ABSTRACT
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.
Subject(s)
Breast Neoplasms , Cognitive Behavioral Therapy , Sleep Initiation and Maintenance Disorders , Humans , Female , Sleep Initiation and Maintenance Disorders/drug therapy , Sleep Initiation and Maintenance Disorders/complications , Breast Neoplasms/complications , Breast Neoplasms/drug therapy , Sleep , Cognitive Behavioral Therapy/methods , Phototherapy/methods , Treatment OutcomeABSTRACT
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.
Subject(s)
Breast Neoplasms , Sleep Initiation and Maintenance Disorders , Australia/epidemiology , Breast Neoplasms/complications , Breast Neoplasms/therapy , Cognition , Fatigue/etiology , Fatigue/therapy , Female , Humans , Phototherapy , Quality of Life , Sleep , Sleep Initiation and Maintenance Disorders/complications , Sleep Initiation and Maintenance Disorders/therapy , Treatment OutcomeABSTRACT
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.
Subject(s)
Breast Neoplasms , Cognitive Behavioral Therapy , Sleep Initiation and Maintenance Disorders , Australia , Breast Neoplasms/complications , Breast Neoplasms/drug therapy , Cognitive Behavioral Therapy/methods , Fatigue/complications , Fatigue/therapy , Female , Humans , Sleep Initiation and Maintenance Disorders/complications , Sleep Initiation and Maintenance Disorders/therapy , Treatment OutcomeABSTRACT
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.
Subject(s)
Breast Neoplasms , Sleep Initiation and Maintenance Disorders , Anxiety Disorders , Breast Neoplasms/complications , Depression , Fatigue/epidemiology , Female , Humans , Longitudinal Studies , Sleep Initiation and Maintenance Disorders/epidemiologyABSTRACT
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.
Subject(s)
Antineoplastic Agents/administration & dosage , Breast Neoplasms/drug therapy , Cognitive Behavioral Therapy/methods , Fatigue/therapy , Phototherapy/methods , Sleep Initiation and Maintenance Disorders/therapy , Administration, Intravenous , Adult , Aged , Aged, 80 and over , Anxiety/etiology , Anxiety/therapy , Australia , Breast Neoplasms/complications , Depression/etiology , Depression/therapy , Fatigue/etiology , Female , Follow-Up Studies , Humans , Mental Health , Middle Aged , Quality of Life , Randomized Controlled Trials as Topic , Self Report , Sleep , Sleep Initiation and Maintenance Disorders/etiology , Young AdultABSTRACT
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.