Feasibility and efficacy of 'Can-Sleep': effects of a stepped-care approach to cognitive-behavioral therapy for insomnia in cancer.

PURPOSE: This study aimed to evaluate the feasibility and clinical efficacy of the Can-Sleep stepped-care intervention for people with cancer-related sleep disturbance. METHODS: A total of 147 individuals with cancer were screened. Participants who reported sleep disturbances and were at low-moderate risk for intrinsic sleep abnormalities were given self-managed cognitive behavioral therapy for insomnia (SMCBT-I). Those reporting sleep disturbance and scoring at high risk of intrinsic sleep abnormalities (i.e., restless leg syndrome and obstructive sleep apnoea) were referred to a specialist sleep clinic. In both groups, participants received a stepped-up group CBT-I intervention (GCBT-I) if they continued to report sleep disturbance following SMCBT-I or the specialist sleep clinic. RESULTS: Overall, 87 participants reported sleep disturbance or screened at risk for intrinsic sleep abnormality. Thirty-four were referred to a specialist sleep clinic, and of the 17 who declined this referral, 14 were rereferred to SMCBT-I. In total, 62 participants were referred to SMCBT-I, and 56 commenced SMCBT-I. At post-intervention, the SMCBT-I group showed a significant decline in insomnia symptoms (p < .001, d = 1.01). Five participants who reported sleep disturbance after SMCBT-I and/or the specialist sleep clinic, accepted GCBT-I. Those who received the GCBT-I showed a significant reduction in insomnia symptoms (p < .01, d = 3.13). CONCLUSIONS: This study demonstrates the feasibility and efficacy of a stepped-care intervention for sleep disturbances in people with cancer. IMPLICATIONS FOR CANCER SURVIVORS: A stepped-care intervention for sleep disturbance is a feasible and potentially effective method of addressing a significant and unmet patient need.

Mechanisms of Cognitive Behavioral Therapy and Light Therapy for Cancer-Related Insomnia: A Randomized Clinical Trial during Chemotherapy for Breast Cancer.

STUDY OBJECTIVES: This study aimed to investigate the mechanisms of a combined brief cognitive behavioral plus bright light therapy (CBT-I+Light) in women receiving chemotherapy. METHODS: Women (N = 101) were randomly assigned to CBT-I+Light or treatment as usual plus relaxation audios (TAU+). Participants completed sleep diaries and wore an actigraph during the 6-week intervention period. Patient-reported outcomes were assessed at baseline, mid-point (week 3), and later (week 6). Cognitive (i.e., dysfunctional sleep beliefs, pre-sleep cognitions, and arousal) and behavioral (i.e., time in bed awake and day-to-day out-of-bedtime variability) mechanisms were examined. RESULTS: Cognitively, both groups declined significantly in overall dysfunctional sleep beliefs from pre- to post-intervention (both p< .04); however, they did not differ on sleep-related beliefs nor pre-sleep cognitions and arousal at post-intervention (both p> .50). Dysfunctional beliefs sleep expectations subscale was lower in CBT-I+Light versus TAU+ (p= .01). Behaviorally, CBT-I+Light reported less overall time in bed awake after the start of the intervention (p< .05) and significantly less time in bed during the morning until the final week of the intervention period. Out-of-bedtime day-to-day variability was lower in the CBT-+Light vs TAU+ at the final intervention day. CONCLUSION: Mechanisms of CBT-I+Light during chemotherapy remain to be shown. Our results suggest that changes in behavioral mechanisms may be associated with sleep improvements within this cohort. Future studies should assess the role of additional mechanisms (e.g., sleep effort) within larger samples. Whilst intervention brevity is important, more potent interventions may be required to achieve robust changes in target mechanisms.

The Sleep, Cancer and Rest (SleepCaRe) Trial: Rationale and design of a randomized, controlled trial of cognitive behavioral and bright light therapy for insomnia and fatigue in women with breast cancer receiving chemotherapy.

BACKGROUND: Insomnia and fatigue symptoms are common in breast cancer. Active cancer treatment, such as chemotherapy, appears to be particularly disruptive to sleep. Yet, sleep complaints often go unrecognised and under treated within routine cancer care. The abbreviated delivery of cognitive behavioral therapy for Insomnia (CBTI) and bright light therapy (BLT) may offer accessible and cost-effective sleep treatments in women receiving chemotherapy for breast cancer. METHODS: The Sleep, Cancer and Rest (SleepCaRe) Trial is a 6-month multicentre, randomized, controlled, 2 × 2 factorial, superiority, parallel group trial. Women receiving cytotoxic chemotherapy for breast cancer at tertiary Australian hospitals will be randomly assigned 1:1:1:1 to one of four, non-pharmacological sleep interventions: (a) Sleep Hygiene and Education (SHE); (b) CBTI; (c) BLT; (d) CBT-I + BLT combined and simultaneously delivered. Each sleep intervention is delivered over 6 weeks, and will comprise an introductory session, a mid-point phone call, and regular emails. The primary (insomnia, fatigue) and secondary (health-related quality of life, rest activity rhythms, sleep-related impairment) outcomes will be assessed via online questionnaires at five time-points: baseline (t0, prior to intervention), mid-point intervention (t2, Week 4), post-intervention (t3, Week 7), 3-months (t4, Week 18), and 6-months follow-up (t5, Week 30). CONCLUSIONS: This study will report novel data concerning the comparative and combined efficacy of CBT-I and BLT during chemotherapy. Findings will contribute to the development of evidence-based early sleep and fatigue intervention during chemotherapy for breast cancer. Clinical trial information Registered with the Australian New Zealand Clinical Trials Registry (http://anzctr.org.au/), Registration Number: ACTRN12620001133921.

