Optimising Patient Outcomes in Tongue Cancer: A Multidisciplinary Approach.

A multidisciplinary approach to the management of tongue cancer is vital for achieving optimal patient outcomes. Nursing and allied health professionals play essential roles within the team. We developed symposia comprising a series of online lectures offering a detailed perspective on the role each discipline and consumer perspective has in the management of patients with tongue cancer. The topics, including epidemiology and prevention, diagnosis, treatment planning, surgery, adjuvant care, and the management of recurrent or metastatic disease, were thoroughly examined. The symposia highlighted the significance of fostering collaboration and continuous learning through a multidisciplinary approach. This initiative should be relevant to healthcare professionals, researchers, and policymakers striving to enhance patient outcomes in tongue cancer care through innovative collaboration.

Evaluating the Feasibility and Acceptability of a Psychosexual Intervention for Couples Post-allogeneic Hematopoietic Stem Cell Transplantation.

PURPOSE: Allogeneic hematopoietic stem cell transplantation (HSCT) can have a long-term impact on patients' sexual functioning and consequently, their relationship satisfaction. This study aimed to examine the feasibility and acceptability of a 5-session psychosexual intervention for HSCT survivors and their partners. METHODS: To be eligible patients were required to be more than 3 months post-allogeneic HSCT. The intervention comprised 2 components: (1) A psychosexual education session exploring medical/behavioral treatment options for sexual dysfunction, delivered by a specialist nurse; (2) A 4-session Emotionally-Focused Therapy-based relationship education program for couples delivered by a clinical psychologist. Measures assessing relationship quality, sexual functioning, anxiety, and depression were administered pre- and post-intervention. Feasibility was measured via participation rate, adherence and compliance with completing main measures. Acceptability of the intervention was assessed via patient/partner satisfaction surveys. RESULTS: Eight of 85 (9.4%) eligible patients and their partners participated in the study. Reasons for declining participation included: feeling uncomfortable due to sensitive nature of intervention; did not have any relationship/sexual function issues; and experiencing ongoing medical issues. Six of 8 couples (75%) attended at least 4 intervention sessions and 5 of 8 (62.5%) completed the main study measures post-intervention. Four couples reported that sexual satisfaction and relationship satisfaction was somewhat or much better post-intervention; 1 reported no change. CONCLUSION: Feasibility criteria were not met, with low enrolment rate, however the intervention was deemed acceptable. Couples who participated adhered to the intervention and considered it beneficial. Further strategies to identify and manage sexual concerns are required.

Self-perceptions of masculinities and testicular cancer: Qualitative explorations.

OBJECTIVE: Masculinities have been explored in men with testicular cancer (TC), though limited contemporary research is available on traditional masculine norms important to masculine self-perception. The purpose of this research was to explore the discourse of TC experience in relation to masculine self-perception. METHODS: A qualitative descriptive study was conducted consisting of semi-structured interviews with 21 men. Men were aged between 31 and 47 (Mage = 35.7). Most men were diagnosed with Stage 1 cancer (66.6%), all men had finished active treatment and time since diagnosis ranged from 17.3 to 71.8 months (M = 47.2). Independent coding was conducted by two researchers and was refined in coding meetings with authors. Themes were developed in a predominantly deductive manner, and analysis of themes was undertaken using a reflexive analysis approach. RESULTS: Traditional masculine norms showed differing relationships to masculine self-perception. Two main themes were identified [1] Maintained or enhanced masculine self-perception and [2] threats to masculine self-perception. Subthemes demonstrated that maintaining emotional control, strength and 'winning' was important to men, and reduced physical competencies (i.e., strength, sexual dysfunction, virility) challenged self-perception. Strict adherence to traditional norms in response to threatened self-perception related to psychological distress. CONCLUSION: Leveraging traditionally masculine norms such as physical strength and control and developing flexible adaptations of masculinities should be encouraged with men with TC to retain self-perception and potentially enable better coping. Masculine self-perception of gay/bisexual men may centre around sexual functioning, though further research is required.

Malignancy, masculinities, and psychological distress: Comparisons made between men with testicular cancer and healthy controls.

