Sequential multiple assignment randomized trial design is becoming increasingly used in the field of precision medicine. This design allows comparisons of sequences of adaptive interventions tailored ...to the individual patient. Superiority testing is usually the initial goal in order to determine which embedded adaptive intervention yields the best primary outcome on average. When direct superiority is not evident, yet an adaptive intervention poses other benefits, then non-inferiority testing is warranted. Non-inferiority testing in the sequential multiple assignment randomized trial setup is rather new and involves the specification of non-inferiority margin and other important assumptions that are often unverifiable internally. These challenges are not specific to sequential multiple assignment randomized trial and apply to two-arm non-inferiority trials that do not include a standard-of-care (or placebo) arm. To address some of these challenges, three-arm non-inferiority trials that include the standard-of-care arm are proposed. However, methods developed so far for three-arm non-inferiority trials are not sequential multiple assignment randomized trial-specific. This is because apart from embedded adaptive interventions, sequential multiple assignment randomized trial typically does not include a third standard-of-care arm. In this article, we consider a three-arm sequential multiple assignment randomized trial from an National Institutes of Health-funded study of symptom management strategies among people undergoing cancer treatment. Motivated by that example, we propose a novel data analytic method for non-inferiority testing in the framework of three-arm sequential multiple assignment randomized trial for the first time. Sample size and power considerations are discussed through extensive simulation studies to elucidate our method.
Purpose
Cancer diagnosis and treatment can generate substantial distress for both survivors and their family caregivers. The primary aim of this investigation is to test a model of dyadic ...interdependence in distress experienced by cancer survivors and their caregivers to determine if each influences the other.
Methods
To test this prediction, 209 Latinas with breast cancer and their family caregivers (dyads) were followed for 4 waves of assessment over the course of 6 months. Both psychological (depression, anxiety, perceived stress) and physical (number of symptoms, symptom distress) indicators of distress were assessed. Longitudinal analyses of dyadic data were performed in accordance with the actor-partner interdependence model.
Results
Findings indicated that psychological distress was interdependent between cancer survivors and their caregivers over the 6 months of observation. However, there was no such evidence of interdependence on indicators of physical distress.
Conclusions
These findings are consistent with emotional contagion processes and point to the potential importance of caregiver well-being for the welfare of Latina breast cancer survivors.
Purpose
To examine symptom responses resulting from a home-based reflexology intervention delivered by a friend/family caregivers to women with advanced breast cancer undergoing chemotherapy, ...targeted, and/or hormonal therapy.
Methods
Patient-caregiver dyads (
N
= 256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained by a reflexology practitioner in a 30-min protocol. During the 4 weeks, both groups completed telephone symptom assessments using the M. D. Anderson Symptom Inventory. Those who completed at least one weekly call were included in this secondary analysis (
N
= 209). Each symptom was categorized as mild, moderate, or severe using established interference-based cut-points. Symptom response meant an improvement by at least one category or remaining mild. Symptom responses were treated as multiple events within patients and analyzed using generalized estimating equations technique.
Results
Reflexology was more successful than attention control in producing responses for pain (OR = 1.84, 95% CI (1.05, 3.23),
p
= 0.03), with no significant differences for other symptoms. In the reflexology group, greater probability of response across all symptoms was associated with lower number of comorbid condition and lower depressive symptomatology at baseline. Compared to odds of responses on pain (chosen as a referent symptom), greater odds of symptom response were found for disturbed sleep and difficulty remembering with older aged participants.
Conclusions
Home-based caregiver-delivered reflexology was helpful in decreasing patient-reported pain. Age, comorbid conditions, and depression are potentially important tailoring factors for future research and can be used to identify patients who may benefit from reflexology.
Trial registration
ClinicalTrials.gov
Identifier: NCT01582971
The series is devoted to the publication of monographs and high-level textbooks in mathematics, mathematical methods and their applications. Apart from covering important areas of current interest, a ...major aim is to make topics of an interdisciplinary nature accessible to the non-specialist. The works in this series are addressed to advanced students and researchers in mathematics and theoretical physics. In addition, it can serve as a guide for lectures and seminars on a graduate level. The series de Gruyter Studies in Mathematics was founded ca. 30 years ago by the late Professor Heinz Bauer and Professor Peter Gabriel with the aim to establish a series of monographs and textbooks of high standard, written by scholars with an international reputation presenting current fields of research in pure and applied mathematics. While the editorial board of the Studies has changed with the years, the aspirations of the Studies are unchanged. In times of rapid growth of mathematical knowledge carefully written monographs and textbooks written by experts are needed more than ever, not least to pave the way for the next generation of mathematicians. In this sense the editorial board and the publisher of the Studies are devoted to continue the Studies as a service to the mathematical community. Please submit any book proposals to Niels Jacob.