Light enhanced cognitive behavioral therapy for insomnia and fatigue during chemotherapy for breast cancer: a randomized controlled trial.

STUDY OBJECTIVES: Sleep problems are common during chemotherapy for breast cancer (BC). We evaluated whether combined brief cognitive behavioral and bright light therapy (CBT-I + Light) is superior to treatment as usual with relaxation audio (TAU+) for insomnia symptoms and sleep efficiency (primary outcomes). METHODS: We randomized women receiving intravenous chemotherapy, stratified by tumor stage and insomnia severity index, to 6-week CBT-I + Light or TAU+. CBT-I + Light included 1 in-person session, 1 telephone call, 7 emails, and 20 min bright light (BL) each morning. TAU+ comprised usual treatment and two emails with relaxation audio tracks. Patient-reported outcomes were assessed at baseline, midpoint (week 3), post (week 6), and 3-month follow-up. RESULTS: Women (N = 101) were randomly assigned to CBT-I + Light or TAU+. The CBT-I + Light group showed significantly greater improvement in insomnia symptoms than the TAU+ group (-5.06 vs -1.93, p = .009; between-group effect size [ES] = .69). At 3-month follow-up, both groups were lower than baseline but did not differ from each other (between-group ES = .18, p = .56). CBT-I + Light had higher patient-reported sleep efficiency than TAU+ immediately after the start of intervention (p = .05) and significantly greater improvement in fatigue (between-group ES = .59, p = .013) and daytime sleep-related impairment (between-group ES = .61, p = .009) than the TAU+ group. CONCLUSIONS: CBT-I + Light had a clinically significant impact on insomnia and fatigue with moderate ESs. Results support offering cognitive behavioral therapy for insomnia and BL therapy during chemotherapy for BC to help manage sleep and fatigue. CLINICAL TRIAL: Australian New Zealand Clinical Trials Registry (http://anzctr.org.au/). Registration number: ACTRN12618001255279.

Insomnia and Fatigue Symptom Trajectories in Breast Cancer: A Longitudinal Cohort Study.

Objective: Insomnia and fatigue are common, although not inevitable, during breast cancer. This study is one of the first aiming to describe distinct trajectory classes of insomnia and fatigue symptoms, and their correlates, from diagnosis through treatment.Methods: This longitudinal cohort study was conducted at a comprehensive cancer center and community oncology practices. Participants (N = 460) were women diagnosed with any stage of breast cancer in the previous 4 months. Primary outcomes for this ancillary study of the existing cohort were self-reported insomnia and fatigue symptoms assessed repeatedly across 12 months.Results: Four distinct classes of insomnia symptoms emerged: persistently very high, clinically elevated symptoms (13.7%); high, clinically elevated symptoms (65.9%); stable low (17.2%) or very low (2.6%) symptoms. Five fatigue symptom classes included high, increasing fatigue (9.6%), two recovery classes starting at high (26.3%), or moderate (18.0%) severity at diagnosis, stable low (33.3%) or very low (12.2%) classes. In multivariate analyses, higher depressive symptoms, anxiety, and chronic life stress were associated with being in the very high insomnia class versus the low symptom class. Oncologic factors were not associated with insomnia class membership. Receiving chemotherapy was linked significantly to high and recovery fatigue symptom classes versus the low class. Higher chronic life stress was associated with more persistent fatigue symptoms.Conclusions: Distinct classes of insomnia and fatigue symptoms were evident; 79.6% of the women had clinically elevated, persistent insomnia symptoms, 53.9% had elevated fatigue. A substantial minority evidenced low symptoms, suggesting targeted or stepped-care approaches to symptom management.

Feasibility and Acceptability of Fear-Less: A Stepped-Care Program to Manage Fear of Cancer Recurrence in People with Metastatic Melanoma.

