Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial.

BACKGROUND: Young adult cancer survivors (YACS) are at elevated risk for chronic insomnia, even years after completing treatment. In addition to potential health consequences, insomnia can interrupt social, educational, and vocational development just as they are trying to "make up" for time lost to cancer. Cognitive behavioral therapy for insomnia (CBTI) is recommended as first-line treatment for insomnia but remains largely unavailable to YACS due to several barriers (ie, shortage of trained providers, geographic limitations, financial limitations). Traditional CBTI has not been adapted to meet YACS' unique developmental and circadian challenges. To improve availability of effective behavioral insomnia treatment for this population, we developed the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA), a low-intensity educational intervention delivered virtually online. OBJECTIVE: In this phase 2 "proof of concept" trial, primary aims are to test the efficacy of STEP-YA to improve insomnia symptoms and mood in YACS and assess the utility of individualized coaching to improve treatment effects. A secondary aim will explore participant variables associated with clinically significant response to STEP-YA. METHODS: This 2-arm randomized prospective trial will enroll 74 off-treatment YACS aged 20 years to 39 years with clinically significant insomnia. Each participant completes the STEP-YA intervention in a 1-on-1 synchronous online session led by a trained interventionist following a structured outline. The 90-minute intervention presents educational information on the development of insomnia after cancer and offers specific suggestions for improving insomnia symptoms. During the session, participants review the suggestions and develop a personalized sleep action plan for implementing them. After the session, participants are randomized to either the coaching condition, in which they receive 2 telephone coaching sessions, or the no-coaching condition, which offers no subsequent coaching. The Insomnia Severity Index (ISI) and the Profile of Mood States: Short Form (POMS-SF) are assessed at baseline and 4 and 8 weeks postintervention. RESULTS: Enrollment began in November 2022, with 28 participants currently enrolled. We anticipate recruitment will be completed in 2024. The primary endpoint is a change in ISI score from baseline to 8 weeks postintervention. The secondary endpoint is change in mood symptoms (POMS-SF) from baseline to 8 weeks postintervention. Change scores will be treated as continuous variables. Primary analyses will use ANOVA methods. A within-subjects analysis will examine if the STEP-YA intervention is associated with significant changes in insomnia and mood over time. A 2-way ANOVA will be used to evaluate the utility of coaching sessions to improve treatment effects. CONCLUSIONS: Chronic insomnia has significant negative effects on YACS' medical, educational, and psychological functioning. STEP-YA aims to address their needs; study results will determine if the intervention warrants future effectiveness and dissemination studies and if individualized coaching is necessary for adequate treatment response. TRIAL REGISTRATION: ClinicalTrials.gov NCT05358951: https://clinicaltrials.gov/study/NCT05358951. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52315.

Validation of the Three-Item Insomnia Severity Index Short Form in Young Adult Cancer Survivors: Comparison with a Structured Diagnostic Interview.

Chronic insomnia affects ∼25% of young adult cancer survivors (YACS) but is often overlooked in routine follow-up. A recently introduced three-item version of the Insomnia Severity Index (ISI-3) was compared with a diagnostic interview (SCID-5) in 250 YACS (ages 18-40) to evaluate its validity in this population. The ISI-3 had good discrimination compared with the SCID-5 (area under the receiver operating characteristic curve = 0.88). Although no ISI-3 cutoff met study criteria for both sensitivity (≥0.85) and specificity (≥0.75), an ISI-3 cutoff of ≥4 had high sensitivity (94%) and moderate specificity (70%), and is recommended as the first step in a two-step screening procedure.

Validation of the Insomnia Severity Index (ISI) for identifying insomnia in young adult cancer survivors: comparison with a structured clinical diagnostic interview of the DSM-5 (SCID-5).