Purpose
To compare costs and relative cost savings from reductions in unscheduled health services use for two 8-week psychosocial interventions (telephone interpersonal counseling TIPC, supportive ...health education SHE) delivered by telephone to Latinas with breast cancer and their informal caregivers. Cost information is required before adopting supportive care interventions as part of routine care. There is limited information on costs of producing supportive care interventions or their impact on service use.
Methods
Latinas and their caregivers were randomized to either TIPC or SHE. At baseline and month 4, hospitalizations and urgent care and emergency department (ED) visits in the previous month were recorded. These were compared by trial arm for 181 survivors and 169 caregivers using logistic regression, adjusting for age and health services use at baseline.
Results
Total cost per 100 survivors was $28,695 for SHE and $27,399 for TIPC. Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) 0.12, 0.88,
p
= .03). For hospitalizations, OR for SHE versus TIPC was 0.59, 95% CI 0.26, 1.37,
p
= .07. There were no differences between trial arms for caregiver health services use. Cost savings for SHE versus TIPC from reductions in health services use per 100 survivors ranged from $800 for urgent care to $17,000 for ED visits and $13,000 for hospitalizations.
Conclusions
Based on this evidence, SHE can be a cost-saving supportive care solution that benefits not only survivors and caregivers, but also oncology practices reimbursed through episodes of care.
Intimate Partner Violence (IPV) is a significant public health problem often associated with serious mental health and physical health implications. Substance use disorders (SUDs) are one of the most ...common comorbidities among women with IPV, increasing risk of subsequent IPV.
The current study examined the feasibility, acceptability, and preliminary effectiveness of a brief computerized intervention to reduce alcohol and drug use among women with IPV. Fifty women with recent IPV and alcohol and drug use risk were recruited from domestic violence shelters and randomized to the experimental computerized intervention or to an attention and time control condition. The primary outcome was percent heavy drinking or drug using days in 3 month increments over the 6 months after leaving the shelter. Receipt of substance use services and IPV severity were evaluated as secondary outcomes.
The computerized intervention was feasible and acceptable, with high (n = 20, 80%) completion rates, engagement with the intervention, and satisfaction scores. As expected in this pilot trial, there were no significant differences between conditions in percent heavy drinking/drug using days or receipt of substance use services and large individual differences in outcomes. For example, receipt of substance use services decreased by a mean of 0.05 times/day from the baseline to the 6-month time period in the control condition (range -1.00 to +0.55) and increased by a mean of 0.06 times/day in the intervention condition (range -0.13 to +0.89). There were large decreases in IPV severity over time in both conditions, but directions of differences favored the control condition for IPV severity.
A computerized intervention to reduce the risk of alcohol/drug use and subsequent IPV is feasible and acceptable among residents of a domestic violence shelter. A fully powered trial is needed to conclusively evaluate outcomes.
We tested a model of dyadic interdependence in depression symptoms experienced by female caregivers living with HIV in Uganda (n = 288) and behavioral problems of their HIV-infected (n = 92) and ...perinatally HIV-exposed uninfected (HEU) children (n = 196). Three repeated measures of caregiver depression symptoms and child neurodevelopment and behavioral outcomes were related to their own outcomes at a previous time point (actor effects), and the outcomes of the other member of the dyad (partner effects). Caregiver depression and child behavioral problem were interdependent over the 24 months of observation. Caregiver depression at T
n
predicted child’s behavioral problems at T
n+1
(coefficient = 0.1220,
SE
= 0.0313,
p
< 0.01); child behavioral problems at T
n
predicted maternal depression at T
n+1
(coefficient = 0.0984,
SE
= 0.0253,
p
< 0.01). Results suggest the importance of services addressing behavioral needs of affected children and mental health of their mothers.
Cancer survivors (defined as individuals from diagnosis to the end of life) in treatment experience multiple physical and psychological symptoms (e.g., fatigue, pain, depression, anxiety, disturbed ...sleep) that influence their well-being and treatment outcomes. Underrepresented cancer survivors may disproportionately experience greater symptom burden (number of symptoms, symptom severity, depression, anxiety).
The aim of this study was to examine the relationships of social determinants of health, including age, ethnicity, education, income and whether income meets the survivor's needs, neighborhood (rural vs. urban), access to healthcare (e.g., insurance), and social isolation, with symptom burden in cancer survivors.
This secondary analysis included baseline data from 400 cancer survivors of solid tumor cancers undergoing chemotherapy or targeted therapy who participated in a larger randomized trial of symptom management interventions. Symptom burden was measured by the Center for Epidemiological Studies-Depression scale for depression and Patient-Reported Outcomes Measurement Information System scores for anxiety and social isolation, summed severity index of 16 symptoms from the General Symptom Distress Scale, and the total number of symptoms. Self-reported comorbid conditions were measured using the Bayliss tool. General linear models were used to relate symptom measures (one at a time) to age, number of comorbid conditions, level of education, marital status, income meeting needs, and size of metropolitan neighborhood. Additional covariates included site of cancer, its treatment, and whether the cancer was metastatic.