OBJECTIVE: Psychological distress is common in men with testicular cancer (TC), and masculinities may work to explain this. This study aimed to compare masculinities and distress in TC and healthy control (HC) populations and explore relationships between correlates of distress (psychological flexibility and coping style) and masculinities in TC. METHODS: A cross-sectional, online survey was completed by 92 men with TC (Mage  = 34.8) and 90 HC (Mage  = 30.7). Measures included psychological distress (Patient-Reported Outcomes Measurement Information System Depression/Anxiety, fear of cancer recurrence inventory-short form), masculinities (gender role conflict-short form, inventory of subjective masculinity experiences/subjective masculinity stress scale, masculinity in chronic disease inventory), coping style (mini-mental adjustment to cancer ) and psychological flexibility (comprehensive assessment of acceptance commitment therapy). Linear regressions were conducted to compare groups and analyse associations. RESULTS: There were no differences in masculinities or psychological distress between populations (all p > 0.05 and all Cohen's d < 0.20), except for subjective masculine stress and restrictive affectionate behaviour between men. For men with TC, restrictive affection/emotion, conflicts between family/work and subjective masculine stress were associated with psychological distress (rs 0.21-0.58). Optimistic action was negatively associated with depression/anxiety, helplessness/hopelessness coping (rs -0.27 to -0.42) and positively associated with psychological flexibility (r = 0.35). CONCLUSIONS: Masculinities are implicated in psychological distress in men with TC. Psychological flexibility as well as leveraging masculine beliefs (e.g., optimistic action) may be modifiable targets to reduce distress in men with TC.

Exploring the experiences of staff conducting psychology consultations via telehealth in an oncology hospital.

PURPOSE: During the COVID-19 pandemic, telehealth delivery of psychological care services expanded to meet the needs of people with cancer. This study examined psychologists' attitudes toward using telehealth during the pandemic peak in a tertiary oncology hospital. METHODS: Semi-structured interviews were conducted with ten psychologists who used telehealth to deliver psychological services. Thematic analysis was conducted to identify themes in the interview data. RESULTS: Themes identified: (1) increased uptake and attendance of psychology sessions was due to greater accessibility of services; (2) clinicians reported ease of communication and building of rapport when using telehealth; and (3) clinicians perceived differences in the psychotherapeutic process when sessions were delivered via telehealth compared to in-person. CONCLUSIONS: Clinicians expressed high satisfaction with delivering telehealth psychological support for oncology patients. Implications for Psychosocial Providers: Oncology services that are considering developing or expanding a telehealth psychology service can facilitate this by ensuring a reliable technological platform and providing training and/or support to staff and patients. Clinicians should also use their clinical judgment to decide if a patient is appropriate for telehealth-delivered psychological care or if a mix of modalities is more ideal.

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.

Virtual Delivery of Stepped-Care Cognitive Behaviour Therapy for Cancer Related Fatigue: A Feasibility Study.

PURPOSE: About 1 in 3 people experience persistent fatigue after cancer treatment. People with severe fatigue describe a disabling lack of stamina, anxiety, depression and distressing cognitive changes. Cognitive behavior therapy (CBT) is recommended for people with severe fatigue after cancer treatment, however due to limited resources and lack of available clinicians very few people with cancer have access. This study explored feasibility of a virtual stepped-care CBT program. METHODS: English speaking adults experiencing persistent fatigue who had either completed cancer treatment, or with stable disease on maintenance therapies were recruited. All participants engaged in a 6-week supported self-help program using a CBT workbook targeting fatigue (STEP 1). After the self-help program, participants with severe ongoing fatigue were stepped-up to a telehealth CBT group focused to fatigue led by a Clinical Psychologist (STEP 2). Feasibility and perceived changes were assessed at baseline, 6 and 12 weeks. RESULTS: Of 19 participants, 17 completed STEP 1 and 8 completed STEP 2. Remotely delivered CBT was feasible with high retention, adherence, participant feasibility and satisfaction scores. Cost to deliver STEP 1 was AUD $145 and STEP 2, AUD $280 per participant. Overall, fatigue and self-efficacy improved significantly following STEP 1. Participants with higher baseline fatigue achieved limited improvements with self-help alone, requiring guidance to set achievable goals and reframe cognitions. Fatigue, self-efficacy and mood improved with STEP 2. CONCLUSIONS: Remotely delivered CBT for cancer fatigue was feasible. The effectiveness of stratified rather than stepped CBT approach, based on fatigue severity should be trialed. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN # 11 12622000420741).

