Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial.

Importance: The unmet needs regarding symptom management of psychological distress among patients with breast cancer must be addressed. However, little evidence exists on effective interventions, such as nurse navigation. Objective: To compare the long-term effects of the REBECCA (Rehabilitation After Breast Cancer) nurse navigation intervention vs usual care in patients with breast cancer who were psychologically vulnerable. Design, Setting, and Participants: This parallel randomized clinical trial recruited and evaluated for eligibility adult female patients with newly diagnosed breast cancer and symptoms of psychological distress (distress score of ≥7 points on Distress Thermometer) at Rigshospitalet in Copenhagen, Denmark, from August 2017 to October 2019. This study continued the work of a pilot study, extending the follow-up to 18 months. Patients who met the inclusion criteria were randomized to either standard care or the REBECCA intervention. Intention-to-treat analyses were performed from June 2021 to October 2022. Interventions: Patients who were randomized to the REBECCA intervention received nurse navigation and symptom screening as well as standard care. Standard care included regular treatment, nurse support at chemotherapy and radiotherapy appointments, and municipality-based rehabilitation. Main Outcomes and Measures: The primary outcome was distress, as measured using the Distress Thermometer. The secondary outcomes included symptoms of anxiety, symptoms of depression, breast cancer-specific health-related quality of life, fear of recurrence, sleep, cognitive function, patient activation, pain, health behavior, body mass index, and need for support. Long-term effects at 6, 12, and 18 months were examined using mixed-effect models, adjusting for randomization strata of age and treatment modality. Results: A total of 309 female patients were included in the analysis, with 153 patients randomized to the standard care group and 156 patients randomized to the REBECCA intervention group. Mean (SD) age was 56 (11) years with only small between-group differences. Patients receiving the REBECCA intervention compared with standard care had reduced (although not significant) symptoms of distress, especially at the 12-month follow-up (estimated effect = -0.51 [95% CI, -1.05 to 0.04]; effect size [ES] = -0.49). Significant effects were seen for symptoms of depression at 6 months (estimated effect = -1.39 [95% CI, -2.33 to -0.44]; ES = -0.27), and breast cancer-specific health-related quality of life at 12 months (estimated effect = 4.03 [95% CI, 1.28- 6.77]; ES = 0.31). Nonsignificant reductions were seen for symptoms of anxiety at 6 months (estimated effect = -1.00 [95% CI, -1.95 to -0.06]; ES = -0.21) and 12 months (estimated effect = -1.01 [95% CI, -1.97 to -0.04]; ES = -0.21), and a nonsignificant increase was seen for patient activation at 18 months (estimated effect = 3.52 [95% CI, -0.09 to 7.12]; ES = 0.25). Stronger intervention effects were observed for younger age, low patient activation, less education, and low social support. Conclusions and Relevance: Results of this study indicate that patients with breast cancer who were psychologically vulnerable (ie, having moderate to high psychological distress) did not experience significant reduction in distress with nurse navigation. Further research is needed to develop the intervention's framework and investigate its potential use in clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT03254875.

[Ductal carcinoma in situ].

Ductal carcinoma in situ (DCIS) is a premalignant lesion in the breast. It is often asymptomatic and diagnosed by screening mammography. DCIS is treated in line with low-risk invasive breast cancer including mastectomy or breast-conserving treatment plus radiotherapy, implicating a risk of both physical and psychological side effects. Since only a part of DCIS lesions develop into invasive cancer, some women suffer from overtreatment. However, it remains yet to be identified, in which subgroup of women with DCIS treatment can safely be omitted. We need to know more about the natural course of DCIS and develop tools to tailor treatment individually.

The effects of individually tailored nurse navigation for patients with newly diagnosed breast cancer: a randomized pilot study.

AIM: Our aim was to determine the feasibility and effectiveness of an individual, nurse-navigator intervention for relieving distress, anxiety, depression and health-related quality of life in women who have been treated for breast cancer (BC) and are experiencing moderate-to-severe psychological and physical symptoms. METHODS: Fifty women with newly diagnosed BC who reported distress (score ≥7 on distress thermometer) before surgery were included consecutively in a pilot study and randomized 1:1 to the intervention or the control group. The intervention comprised repeated screening with patient reported outcome measures and nurse navigation. A total of 66 women who were not distressed (score <7) were followed longitudinally as an observational group. Participants filled in four questionnaires, at baseline, after 6 months and 12 months. The primary outcome was psychological distress and the secondary outcomes were anxiety, depression, health-related quality of life and feasibility of the intervention. RESULTS: Women in the intervention group reported significantly greater satisfaction with treatment and rehabilitation and lower levels of distress (mean 2.7 vs. 5.1, p<.01), anxiety (mean 5.1 vs. 7.8, p = .02) and depression (mean 2.2 vs. 4.4, p = .04) after 12 months compared to the control group. No significant effects were seen on health-related quality of life. CONCLUSIONS: The study shows promising feasibility of the individually tailored nurse-navigation intervention and while no significant effects were observed after 6 months, we did find statistically significant effects on distress, anxiety and depression 12 months after diagnosis. Our results will assist in developing rehabilitation to the most vulnerable patients.