OBJECTIVES: Insomnia is a common problem affecting young adult cancer survivors (YACS) even years after treatment, yet it often goes unidentified and untreated. The Insomnia Severity Index is a widely-used insomnia measure, but has not been studied as an insomnia screener for YACS. The goal of this study was to validate the ISI in YACS by determining its utility in identifying YACS with insomnia disorder diagnosed with the Structured Clinical Interview for the DSM-5 (SCID-5). METHODS: 250 YACS completed the ISI and SCID-5 Insomnia Module. Area under the curve (AUC) was calculated to reflect the ISI's discrimination between YACS with and without SCID-5 insomnia disorder. An ISI cut-off score with sensitivity ≥0.85 and specificity ≥0.75 was deemed acceptable. RESULTS: Of 250 participants, 52 met criteria for SCID-5 insomnia disorder diagnosis. The ISI had excellent discrimination, with an AUC = 0.91. A cut-off score ≥8 met study clinical screening criteria with sensitivity of 0.85 and specificity of 0.77. A cut-off score ≥7 with a higher sensitivity (0.96) but lower specificity (0.70) was noted as a potential alternative. Cut-off scores ≥12 and ≥ 14 were recommended for applications prioritizing overall accuracy. CONCLUSIONS: Results support validity of the ISI for identifying YACS with insomnia disorder. For clinical screening, data support the use of an ISI cut-off score ≥8 in YACS, and additional cut-off scores were found for research purposes or higher sensitivity. Results of this study and prior studies of the ISI offer important reminders that cut-off scores derived from different populations are not generalizable.

Developing efficient and effective behavioral treatment for insomnia in cancer survivors: Results of a stepped care trial.

BACKGROUND: Insomnia is common among cancer survivors. Although behavioral treatments for insomnia are effective, access is limited. Stepped care delivery models may provide insomnia treatment that is more efficient and accessible to cancer survivors. METHODS: Fifty-one survivors (mean age, 55 years) with elevated Insomnia Severity Index (ISI) scores (≥12) first participated in Sleep Training Education Program (STEP)-1: a single, sleep education session. Those reporting elevated ISI scores 1 month later were offered STEP-2: a 3-session, group cognitive behavioral treatment for insomnia that has been demonstrated to be efficacious. Participants were considered treatment responders if their ISI score improved by ≥6 points and were considered as having remitted if their posttreatment ISI score was <12. Mood was assessed with the Profile of Mood States-Short Form (POMS-SF). RESULTS: Following STEP-1, ISI scores improved (17.1 to 11.2; P < .001), with 45% responding and 41% remitted. Insomnia remission after STEP-1 was associated with lower insomnia severity and shorter duration of sleep problems at baseline. Of the 30 (59%) survivors with unremitted insomnia after STEP-1, 14 (47%) participated in STEP-2. Following STEP-2, ISI scores improved (16.9 to 8.8; P < .001), with 79% responding and 71% remitted. STEP-2 participation was associated with interest in sleep treatment at baseline, but not demographic/health-related variables. Mood improved significantly following both STEP-1 and STEP-2 (P < .001). CONCLUSION: A stepped care approach to treating insomnia among cancer survivors has the potential to improve treatment accessibility. A sizable proportion of survivors can benefit from 2 different low-intensity approaches that could be delivered by nonsleep specialists. For individuals who require more intensive care, assessing treatment interest can identify those who are likely to engage.

Regional practice norms for the care of childhood cancer survivors at risk for cardiomyopathy: A Delphi study.

BACKGROUND: Treatment-associated cardiomyopathy is a leading cause of morbidity and mortality for childhood cancer survivors (CCS). As evidence is not available to guide the management of CCS at risk for cardiomyopathy, we aim to describe the collective opinion of regional experts for the care of these patients using a consensus-based Delphi methodology. PROCEDURE: Nineteen physicians from the New England region who care for CCS treated with cardiotoxic therapy (anthracyclines, thoracic radiation) participated in a Delphi panel querying their management approach, using three rounds of anonymous questionnaires formatted as five clinical scenarios. Consensus ≥ 89% agreement. RESULTS: The response rate was 100% for the first round and 95% for subsequent rounds. Panelists reached consensus on screening asymptomatic CCS with serial echocardiograms (94%) and electrocardiograms (89%), with some disagreement on frequency during pregnancy (83%). All panelists agreed with exercise promotion, with no restrictions on weight training. Consensus was reached on indications for referrals; cardiology for asymptomatic left ventricular dysfunction (ALVD) (100%) and maternal-fetal medicine for pregnancy (94%). In the scenario of ALVD, there was disagreement on the benefit of additional cardiac testing (50% cardiologists recommended cardiac MRI), and although all panelists endorsed treating with angiotension-converting enzyme (ACE) inhibitors, most adult cardiologists (75%) also recommended therapy with beta blockers, compared with none of the pediatric cardiologists or primary-care physicians. CONCLUSIONS: Despite a lack of evidence to guide the management of CCS at risk for cardiomyopathy, a panel of regional physicians reached consensus on managing most clinical scenarios. A controversial area requiring further study is the medical management of ALVD.