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.

INTRODUCTION: People 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 concerns requiring specific attention. These include the need for people with prolonged survival to reframe their life plans and tolerate uncertainty related to treatment duration and prognosis. A brief intervention for people with advanced cancer, Managing Cancer and Living Meaningfully (CALM), could help people treated with IT or TT address these concerns. However, CALM has not been specifically evaluated in this population. This study aims to evaluate the acceptability and feasibility of CALM in people with advanced NSCLC treated with IT or TT and obtain preliminary evidence regarding its effectiveness in this population. METHODS AND ANALYSIS: Twenty people with advanced NSCLC treated with IT or TT will be recruited from Peter MacCallum Cancer Centre, Melbourne, Australia. Participants will complete three to six sessions of CALM delivered over 3-6 months. A prospective, single-arm, mixed-methods pilot study will be conducted. Participants will complete outcome measures at baseline, post-intervention, 3 months and 6 months, including Patient Health Questionnaire, Death and Dying Distress Scale, Functional Assessment of Cancer Therapy General and Clinician Evaluation Questionnaire. The acceptability of CALM will be assessed using patient experiences surveys and qualitative interviews. Feasibility will be assessed by analysis of recruitment rates, treatment adherence and intervention delivery time. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/82047/PMCC). Participants with cancer will complete a signed consent form prior to participation, and carers and therapists will complete verbal consent. Results will be made available to funders, broader clinicians and researchers through conference presentations and publications. If CALM is found to be acceptable in this cohort, this will inform a potential phase 3 trial.

The Psychological and Wellbeing Impacts of Quarantine on Frontline Workers during COVID-19 and Beyond.

OBJECTIVE: The current study investigated the experiences, wellbeing impacts, and coping strategies of frontline workers who participated in "Hotels for Heroes", an Australian voluntary hotel quarantine program during the COVID-19 pandemic. The program was open to those who were COVID-19 positive or exposed to COVID-19 as part of their profession. METHODS: Frontline workers who had stayed in voluntary quarantine between April 2020 and March 2021 were invited to participate in a voluntary, anonymous, cross-sectional online survey including both quantitative and qualitative responses. Complete responses were collected from 106 participants, which included data on sociodemographic and occupational characteristics, experiences of the Hotels for Heroes program, and validated mental health measures. RESULTS: Mental health problems were prevalent amongst frontline workers (e.g., moderate anxiety symptoms, severe depression symptoms, and greater than usual impact of fatigue). For some, quarantine appeared to be helpful for anxiety and burnout, but quarantine also appeared to impact anxiety, depression, and PTSD negatively, and longer stays in quarantine were associated with significantly higher coronavirus anxiety and fatigue impacts. The most widely received support in quarantine was from designated program staff; however, this was reportedly accessed by less than half of the participants. CONCLUSIONS: The current study points to specific aspects of mental health care that can be applied to participants of similar voluntary quarantine programs in the future. It seems necessary to screen for psychological needs at various stages of quarantine, and to allocate appropriate care and improve its accessibility, as many participants did not utilise the routine support offered. Support should especially target disease-related anxiety, symptoms of depression and trauma, and the impacts of fatigue. Future research is needed to clarify specific phases of need throughout quarantine programs, and the barriers for participants receiving mental health supports in these contexts.

Evaluation of the validity and screening performance of a revised single-item fear of cancer recurrence screening measure (FCR-1r).