Pain, Sensory Disturbances, and Psychological Distress among Danish Women Treated for Ductal Carcinoma In Situ: An Exploratory Study.

Ductal carcinoma in situ is a noninvasive precancer condition. The treatment resembles the treatment of invasive breast cancer. The aim of this exploratory study was to gain knowledge on the level of postoperative pain, sensory disturbances, and distress among a small group of Danish women with ductal carcinoma in situ who had sentinel lymph node biopsy in order to plan a population study. A subgroup of patients with ductal carcinoma in situ (n = 20) was compared to patients with invasive breast cancer (n = 455) at time of diagnosis and after 12 months. Six patients were interviewed on the impact of the diagnosis and life after treatment. We found no significant difference in reported sensory disturbances or pain after 12 months between the groups. More than one-third (39%) of ductal carcinoma in situ patients reported moderate to severe distress (≥ 7 on the Distress Thermometer) at time of diagnosis decreasing to 10% after 12 months. Similarly 36% of breast cancer patients reported distress at time of diagnosis and 10% after 12 months. Interviews confirmed that ductal carcinoma in situ patients experienced distress and also uncovered physical problems and rehabilitation needs. The study indicates that women with ductal carcinoma in situ seem to suffer from pain and distress. The study highlights the need for a large study in order to validate the findings. Additional efforts may be needed to improve patients' understanding of diagnosis of ductal carcinoma in situ and alleviate psychological morbidity and physical restraints related to the condition.

Pain, sensory disturbances and psychological distress are common sequelae after treatment of ductal carcinoma in situ: a cross-sectional study.

Sequelae such as pain, sensory disturbances and psychological distress are well known after treatment for invasive breast cancer (IBC). Patients treated for ductal carcinoma in situ (DCIS) receive a similar treatment as low-risk IBC. The aim of this cross-sectional study was to describe prevalence of postoperative pain, sensory disturbances, psychological distress and rehabilitation needs among Danish women with DCIS. METHODS: A total of 574 women treated for DCIS in Denmark in 2013 and 2014 were enrolled and 473 (82%) completed a detailed questionnaire on demographic factors, pain, sensory disturbances, psychological aspects and rehabilitation needs 1-3 years after surgery. RESULTS: Median age was 60 years. A total of 33% of patients reported any pain and 12% reported moderate to severe pain in the area of surgery. Younger age (<50 years OR 4.7 (95% CI: 1.6-14.0, p = 0.006)), aged 50 to 65 years OR 2.8 (95% CI: 1.1-7.0, p = 0.02) and anxiety and depression (measured by HADStotal >15 OR of 3.1 (95% CI: 1.5-6.3, p = 0.003)) were significantly associated with moderate to severe pain. Approximately one-third of the patients reported sensory disturbances such as pins and needles (32%), numbness (37%) and painful itch (30%) and 94 women (20%) reported anxiety ≥8, 26 (6%) depression and 51 (11%) reported distress. CONCLUSIONS: This cross-sectional study showed that women treated for DCIS suffered from pain, sensory disturbances and psychological impairment and had unmet rehabilitation needs. Further research is warranted, specifically addressing rehabilitation after diagnosis and treatment of DCIS.

Preoperative Distress Predicts Persistent Pain After Breast Cancer Treatment: A Prospective Cohort Study.

PURPOSE: Persistent pain after breast cancer treatment (PPBCT) affects 25% to 60% of breast cancer survivors and is recognized as a clinical problem, with 10% to 15% reporting moderate to severe pain several years after treatment. Psychological comorbidity is known to influence pain perception, and evidence links signs of depression and anxiety with development of PPBCT. The purpose of this study was to assess preoperative distress as a predictive factor for development of PPBCT. METHODS: Between October 2008 and October 2009, 426 women diagnosed with primary breast cancer, undergoing surgery at the Department of Breast Surgery, Rigshospitalet, Denmark, were invited to participate in the study. Patients filled out a questionnaire preoperatively, and 4 and 8 months after surgery. Preoperative distress was measured with the Distress Thermometer (DT; 11-point scale, 0-10). We examined the association between severe preoperative distress (using DT ≥7) and moderate to severe PPBCT 8 months after diagnosis using a logistic regression model. RESULTS: A total of 357 patients participated in this study and 291 (82%) returned all follow-up questionnaires. Preoperative distress was significantly associated with moderate to severe PPBCT at 8 months, with an adjusted odds ratio (OR) of 2.05 (95% CI, 1.18-3.59; P=.01), and at 4 months, with an OR of 2.23 (95% CI, 1.23-4.05; P=.01). CONCLUSIONS: Preoperative distress was associated with PPCBT, suggesting distress as an independent risk factor for PPBCT. Preoperative identification of patients at risk for PPBCT allows for further research in psychological and pharmacological treatment of this condition.

