Dose-finding designs for trials of molecularly targeted agents and immunotherapies.

Recently, there has been a surge of early phase trials of molecularly targeted agents (MTAs) and immunotherapies. These new therapies have different toxicity profiles compared to cytotoxic therapies. MTAs can benefit from new trial designs that allow inclusion of low-grade toxicities, late-onset toxicities, addition of an efficacy endpoint, and flexibility in the specification of a target toxicity probability. To study the degree of adoption of these methods, we conducted a Web of Science search of articles published between 2008 and 2014 that describe phase 1 oncology trials. Trials were categorized based on the dose-finding design used and the type of drug studied. Out of 1,712 dose-finding trials that met our criteria, 1,591 (92.9%) utilized a rule-based design, and 92 (5.4%; range 2.3% in 2009 to 9.7% in 2014) utilized a model-based or novel design. Over half of the trials tested an MTA or immunotherapy. Among the MTA and immunotherapy trials, 5.8% used model-based methods, compared to 3.9% and 8.3% of the chemotherapy or radiotherapy trials, respectively. While the percentage of trials using novel dose-finding designs has tripled since 2007, the adoption of these designs continues to remain low.

Associations Between Decisional Balance and Health Behaviors Among Adult Cancer Survivors.

Interventions directed at health behavior change are increasingly being developed for cancer survivors. This study validates decisional balance measures for physical activity and fruit and vegetable (F/V) consumption among adult survivorship population. Participants were N = 86 patients who previously completed primary treatment for breast or prostate cancer for at least 5 years and were enrolled in an e-health intervention that aimed to improve physical activity and nutrition behaviors. Decisional balance, stage of change, F/V consumption, and physical activity were assessed at baseline and 3 months. Factor analysis was used to assess the structure of the decisional balance measures. The relationship between decisional balance, stage, and behavioral outcomes was assessed with mixed model analyses. The two factor structures of each measure were supported. Pros and cons differed across stages of change for both behaviors (p's < .0001). Total Metabolic Equivalent of Task units (METs) were related to decisional balance pros (p = .012) and cons (p = .003). F/V consumption was significantly associated with decisional balance pros (p = .0003), but not cons (p = .112). Overall, findings provide validation for these decisional balance measures as indicators of health behaviors and support the value of using these measures in further research to aid in understanding of behavior change in this population.

An eHealth Intervention to Increase Physical Activity and Healthy Eating in Older Adult Cancer Survivors: Summative Evaluation Results.

BACKGROUND: A healthy lifestyle is associated with improved quality of life among cancer survivors, yet adherence to health behavior recommendations is low. OBJECTIVE: This pilot trial developed and tested the feasibility of a tailored eHealth program to increase fruit and vegetable consumption and physical activity among older, long-term cancer survivors. METHODS: American Cancer Society (ACS) guidelines for cancer survivors were translated into an interactive, tailored health behavior program on the basis of Social Cognitive Theory. Patients (N=86) with a history of breast (n=83) or prostate cancer (n=3) and less than 5 years from active treatment were randomized 1:1 to receive either provider advice, brief counseling, and the eHealth program (intervention) or advice and counseling alone (control). Primary outcomes were self-reported fruit and vegetable intake and physical activity. RESULTS: About half (52.7%, 86/163) of the eligible patients consented to participate. The most common refusal reasons were lack of perceived time for the study (32/163) and lack of interest in changing health behaviors (29/163). Furthermore, 72% (23/32) of the intervention group reported using the program and most would recommend it to others (56%, 14/25). Qualitative results indicated that the intervention was highly acceptable for survivors. For behavioral outcomes, the intervention group reported increased fruit and vegetable consumption. Self-reported physical activity declined in both groups. CONCLUSIONS: The brief intervention showed promising results for increasing fruit and vegetable intake. Results and participant feedback suggest that providing the intervention in a mobile format with greater frequency of contact and more indepth information would strengthen treatment effects.