Finding sexual health aids after cancer: are cancer centers supporting survivors' needs?

PURPOSE: Sexual dysfunction is one of the most prevalent and distressing treatment-related side effects for both male and female cancer survivors. Survivorship care guidelines recommend therapeutic sexual aids to help improve sexual problems. However, little is known about the availability of sexual aids and resources at cancer centers. METHODS: Twenty-five comprehensive cancer centers affiliated with both the National Cancer Institute and the National Comprehensive Care Network were surveyed using the "mystery shopper" method to determine whether various types of sexual aids were available at the centers. Staffs from cancer center staff retail stores and patient boutiques were queried in separate telephone calls regarding the availability of these aids for and women. RESULTS: Of the 25 centers contacted, 23 (92%) responded about aids for men, and 22 (88%) responded about aids for women. Eighty-seven percent of the centers reported having no sexual aids available for men, and 72% of centers reported having no aids available for women. The most common advice given to mystery shoppers was a suggestion to use the internet. Only one center had numerous aids/resources for both men and women. CONCLUSIONS: The large majority of cancer centers reported having no sexual aids or other sexual health resources available for men or women. IMPLICATIONS FOR CANCER SURVIVORS: Results underscore the widespread lack of resources to promote sexual health rehabilitation at major cancer centers, both for male and female survivors.

Open-label placebo reduces fatigue in cancer survivors: a randomized trial.

PURPOSE: Cancer-related fatigue (CRF) is a common and challenging late effect for many cancer survivors. Clinical trials demonstrate robust placebo effects on CRF in blinded trials. Recently, open-label placebo (OLP) has been shown to improve a variety of symptoms in other populations. We conducted a randomized controlled trial to investigate the effect of OLP on CRF in cancer survivors, and to explore biologic and psychological correlates of placebo efficacy. METHODS: Forty cancer survivors (92.5% female; mean age 47.3 years) were randomized to OLP or no treatment control. OLP participants were prescribed two placebo tablets twice daily, for 3 weeks. All participants completed assessments at Baseline, Day 8, and Day 22. The primary endpoint was change in CRF (FACIT-F), and secondary outcomes included exercise frequency, mood, and quality of life. We examined whether personality characteristics or a genetic variation important in dopamine catabolism (catechol-O-methyltransferase; COMT) affected the placebo response. RESULTS: The OLP group reported significantly improved CRF at both Day 8 (p = 0.005) and Day 22 (p = .02), while the control group did not (ps > .05). CRF improvement differed by COMT genotype, but was not associated with personality characteristics. Marginal improvements were noted in the placebo group for some secondary outcomes (exercise frequency and quality of life), but not in the control group. CONCLUSIONS: Results demonstrate that even when administered openly, placebos improve CRF in cancer survivors and dopaminergic systems may be associated with this response. This novel research has meaningful implications for the use of OLP in symptom management for cancer survivors.

The management of childhood cancer survivors at risk for stroke: A Delphi survey of regional experts.

BACKGROUND: Evidence is not available to guide management of childhood cancer survivors (CCS) at risk for radiation-associated cerebral vascular disease (CVD) and stroke. We propose to use a consensus-based methodology to describe the collective opinion of regional experts for the care of these patients and identify areas of controversy. PROCEDURE: Thirty physicians from the New England region who care for CCS participated in a Delphi panel querying their management approach (imaging, laboratory tests, medications, counseling, referrals) to a CCS treated with cranial radiation formatted as five clinical scenarios (asymptomatic, small- and large-vessel CVD, transient ischemia, stroke) in three rounds of anonymous questionnaires. Consensus defined as ≥90% agreement. RESULTS: Response rate was 100% for all three rounds. Panelists reached consensus on laboratory tests to assess stroke risk factors, stroke risk and prevention counseling, brain imaging to monitor survivors with known CVD, and acute care for stroke symptoms. Only 67% panelists agreed with MRI screening asymptomatic survivors with no history of CVD, 87% endorsed aspirin as stroke prevention for large-vessel CVD and 57% for small-vessel CVD. There was no consensus on specialty referrals. Overall, panelists practicing at large institutions and neurology subspecialists were more likely to advocate for screening, interventions, and referrals. CONCLUSIONS: Despite lack of evidence to guide stroke prevention in CCS treated with cranial radiation, a panel of regional physicians reached consensus on managing most clinical scenarios. Controversial areas requiring further study are surveillance imaging for asymptomatic survivors, aspirin for stroke prevention, and indications for specialty referral.