Fatigue trajectories during the first 8 months after breast cancer diagnosis.

PURPOSE: The objective of this study was to identify distinct groups of fatigue trajectories among women with breast cancer and to evaluate whether age, anxiety symptoms, physical activity, and type of treatment were associated with belonging to the most adverse fatigue group. METHODS: Women scheduled for breast cancer surgery at Copenhagen University Hospital, Denmark, were consecutively invited to participate in the study (n = 424), resulting in 290 women included in the analyses. Semiparametric group-based mixture modeling was used to identify distinct trajectories of fatigue assessed the week before surgery and 4 and 8 months later. Logistic regression analysis was used to evaluate differences in the distinct fatigue groups. RESULTS: Two distinct groups of fatigue trajectories were identified. One group (21 %) had a high mean level, while the second group (79 %) had a low mean level of fatigue throughout the study. In multivariate analyses, sedentary physical activity (OR 5.78; 95 % CI 1.41-23.75), low physical activity (OR 3.17; 95 % CI 1.15-8.74), and increasing anxiety symptoms (OR 1.23; 95 % CI 1.14-1.33) before surgery were significantly associated with being in the high-fatigue group. CONCLUSIONS: The results show that one-fifth of women with breast cancer experience continuously high fatigue up to 8 months after surgery and may have been more anxious and physically inactive. This knowledge is important in targeting interventions to women with fatigue throughout their treatment and who do not return to a low fatigue level with existing treatment, self-management, or support.

Trajectories of distress, anxiety, and depression among women with breast cancer: Looking beyond the mean.

OBJECTIVE: Little is known about the development of psychological wellbeing over time among women who have been treated for breast cancer. The aim of this study was to identify distinct patterns of distress, anxiety, and depression in such women. METHODS: We invited 426 consecutive women with newly diagnosed primary breast cancer to participate in this study, and 323 (76%) provided information on distress ('distress thermometer') and on symptoms of anxiety and depression ('hospital anxiety and depression scale'). Semiparametric group-based mixture modeling was used to identify distinct trajectories of distress, anxiety, and depressive symptoms assessed the week before surgery and four and eight months later. Logistic regression analysis was used to evaluate the characteristics of women in the distinct groups. RESULTS: Although no sub-group of women with chronic severe anxiety or depressive symptoms was found, we did identify a sub-group of 8% of the women who experienced continuously severe distress. Young age, having a partner, shorter education, and receiving chemotherapy but not radiotherapy might characterize women whose psychological symptoms remain strong eight months after diagnosis. CONCLUSION: By looking beyond the mean, we found that 8% of the women experienced chronic severe distress; no sub-groups with chronic severe anxiety or depression were identified. Several socio-demographic and treatment factors characterized the women whose distress level remained severe eight months after diagnosis. The results suggest that support could be focused on relatively small groups of patients most in need.

Fast-track surgery for breast cancer is possible.

INTRODUCTION: Breast cancer is common among Danish women with more than 4,100 new cases annually. In 2008 the concept of fast-track surgery was introduced at the Department of Breast Surgery at Rigshospitalet, Copenhagen. The aim of this study is to describe the new clinical pathway for breast cancer patients after implementation of a fast-track surgery programme. MATERIAL AND METHODS: A clinical pathway of all involved disciplines was developed including anaesthetic, analgesics, nausea and vomiting, drain and wound management, discharge assessment and psychosocial support. RESULTS: The overall mean length of stay (LOS) decreased from 3.6 days before introduction of fast-track surgery to 1.2 days after its implementation. The largest decrease was observed among patients undergoing mastectomy, where LOS was reduced from 5.0 to 1.6 days. The number of beds at the department was reduced by about 30% and a nurse-led clinic was established which enabled nurses to take charge of wound management, seromas, temporary breast prostheses and psychosocial and rehabilitation aspects in the outpatient clinic. Additionally, the previously available telephone counselling service was intensified to provide immediate advice and support. CONCLUSION: The results confirm that a short stay can be successfully carried out for breast cancer patients. Implementing the fast-track programme involved the introduction of a clear clinical pathway for the patients and more effective daily routines. Patients felt safe and confident after early discharge. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Unmet needs of women with breast cancer during and after primary treatment: a prospective study in Denmark.