OBJECTIVE: Fear of cancer recurrence (FCR) is highly prevalent among cancer survivors, but irregularly identified in practice. Single-item FCR measures suitable for integration into broader psychosocial screening are needed. This study evaluated the validity of a revised version of the original FCR-1 (FCR-1r) and screening performance alongside the Edmonton Symptom Assessment System - Revised (ESAS-r) anxiety item. METHODS: The FCR-1r was adapted from the FCR-1 and modelled on the ESAS-r. Associations between FCR-1r and FCR Inventory-Short Form (FCRI-SF) scores determined concurrent validity. Relationships of FCR-1r scores with variables related (e.g., anxiety, intrusive thoughts) and unrelated (e.g., employment/marital status) to FCR determined convergent and divergent validity respectively. A Receiver-Operating Characteristic analysis examined screening performance and cut-offs for the FCR-1r and ESAS-r anxiety item. RESULTS: 107 participants were recruited in two studies (Study 1, July-October 2021, n = 54; Study 2: November 2021-May 2022, n = 53). The FCR-1r demonstrated concurrent validity against the FCRI-SF (r = 0.83, p < 0.0001) and convergent validity versus the Generalised Anxiety Disorder-7 (r = 0.63, p < 0.0001) and Impact of Event Scale-Revised Intrusion subscale (r = 0.55, p < 0.0001). It did not correlate with unrelated variables (e.g., employment/marital status), indicating divergent validity. An FCR-1r cut-off ≥5/10 had 95% sensitivity and 77% specificity for detecting clinical FCR (area under the curve (AUC) = 0.91, 95% CI 0.85-0.97, p < 0.0001); ESAS-r anxiety cut-off ≥4 had 91% sensitivity and 82% specificity (AUC = 0.87, 95% CI 0.77-0.98, p < 0.0001). CONCLUSIONS: The FCR-1r is a valid and accurate tool for FCR screening. Further evaluation of the screening performance of the FCR-1r versus the ESAS-r anxiety item in routine care is needed.

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.

Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease.

BACKGROUND: Fear of cancer recurrence (FCR) is a significant unmet need amongst cancer survivors and is consistently associated with psychological distress and impaired quality of life. Psychological interventions for FCR, such as ConquerFear, have demonstrated efficacy in reducing FCR and improving emotional wellbeing. Unfortunately, there are barriers to the uptake of evidence-based FCR treatments in clinical practice. A stepped-care FCR treatment model may overcome these barriers and has demonstrated potential in people with advanced melanoma. This study aims to evaluate the acceptability, feasibility, and impact of a stepped-care FCR treatment model (Fear-Less) in people with other cancer types, who have completed treatment with curative intent. METHODS: Sixty people with early-stage cancer (defined as individuals who have received treatment with curative intent and with no metastatic disease) will be screened for FCR using the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Individuals reporting moderate FCR (FCRI-SF between 13 and 21) will be offered a clinician-guided self-management resource; those reporting high FCR (FCRI-SF ≥ 22) will be offered individual therapy according to the ConquerFear protocol. Participants will complete purpose-built evaluation surveys assessing their FCR screening and intervention experiences. Clinicians will also complete a survey regarding their experiences of the treatment model. Fear-Less will be evaluated in terms of (1) acceptability (i.e., patient and clinician experience), (2) feasibility (i.e., referral uptake, treatment adherence, and time taken to screen and deliver interventions), and (3) impact (i.e., pre- to post-intervention FCR changes). DISCUSSION: The Fear-Less stepped-care model is a novel framework for screening FCR and stratifying survivors to the appropriate level of treatment. Our study will provide an indication of whether Fear-Less is a feasible and acceptable FCR model of care amongst survivors with early-stage disease and inform further investigations of this model. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12622000818730 .

AYA 'Can-Sleep' programme: protocol for a stepped-care, cognitive behavioural therapy-based approach to the management of sleep difficulties in adolescents and young adults with cancer.

BACKGROUND: Sleep problems are reported in up to 50% of adolescents and young adults (AYA) with cancer. Cognitive behavioural therapy for insomnia (CBTi) is considered the gold-standard treatment. In the AYA population, CBTi is associated with improvements in insomnia, daytime sleepiness, fatigue and quality of life. In adults, stepped-care interventions can improve accessibility to CBTi. This study aims to evaluate the acceptability and feasibility of a stepped-care CBTi programme in AYA with cancer. METHODS AND ANALYSIS: AYA (target N = 80) aged 16-25 with a diagnosis of cancer will be screened using the Insomnia Severity Index (ISI) and Epworth Sleepiness Scale (ESS). When sleep difficulties are identified by the ISI and/or ESS, they will be screened for obstructive sleep apnoea and restless leg syndrome and referred to a sleep service if indicated. The remainder with sleep difficulties will be offered a stepped-care sleep programme including CBT self-management and coaching (first step). Participants will then be rescreened at 5 weeks, and those with ongoing sleep difficulties will be offered individualised CBT (second step). Recruitment and retention rates, adherence to intervention and time taken to deliver screening and intervention will be collected to assess the feasibility of the programme. AYA and clinicians will complete evaluation surveys to assess the acceptability of the AYA Can-Sleep programme. DISCUSSION: We seek to contribute to the evidence base regarding screening and treatment of sleep difficulties in the AYA population by implementing the AYA Can-Sleep programme and determining its feasibility and acceptability as an approach to care in an Adolescent & Young Adult Cancer Service.

