Clinical and Cost-effectiveness of a Comprehensive geriatric assessment and management for Canadian elders with Cancer-the 5C study: a study protocol for a randomised controlled phase III trial.

INTRODUCTION: Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting. TRIAL DESIGN: A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation. PARTICIPANTS: A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0-2 will be recruited. All participants will be followed for 12 months. INTERVENTION: Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months. OBJECTIVE: To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care. RANDOMISATION: Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other). OUTCOME: Quality of life. SECONDARY OUTCOMES: (1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3-5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival. PLANNED ANALYSIS: For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2-4, we will use a variety of methods. ETHICS AND DISSEMINATION: Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings. TRIAL REGISTRATION NUMBER: NCT03154671.

Emergency contraception use is correlated with increased condom use among adolescents: results from Mexico.

PURPOSE: To evaluate the association between knowledge about, or experience with, emergency contraception (EC), and condom use among school-attending adolescents in the state of Morelos, Mexico. METHODS: We analyzed data from anonymously self-administered questionnaires (n = 10,918), from a cluster-randomized controlled trial among first year students from 40 (75%) public high schools in Morelos, Mexico. The survey included specific questions about EC knowledge and experience as well as questions about perceived ability to negotiate and condition sexual relations on condom use; and condom use at first and last sexual intercourse. RESULTS: Overall, 61% (6384) of students had heard of EC, and 36% (1964) of girls and 39% (1997) of boys had correct knowledge about EC. Correct knowledge was based upon knowing that EC is pills taken up to 3 days after unprotected sex to prevent pregnancy. Of 1695 (15.6%) reporting lifetime sexual activity, 16.4 % (275) reported they had tried to obtain EC and almost of all them (263) reported having used EC. The probability of a student reporting he/she is capable of interrupting sexual intercourse to use a condom was significantly higher for those who had correct EC knowledge, and a history of EC use was strongly correlated with condom use at last sexual intercourse. CONCLUSIONS: Experience with emergency contraception has no adverse effects on condom use, but rather is associated with an increased probability of condom use and an increased perceived capacity to negotiate condom use. Despite concern that information about, and access to EC may encourage sexual risk taking, our results suggest the reverse is true. These data support the position that there is no justification to withhold EC information or access from adolescents.