UNLABELLED: Integrated plans will be required to ensure care and rehabilitation for the growing number of cancer survivors. Information is lacking, however, about the extent to which patients' rehabilitation needs are being met, and characteristics of patients who experience unmet needs after their diagnosis and throughout the disease trajectory. MATERIAL AND METHODS: Consecutive women with newly diagnosed breast cancer, undergoing surgery at the Breast Surgery Clinic, Rigshospitalet, Denmark, between 2008 and 2009 (N = 261), completed questionnaires on their unmet needs, anxiety, physical functioning, social support and demographic factors at the time of surgery and four and eight months after diagnosis. Associations between demographic and clinical factors at baseline and unmet needs four and eight months after diagnosis were examined in logistic regression models. RESULTS: The percentage of women with unmet needs remained stable between four (42%) and eight months (40%). Unmet needs were reported for patient education, counselling and alternative treatment. The factors significantly associated with having unmet needs were younger age (OR 0.92; 95% CI 0.89-0.95), higher education (OR 2.49; 95% CI 1.14-5.44), not having a partner (OR 2.25; 95% CI 1.22-4.17) and anxiety (OR 1.13; 95% CI 1.05-1.20) at four months; and age (OR 0.91; 95% CI 0.87-0.94), not having a partner (OR 2.21; 95% CI 1.10-4.46) and having had one or more unmet needs at four months (OR 6.83, 95% CI 3.55-13.16) at eight months. CONCLUSION: A total of 53% of women with breast cancer had unmet needs at some time between diagnosis and the end of primary treatment (eight months after diagnosis). A contextual understanding of unmet needs is necessary for planning cancer rehabilitation, as not only factors such as anxiety, physical functioning and previous unmet needs but also age, education and relationship status are associated with unmet needs.

Psychological distress among women with newly diagnosed breast cancer.

PURPOSE: Psychological distress is common in the cancer continuum. Our objectives were to determine the prevalence of distress and to investigate the related problems and the characteristics of women with breast cancer who experienced psychological distress at the time of diagnosis. METHODS: We used cross-sectional data from a questionnaire study. Women with newly diagnosed breast cancer were consecutively invited to respond before breast surgery. Between October 2008 and October 2009, a total of 357 responded out of 426 (84%) invited. Among these, 343 patients completed the 'distress thermometer' to measure psychological distress and the accompanying 'problem list' to identify related problems. Logistic regression models with 95% confidence intervals were used to estimate the associations between psychological distress, age, social support and domains on the problem list. RESULTS: With a cut-off of 3 on the distress thermometer, 77% of women with breast cancer reported distress, whereas when the cut-off was 7, 43% were distressed. The mean distress score was 5.4 (SD, 3.1). The most frequently reported problems were worry (77%) and nervousness (71%). Distress was significantly associated with the total score and three domains on the problem list. Younger women (<50 years) reported higher levels of distress than older (≥ 50 years). We found no significant association between distress and having a partner or someone outside the family to rely on. CONCLUSIONS: Distress was reported by 77% of patients. Age and problem list were significantly associated with distress. No significant association between psychological distress and social support was observed.

Accuracy of the Danish version of the 'distress thermometer'.

OBJECTIVE: Short screening instruments have been suggested to improve the detection of psychological symptoms. We examined the accuracy of the Danish version of the 'Distress Thermometer'. METHODS: Between October 2008 and October 2009, 426 women with newly diagnosed primary breast cancer who were operated at the Breast Surgery Clinic of the Rigshospitalet, Copenhagen, were eligible for this study. Of these, 357 participated (84%) and 333 completed a questionnaire. The distress thermometer was evaluated against the 'hospital anxiety and depression scale' (HADS). We also examined the women's wish for referral for psychological support. RESULTS: A cut-off score of 6 vs 7 (low: ≤6, high: ≥7) on the distress thermometer was optimal for confirming distress, with a sensitivity of 42%, a specificity of 93%, a positive predictive value (PPV) of 78% and a negative predictive value (NPV) of 73%. A cut-off score of 2 vs 3 was optimal for screening, with a sensitivity of 99%, a specificity of 36%, a PPV of 47% and a NPV of 99%. Of those who were distressed using the cut-off score of 2 vs 3 on the distress thermometer, 17% (n = 41) wished to be referred for psychological support and 57% (n = 140) potentially wanted a later referral. CONCLUSION: The distress thermometer performed satisfactorily relative to the HADS in detecting distress in our study. A screening procedure in which application of the distress thermometer is a first step could be useful for identifying persons in need of support.