The impact of testicular cancer and its treatment on masculinity: A systematic review.

OBJECTIVE: The purpose of this review was to synthesise the literature on the topic of masculinity and testicular cancer (TC) and investigate the relative impact of TC on men's view of their masculinity. METHODS: Searches were conducted across four databases (MEDline, PsycInfo, CINAHL Plus and Scopus) for articles published before April 2022 that included (1) TC and (2) masculinity. Two researchers independently rated studies for inclusion with a third resolving conflicts. Of the 6464 articles screened, 24 articles (10 quantitative and 14 qualitative) were included in the review. Articles were rated for quality and a narrative synthesis was performed. RESULTS: Overall, results indicated some men experience a shift in the way they relate to their sense of masculinity following diagnosis and treatment for TC. Being single and without children was related to the experience of negative masculinity-related outcomes, possibly due to a compounding lack of relational support and being unable to conform to protector, provider traditions. Men who described testicle loss as symbolic of their diminished masculinity were also negatively impacted. However, recent, high-quality literature on the topic using standardised masculinity measures was limited. CONCLUSION: Some men experience a reduced sense of masculinity after TC, however the impact of TC on masculinity remains person dependent. Further research using validated masculinity measures is required to uncover psycho-social variables that may account for whether and how meaning is made between TC and its treatment and any subsequent impact on perceived masculinity. Such factors may better support these men in life beyond cancer. SYSTEMATIC REVIEW REGISTRATION: PROSPERO. International Prospective Register of Systematic Reviews: CRD42020185649.

Stepped-care cognitive behaviour therapy program for treating cancer-related fatigue: protocol for a feasibility study.

BACKGROUND: Cancer-related fatigue (CRF) is a commonly experienced and often debilitating side effect of cancer treatment that can persist for years after treatment completion. The benefits of cognitive behaviour therapy (CBT) for CRF are well established; however, these interventions are typically not included in standard clinical care. Traditional CBT is resource-intensive, limiting implementation in hospital settings. Stepped-care approaches can offer benefits to more people, using the same personnel as traditional models. METHOD/DESIGN: This is a single-arm feasibility study. Fifty people with a cancer diagnosis, at least 12 weeks post-treatment or on long-term maintenance treatment, with persistent CRF that is affecting daily activities, will enrol in a stepped-care CBT program. INTERVENTION: The stepped-care program involves two steps. Step 1: All participants begin with a 5-week supported self-management CBT progam targeting fatigue. Step 2: If fatigue remains severe or has changed less than the minimal clinically important difference on the fatigue measure after step 1, participants will be offered four sessions of therapist-directed group CBT. MEASURES: Participants will complete questionnaires at baseline and 6 and 10 weeks. The primary outcome is feasibility of the REFRESH program. The implementation evaluation comprises acceptability, satisfaction, appropriateness, and feasibility of the study intervention, along with administrative data including cost, processes, procedures and implementation. Secondary outcomes are changes in fatigue, quality of life and self-efficacy. CONCLUSION: The REFRESH program will be the first stepped-care CBT intervention for persistent CRF in Australia. Assessing feasibility of REFRESH is an important first step to establishing future implementation and efficacy.

The effectiveness of a media-based intervention promoting help-seeking for mental health difficulties by Australian men: study protocol for a randomised controlled trial.