Improvement in sexual function after ovarian cancer: Effects of sexual therapy and rehabilitation after treatment for ovarian cancer.

BACKGROUND: Sexual dysfunction is a distressing long-term effect after gynecological cancer and affects the majority of survivors for years after the completion of therapy. Despite its prevalence, treatment-related sexual dysfunction is underrecognized and undertreated for survivors. Thus, the aim of this study was to develop and test a brief psychoeducational intervention for managing sexual dysfunction for women who have undergone treatment for ovarian cancer (OC). METHODS: Forty-six OC survivors with documented, treatment-related sexual dysfunction received a single half-day group intervention that included sexual health education and rehabilitation training, relaxation and cognitive behavioral therapy skills to address sexual symptoms, and a single tailored booster telephone call 4 weeks after the group. Assessment measures were completed at the baseline (baseline 1), after an 8-week no-treatment run-in period (baseline 2), and then again 2 and 6 months after the intervention. The Female Sexual Function Index (FSFI) was used to assess sexual functioning, and the Brief Symptom Inventory 18 (BSI-18) was used to capture psychological distress. RESULTS: Between baseline 1 and baseline 2, there were no significant changes in the study measures, and this indicated no natural improvement during the run-in period. In contrast, the total FSFI scores improved significantly from baseline 1 to the 2- (n = 45; P < .0005) and 6-month time points (n = 42; P < .05). The BSI-18 scores were also significantly improved at the 2- (P < .005) and 6-month time points (P < .01) in comparison with baseline 1. CONCLUSIONS: This brief behavioral intervention led to significant improvements in overall sexual functioning and psychological distress that were maintained at the 6-month follow-up. The results demonstrate the feasibility of this brief, low-intensity behavioral intervention and support the development of a larger randomized controlled trial. Cancer 2018;124:176-82. © 2017 American Cancer Society.

Evaluation and treatment of insomnia in adult cancer survivorship programs.

PURPOSE: Insomnia is commonly experienced by cancer survivors. Chronic insomnia is associated with significant physical and psychosocial consequences if not properly treated. Both the National Cancer Institute (NCI) and the National Comprehensive Cancer Network (NCCN) recommend the evaluation of sleep disturbances and evidence-based treatment of insomnia during routine survivorship care. To better understand current clinical practices, we conducted a survey of major cancer centers across the United States (US). METHODS: Adult survivorship programs at the 25 US cancer centers that are both NCI-designated comprehensive cancer centers and NCCN member institutions were surveyed about the evaluation and treatment of insomnia in their hospital. RESULTS: All institutions responded to the survey. Thirteen centers (56 %) reported screening <25 % of survivors for sleep disorders, and few clinicians providing survivorship care were well-prepared to conduct a proper sleep evaluation. Insomnia was most commonly treated with sleep hygiene, or pharmacotherapy, rather than cognitive-behavioral therapy. No program reported that >50 % of their survivors were receiving optimal insomnia-related care. A variety of methods to improve insomnia care were endorsed by respondents. CONCLUSIONS: There is a clear need to improve the evaluation and treatment of insomnia for cancer survivors at institutions across the country. Cancer centers deemed a number of modalities relevant for improving provider confidence in addressing sleep challenges. IMPLICATIONS FOR CANCER SURVIVORS: To improve the quality of insomnia care for survivors, systematic interventions to increase standardized screening for sleep disorders, providing additional sleep medicine training for survivorship clinicians, and optimizing the role of sleep medicine specialists in the oncology setting should be considered.