Non-Hispanic White survivors ( n = 191) were older and had more comorbid conditions, a higher proportion of metastatic cancers, and higher levels of education and income compared with Hispanic survivors ( n = 168) and non-Hispanic survivors of other races ( n = 41). Compared with the other two groups, Hispanic survivors had the lowest rate of health insurance availability, and non-Hispanic survivors of other races had the lowest social isolation. Age, number of comorbid conditions, and social isolation were significantly associated with number of symptoms, symptom severity, and depression. Age and social isolation were associated with anxiety. In addition, the symptom severity of non-Hispanic White survivors was lower than that of Hispanic survivors and non-Hispanic survivors of other races.
These findings highlight the health disparities in symptom burden experienced among cancer survivors when considering their social determinants of health. Assessing these may help clinicians address health disparities in cancer care.
Abstract
Background
Evidence-based interventions that optimize physical function for disabled and older adults living in the community who have difficulty with daily living tasks are available. ...However, uptake has been limited, particularly in resource-constrained (Medicaid) settings. Facilitation may be an effective implementation strategy. This study’s aim was to compare internal facilitation (IF) versus IF and external facilitation (EF) on adoption and sustainability of an intervention in a Medicaid home and community-based waiver.
Methods
In a hybrid type 3 trial, waiver sites (
N
= 18) were randomly assigned to implement the intervention using a bundle of strategies with either IF or IF and EF. Adoption and sustainability were assessed via Stages of Implementation Completion (SIC) for each site. Clinician attitudes toward evidence-based practice and self-efficacy were evaluated among 539 registered nurses, social workers, and occupational therapists. Medicaid beneficiary outcomes of activities of daily living, depression, pain, falls, emergency department visits, and hospitalizations were evaluated in a sample of
N
= 7030 as reflected by electronic health records data of the Medicaid waiver program. Linear mixed-effects models were used to compare outcomes between trial arms while accounting for cluster-randomized design.
Results
The mean SIC scores were 72.22 (standard deviation SD = 16.98) in the IF arm (9 sites) and 61.33 (
SD
= 19.29) in the IF + EF arm (9 sites). The difference was not statistically significant but corresponded to the medium clinically important effect size Cohen’s
d
= 0.60. Clinician implementation outcomes of attitudes and self-efficacy did not differ by trial arm. Beneficiary depression was reduced significantly in the IF + EF arm compared to the IF arm (
p
= .04, 95% confidence interval for the difference 0.01, 0.24). No differences between trial arms were found for other beneficiary outcomes.
Conclusions
Level of facilitation did not enhance capacity for adoption and sustainability of an evidence-based intervention in a Medicaid setting that cares for disabled and older adults. Improved beneficiary depression favored use of IF and EF compared to IF alone, and no differences were found for other outcomes. These findings also suggest level of facilitation may not have impacted beneficiary outcomes.
Trial registration
ClinicalTrials.gov
,
NCT03634033
; date registered August 16, 2018.
BACKGROUNDThe Long-Term Quality of Life (LTQL) instrument was designed for female cancer survivors who have completed treatment and includes an existential spirituality subscale that is omitted in ...many other quality of life scales. Women with advanced breast cancer are now living longer, while also expressing greater spiritual concerns.
OBJECTIVEThe objective of this analysis was to test the psychometric properties of the LTQL among women undergoing treatment of advanced breast cancer.
METHODSThis secondary analysis was based on a sample of 385 women. Validity was evaluated using a confirmatory factor analysis and associations with Functional Assessment of Cancer Therapy-Breast Cancer. Internal consistency reliability was assessed using Cronbachʼs α for each subscale of the LTQL.
RESULTSThe mean age was 56 years, 84% of participants were white, and 69% had metastasis. Model fit indices for the confirmatory factor analysis were acceptable, with the root mean square error of approximation of 0.076 (90% confidence interval, 0.071–0.081) and a comparative fit index of 0.91. The LTQL subscale scores were significantly correlated with the subscales of the Functional Assessment of Cancer Therapy-Breast Cancer of similar conceptual content. Internal consistency reliability for the subscales ranged from 0.80 to 0.86.
CONCLUSIONSThe factor structure of the LTQL was consistent with previous findings in long-term female cancer survivors. The instrument has adequate psychometric properties for use among women with advanced breast cancer.
IMPLICATIONS FOR PRACTICEThe LTQL can be used to assess the physical, psychosocial, and existential spiritual domains of quality of life among women with advanced breast cancer as well as in long-term female cancer survivors.
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