and for subscales of Professional Quality of Life Scale burnout; 51% (n=18), secondary traumatic stress; 49% (n=17), compassion satisfaction; 57% (n=20). A statistically significant increase in self-efficacy was found, but there were no significant changes in PROQOL and empathy. Focus groups suggested CALM-N helped nurses’ understanding of patients and nurse–patient communication and increased reflection and perspective taking. ConclusionCALM-N is a feasible and acceptable intervention for oncology nurses, with the potential to improve nurse-patient communication and the nurses’ reflective capacities. Implications for Nursing PracticeCALM-N has the potential to improve the capacity of oncology nurses to provide psychosocial care for advanced cancer patients and its application to nursing practice merits further investigation.

Managing Cancer and Living Meaningfully (CALM) alleviates chemotherapy related cognitive impairment (CRCI) in breast cancer survivors: A pilot study based on resting-state fMRI.

Chemotherapy related cognitive impairment (CRCI) is a type of memory and cognitive impairment induced by chemotherapy and has become a growing clinical problem. Breast cancer survivors (BCs) refer to patients from the moment of breast cancer diagnosis to the end of their lives. Managing Cancer and Living Meaningfully (CALM) is a convenient and easy-to-apply psychological intervention that has been proven to improve quality of life and alleviate CRCI in BCs. However, the underlying neurobiological mechanisms remain unclear. Resting-state functional magnetic resonance imaging (rs-fMRI) has become an effective method for understanding the neurobiological mechanisms of brain networks in CRCI. The fractional amplitude of low-frequency fluctuations (fALFF) and ALFF have often been used in analyzing the power and intensity of spontaneous regional resting state neural activity. The recruited BCs were randomly divided into the CALM group and the care as usual (CAU) group. All BCs were evaluated by the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) before and after CALM or CAU. The rs-fMRI imaging was acquired before and after CALM intervention in CALM group BCs. The BCs were defined as before CALM intervention (BCI) group and after CALM intervention (ACI) group. There were 32 BCs in CALM group and 35 BCs in CAU group completed the overall study. There were significant differences between the BCI group and the ACI group in the FACT-Cog-PCI scores. Compared with the BCI group, the ACI group showed lower fALFF signal in the left medial frontal gyrus and right sub-gyral and higher fALFF in the left occipital_sup and middle occipital gyrus. There was a significant positive correlation between hippocampal ALFF value and FACT-Cog-PCI scores. CALM intervention may have an effective function in alleviating CRCI of BCs. The altered local synchronization and regional brain activity may be correlated with the improved cognitive function of BCs who received the CALM intervention. The ALFF value of hippocampus seems to be an important factor in reflect cognitive function in BCs with CRCI and the neural network mechanism of CALM intervention deserves further exploration to promote its application.

Effects of CALM intervention on neutrophil-to-lymphocyte ratio (NLR), fear of cancer recurrence and quality of life in patients with lung cancer.

To evaluate the feasibility and practicability of Managing Cancer and Living Meaningfully (CALM) as a psychological intervention to reduce neutrophil to lymphocyte ratio (NLR), fear of cancer recurrence, general distress, and improve quality of life in lung cancer survivors. Eighty lung cancer patients with FCRI severity subscale (≥13 points) were recruited and randomly assigned to CALM or usual care (UC). NLR was recorded before and after treatment. The Fear of Cancer Recurrence Inventory (FCRI), Quality of Life Questionnaire Core 30 (QLQ-C30) and Depression-Anxiety-Stress Scale (DASS-21) were used to evaluate patients at baseline (T0), immediately after treatment (T1), and at 2 (T2) and 4 (T3) months. Compared with UC, NLR was significantly different before and after CALM intervention (z=-5.498; P=0.000). There were significant differences in the scores of QLQ, FCR and general distress before and after the T1, T2 and T3 interventions (F=220.30, F=315.20, F=290.10, respectively; P<0.001). NLR was negatively correlated with QOL both before (r=-0.763; P<0.0001) and after the intervention (r=-0.810, P<0.0001). FCR and general distress were negatively correlated with QOL in CALM (T0: r=-0.726, r=-0.776, respectively; P<0.0001; T1: r=-0.664, r=-0.647, respectively; P<0.0001; T2: r=-0.678, r=-0.695, respectively; P<0.0001; T3: r=-0.511, P = 0.0008; r=-0.650, P<0.0001). CALM intervention can effectively reduce the NLR, alleviate the recurrence fear and general distress and improve the quality of life in patients. This study suggests that CALM may be an effective psychological intervention for reducing symptoms associated with lung cancer survivors.