Immunotherapies and targeted therapies have revolutionised treatment of metastatic melanoma and improved survival rates. However, survivors treated with novel therapies are vulnerable to high levels of fear of cancer recurrence or progression (FCR). Existing FCR interventions have rarely been trialled in people with advanced cancer. The current study aimed to evaluate the acceptability and feasibility of Fear-Less: a stepped-care model to treat FCR in people with metastatic melanoma treated with immunotherapy or targeted therapy. Sixty-one outpatients with metastatic melanoma were screened using the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) and Fear of Progression Questionnaire Short Form (FoP-Q-SF). Survivors with subthreshold FCR were stratified to a self-management intervention while those with clinical levels of FCR were provided with an individual therapy, Conquer Fear. Survivor experience surveys and rescreening were administered post-intervention completion. Results indicated that Fear-Less was an acceptable and feasible FCR intervention. Results provided preliminary support for the potential impact of Fear-Less in reducing FCR. Fear-Less is a promising first step in providing an acceptable and feasible stepped-care model to treat FCR in survivors with metastatic disease.

Light-enhanced cognitive behavioural therapy for sleep and fatigue: study protocol for a randomised controlled trial during chemotherapy for breast cancer.

BACKGROUND: Women with breast cancer experience a significantly higher prevalence of sleep disturbance and insomnia than the general population. The experience of persistent sleep disturbance places these women at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment for sleep in this population is not part of routine care and is often managed inadequately. This randomised controlled trial will examine the combined effects of cognitive behavioural therapy (CBT) and bright light therapy (BLT) on the symptoms of insomnia, fatigue and mental health. METHOD/DESIGN: Women diagnosed with breast cancer who receive intravenous chemotherapy treatment at a quaternary referral metropolitan cancer centre in Melbourne, Australia, will be recruited. Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible women will be randomised to the combined CBT and BLT intervention (CBT+) or relaxation audio-enhanced treatment as usual (TAU+). The CBT+ group will receive one face-to-face session on sleep strategies, one subsequent telephone call, and seven email packages containing CBT-based information and strategies. CBT+ participants will also wear Luminette® light glasses for 20 min each morning for the 6-week duration of the intervention. Women in TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the 6 weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT, and sleep-related complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). Data will also be collected on potential treatment moderators and mechanisms and adherence to treatment. There will be 3-month follow-up measurements of insomnia symptoms, fatigue, sleep-related impairment, sleep disturbance, depression and anxiety. DISCUSSION: This is the first randomised controlled trial to combine CBT and BLT for the treatment of sleep disturbance in women with breast cancer. This novel design addresses the multiple causal factors for sleep complaints in this population. Results from this trial will advance knowledge in this field and may have important clinical implications for how best to treat sleep disturbance and insomnia in this population. If effective, the largely email-based format of the intervention would allow for relatively easy translation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12618001255279. Retrospectively registered on 25 July 2018.

Effectively discussing complementary and alternative medicine in a conventional oncology setting: communication recommendations for clinicians.

OBJECTIVE: Justifiable concerns around the use of complementary and alternative medicines (CAM) amongst cancer patients are becoming increasingly prominent. The aim was to develop evidence-based guidelines to assist oncology health professionals (HP) to have respectful, balanced and useful discussions with patients about CAM. METHODS: A systematic review was conducted, covering relevant literature from 1997 to 2007. The level of evidence was rated using a standardized rating system. The evidence was qualitatively synthesised into structured recommendations by a multidisciplinary team including a consumer. RESULTS: The search identified 78 original papers; 36 directly related to discussing CAM. No randomized controlled trials specifically addressing the methods or benefits of discussing CAM were identified. Evidence based guidelines are presented as a sequence of recommended steps: (1) Elicit the person's understanding of their situation; (2) Respect cultural and linguistic diversity and different epistemological frameworks; (3) Ask questions about CAM use at critical points in the illness trajectory; (4) Explore details and actively listen; (5) Respond to the person's emotional state; (6) Discuss relevant concerns while respecting the person's beliefs; (7) Provide balanced, evidence-based advice; (8) Summarize discussions; (9) Document the discussion; (10) Monitor and follow-up. CONCLUSION: This represents the first comprehensive guidelines for discussing CAM. PRACTICE IMPLICATIONS: Given the concerns surrounding CAM use, it is critical to encourage informed decision-making about CAM and ultimately, improve outcomes for patients.

A systematic review of complex system interventions designed to increase recovery from depression in primary care.

BACKGROUND: Primary care is being encouraged to implement multiprofessional, system level, chronic illness management approaches to depression. We undertook this study to identify and assess the quality of RCTs testing system level depression management interventions in primary care and to determine whether these interventions improve recovery. METHOD: Searches of Medline and Cochrane Controlled Register of Trials. 'System level' interventions included: multi-professional approach, enhanced inter-professional communication, scheduled patient follow-up, structured management plan. RESULTS: 11 trials met all inclusion criteria. 10 were undertaken in the USA. Most focussed on antidepressant compliance. Quality of reporting assessed using CONSORT criteria was poor. Eight trials reported an increase in the proportion of patients recovered in favour of the intervention group, yet did not account for attrition rates ranging from 5 to 50%. CONCLUSION: System level interventions implemented in the USA with patients willing to take anti-depressant medication leads to a modest increase in recovery from depression. The relevance of these interventions to countries with strong primary care systems requires testing in a randomised controlled trial.