BACKGROUND: Approximately one fifth of Australian males aged 16+ experience mood, anxiety or substance use disorders in a given year, and suicide by males accounts for three quarters of all suicides annually. However, males with mental health problems are less likely to seek and receive help than their female counterparts. Media campaigns with videos at their core are gaining popularity as a means of promoting help-seeking for mental health difficulties, but few studies have rigorously tested the impact of such videos. This randomised controlled trial tests the effectiveness of a short video promoting help-seeking by Australian men. METHODS: This study is an online randomised controlled trial (RCT). Participants will attend an online group orientation session, where they will provide consent to participate and complete a baseline questionnaire (T1). After completion of the T1 questionnaire, participants will be randomised to watch either the intervention or control video on a 1:1 basis. After randomisation, participants will be able to access their allocated video for 1 week. Seven days after T1, participants will again be sent links to the video and to the post-exposure questionnaire (T2). One month after T2, participants will be emailed the follow-up questionnaire (T3). The primary outcome will be change in help-seeking intentions from T1 to T2. Secondary outcomes will be changes in help-seeking intentions from T1 to T3, changes in intentions to encourage other males to seek help, self-reliance, and male depression symptoms from T1 to T2 and from T1 to T3. The cost-effectiveness of the intervention will be evaluated. Participants will also complete questions about their opinions of the video and its effects at T2 and T3. DISCUSSION: Our video-based intervention is designed to promote help-seeking for mental health difficulties among Australian men. If a lack of net harm is shown to be associated with viewing the intervention video, the video will be publicly released and could have broad impacts on individual and community attitudes towards help-seeking for mental health difficulties, and ultimately enhance men's mental health and wellbeing. An evaluation of the effectiveness of the intervention is essential to ensure the intervention is achieving its objectives. TRIAL REGISTRATION: anzctr.org.au 12621001008819.

Effects of media stories of hope and recovery on suicidal ideation and help-seeking attitudes and intentions: systematic review and meta-analysis.

BACKGROUND: There is strong evidence that suicides increase after media stories about suicides by celebrities, particularly those that highlight the suicide method (the Werther effect). Much less is known about the Papageno effect-the protective effects of media stories of hope and recovery from suicidal crises. A synthesis of the retrievable evidence is lacking. We aim to summarise findings from randomised controlled trials about the effects of stories of hope and recovery on individuals with some degree of vulnerability to suicide. METHODS: For this systematic review and individual participant data meta-analysis, we searched PubMed (including MEDLINE), Scopus, Embase, PsycInfo, Web of Science, and Google Scholar published from inception to Sept 6, 2021, without language restrictions. We included trials that reported suicidal ideation (the primary outcome) or help-seeking attitudes or intentions (the secondary outcome) and tested a media narrative of hope and recovery. Studies were excluded if they did not feature a clearly positive story of hope and recovery, or had a control group exposed to suicide-related stimulus material. We contacted the lead or senior authors of all original studies to obtain participant-level data for this study. The primary analysis was restricted to individuals with some vulnerability to suicide. Risk of bias was assessed using the Cochrane risk-of-bias tool for randomised trials. The study is registered with PROSPERO, number CRD42020221341. FINDINGS: Our search yielded 7347 records. 3920 records were screened by title and abstract, and 25 full-text records assessed for eligibility. There were eight eligible studies with 2350 participants for which individual participant data were sought. For suicidal ideation, six studies met the inclusion criteria for the primary analysis. Follow-up responses were available for 569 (90%) of 633 participants who were randomised with high vulnerability (345 [55%] allocated to the intervention group and 288 [45%] to the control group). The pooled standardised mean difference (SMD) indicated a small reduction in suicidal ideation of -0·22 (95% CI -0·39 to -0·04, p=0·017; six studies) in the intervention group. For help-seeking attitudes and intentions, four studies met the inclusion criteria and follow-up data were available for 362 (86%) of 420 participants (247 [59%] allocated to the intervention group and 173 [41%] to the control group). The pooled SMD showed no evidence of a difference between the groups (SMD=0·14, 95% CI -0·15 to 0·43, p=0·35; four studies). Low levels of cross-study heterogeneity effects were observed for both analyses (I2=5% [suicidal ideation] and I2=36% [help-seeking attitudes and intentions]). We found no evidence of publication bias. INTERPRETATION: Media narratives of hope and recovery from suicidal crises appear to have a beneficial effect on suicidal ideation in individuals with some vulnerability, but there is insufficient evidence regarding help-seeking attitudes and intentions. These findings provide new evidence about narratives for suicide prevention. FUNDING: None.

Efficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer: study protocol for a randomised controlled trial.

INTRODUCTION: Fear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted. METHODS AND ANALYSIS: A single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (12620000645954); Pre-results. Registered 6 June 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379520&isReview=true.

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.