Evaluation of Managing Cancer and Living Meaningfully (CALM) in people with advanced non-small cell lung cancer treated with immunotherapies or targeted therapies: protocol for a single-arm, mixed-methods pilot study

IntroductionPeople with advanced non-small cell lung cancer (NSCLC) treated with immunotherapies (IT) or targeted therapies (TT) may have improved outcomes in a subset of people who respond, raising unique psychological...

The effects of Managing Cancer and Living Meaningfully (CALM) on psychological distress in esophageal cancer patients.

Aim: To evaluate the effectiveness of Managing Cancer and Living Meaningfully (CALM) in esophageal cancer with psychological distress during treatment. Materials & methods: The study assigned eligible patients to either a CALM group or a usual care group. Psychological distress, anxiety, depression and quality of life scores were assessed for both groups at baseline, during the intervention period and at the end of the intervention. Results: Patients showed a significant reduction in psychological distress, anxiety and depression and demonstrated improved quality of life after the CALM intervention, and the positive effect remained after 1month of follow-up. Conclusion: This study suggests that CALM may be an effective approach for targeting psychological distress in patients with esophageal cancer.

Impact of the CALM intervention on breast cancer patients during the COVID-19 pandemic.

The COVID-19 outbreak has adversely affected breast cancer patients both physically and mentally. Managing Cancer and Living Meaningfully (CALM) is a psychological intervention that is easy to implement. It also decreases the possibility of virus transmission because it can be administered online. Therefore, this study investigated the effects of CALM on the sleep quality, memory, psychological distress, and quality of life (QoL) of breast cancer patients during the ongoing COVID-19 pandemic. Sixty breast cancer patients were recruited and randomly assigned to a CALM group and a Care as Usual (CAU) group. They filled in questionnaires before and after the CALM intervention and CAU. These included the Sleep Quality Scale (SQS), Prospective Memory Scale (PM), Retrospective Memory Scale (RM), Psychological Distress Thermometer (DT), and Quality of life (QoL) Scale. The scores of all the aforementioned scales after the CALM intervention (ACM) were significantly lower compared to the said scores before the CALM intervention (BCM) and after Care as Usual (ACU) (t = 12.369/8.013, t = 8.632/4.583, t = 7.500/6.900, t = 12.479/9.780, t = 12.224/6.729 respectively, P < 0.05) There was a linear correlation between the QoL, DT, and SQS scores. CALM is an effective psychotherapy for breast cancer patients, especially during the COVID-19 pandemic, for improving the QoL because it relieves psychological distress and enhances sleep quality.

Editorial introductions.

Editorial introductions.

A gender-sensitive analysis of the feasibility and benefit of a psychological intervention for patients with advanced cancer

Background: The role of gender in psychotherapy has been widely recognized but infrequently investigated in psychotherapy trials. We conducted a secondary analysis of data from a randomized controlled trial of Managing Cancer and Living Meaningfully (CALM), a supportive-expressive intervention for individuals with advanced cancer, to examine gender effects in the feasibility, acceptability, perceived benefit, and effectiveness of CALM. Methods: Trial participants, outpatients with advanced cancer (N = 305, 40% men and 60% women), completed measures at baseline, 3 months (t1), and 6 months (t2). We investigated gender differences in participation rates, attrition rates, number of CALM sessions received, and perceived benefit of CALM. Separate subgroup analyses of data and gender × treatment group moderator analyses from men and women were compared in examining treatment effects on depressive symptoms, end-of-life preparation, and death anxiety at each follow-up period. Results: No gender differences were observed in participation or attrition rates, number of CALM sessions received, or perceived benefit of CALM. In subgroup analyses at t2, men in CALM reported significantly lower depressive symptoms than men in usual care (UC; P = .017), women in CALM with moderate baseline death anxiety reported lower death anxiety than women in UC (P = .009), and both men (P = .022) and women (P = .016) in CALM reported greater end-of-life preparation than those in UC. There were no significant gender × treatment group interaction effects on any outcome. Conclusions: CALM therapy is feasible, acceptable, and beneficial on different outcomes for men and women. Further clinical trials with comprehensive measures of gender identity are needed to evaluate gender effects in psychotherapeutic interventions for patients with advanced disease.

Brief, manualised and semistructured individual psychotherapy programme for patients with advanced cancer in Japan: study protocol for Managing Cancer and Living Meaningfully (CALM) phase 2 trial

IntroductionManaging Cancer and Living Meaningfully (CALM) is a novel, brief and manualised psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced cancer. This phase...