additional types of clinical research in oncology

Question 1

types of clinical trials

Answer 1

way researchers behave
observational study aka natural experiment - invesigators observe subjects and measure their outcomes. researchers do not actively manage the experiment
example is Nurses’ health study
interventional study- investigators give research subjects a medicine or other intervention. compares treated subjjects to untreated subjects

Question 2

nurse’s health study

Answer 2

an observational cohort study of women with updated exposure assesment for broad range of lifestyle factors, endogenous hormones and DNA, in relation to risk of breast cancer.
investigated long term health consequences of oral contracpetive use
started as a questionniare

Question 3

study designs

Answer 3

observational studies= investigators only observe association btw treatments experienced by patients and their health status or disease. example= ppl with red hair get into program less
observational studies are cohort study and case-control study are less compelling evidence than randomized controlled trial
case control studies = can identify factors that may contribute to a condition by comparing subjects with that condition (the cases) w/pts who dont have condition but are otherwise similar (the controls)

Question 4

case control studies (an observational study)

Answer 4

comparison of ppl with condition (cases) and without (controls)
inexpensive
their retrospective and non randomized nature limits conclusions
used to find link btw tobacco smoking and lung cancer

Question 5

cohort studies (an observational study)

Answer 5

group who share common characteristics or experience within defined period and is a comparison group thought to have little or no exposure to substance investigated
its a longitudinal study b/c follow up with group over years and is expensive
NOT ppl who already have disease but instead you are looking for development of it
sensitive to attrition

Question 6

3 types of science

Answer 6

necessity
sufficiency
association

Question 7

findings from nurses health studies indicate

Answer 7

more than 50% of cancer cases can be prevented by adopting healthy lifestyle

Question 8

womens health study is

Answer 8

source of knowledge of estrogen associated risk factors for breast cancer

Question 9

ways of classifying trials is by

Answer 9

their purpose (interventional trials) like prevention trials, screening trials, diagnostic trials, treatment trials, quality of life trials, compassionate use trials,
also prevention trials
way researchers behave

Question 10

prevention trials

Answer 10

aim to prevent, arrest, or reverse either the initation phase of carcinogenesis or progression of premalignant cells

Question 11

who do you do prevention studies in?

Answer 11

ppl who are at high risk

Question 12

study of tamoxifen and raloxifene (STAR)

Answer 12

to compare raloxifen and tamoxifene in high risk postmenopausal women in a randomized double blind placebo trial
STAR assessed occurrence of noninvasive breast cancer, endometrial cancer, and cardiovasular events with potential side effects of raloxifeen and tamoxifen targeted as secondary endpoints

Question 13

raloxifene lead to less ____ than tamoxifene

Answer 13

cumulative incidence of invasive uterine cancer
thromboembolic events
cataracts

Question 14

screening trials

Answer 14

to catch cancer early and hopefully just cut it out

Question 15

basic criteria for screening

Answer 15

must be favorable for patient

Question 16

5 screening tests used b/c shown to increase survival

Answer 16

mammogram
papsmear
psa
hemoccult
spiral CT screening

Question 17

prevalence of disease matters on

Answer 17

how credible your results are

Question 18

1/10 is high prevelance in disease while 1/100

Answer 18

is less prevelant

Question 19

sensitivity=

Answer 19

percent of ppl with disease testing positive over total ppl tested for sensitivity

Question 20

specificity =

Answer 20

percent of ppl without disease testing negative over total ppl tested for specificity

Question 21

positive prediction value

Answer 21

% of ppl with + test who have disease

calculation: # of ppl tested + divided by total # of ppl tested + and -

Question 22

negative prediction value=

Answer 22

% of ppl with negative test who dont have disease

calculation: # of ppl tested - divided by total # of ppl tested + and -

Question 23

symptom managment trials have primary endpoints of

Answer 23

symptom relief

Question 24

treatment trials have primary endpoints

Answer 24

tumor response

survival and or progression free survival

Question 25

health related quality of life (HRQOL) 3 key challenges

Answer 25

1) must have strong rationales
2) models must delineate relation among symptoms, function, dimensions/domains with global quality of life
3) studies must pay attention to measurement issues and analytic strategies assesing HRQOL

Question 26

HRQOL

Answer 26

assessment in cancer symptom managment trials

Question 27

hormone replacement therapy

Answer 27

small significant benefit in health related quality of life related to sleep disturbance, physical functioning, and bodily pain

Question 28

participation of racial minorities and other underrepresented groups in clinical trials

Answer 28

is a critical link btw scientific innovation and improvement in healthcare delivery and health

Question 29

main patient barrier to clinical trial enrollment

Answer 29

mistrust of research

Question 30

main barrier to clinical trial awareness

Answer 30

education regarding clinical trials

Question 31

main barrier to clinical trial opportunity

Answer 31

provider attitudes

Question 32

main barrier to acceptance

Answer 32

mistrust

Question 33

selenim and vitamin E cancer prevention trial (SELECT)

Answer 33

SELECT =