Risks and benefits must be weighed in the decision making process. I presently have none of the risk factors associated with breast cancer: family history, early menarche, oral contraceptive use, benign breast disease, late age at first childbirth, obesity, alcohol use. Although, I do have ionizing radiation exposure risk due to the fact my of my employment as a radiation therapist, my levels have been monitored and kept within the radiation worker guidelines. Some studies also suggest that another risk factor maybe height. Tallness is associated with an increased risk of breast cancer with a typical relative risk of 1.3-1.4 depending on age. I definitely don’t have this risk (I’m only 5’2”). Other risk factors studied include age at menopause and post menopausal hormone replacement therapy. I have not yet reached these milestones in my life.
There may be unpleasant, serious or even life threatening side effects from participating in the protocol. In the dietary study, I cannot foresee any side effects from reducing my fat intake. The length of the study is too long for me although a lifelong change in eating habits may be beneficial to my health (excluding the breast cancer prevention aspect). In the drug study, I have concerns regarding the risks involved in taking such a drug. Acute side effects such as hot flashes and dry vagina are not worrying. The potential to induce endometrial cancer, osteoporosis, arteriosclerosis, thromboembolic disorders, liver carcinogensis, ovarian stimulation, teratogenesis and ophthalmic effects are of concern.
Compliance of a study is crucial to the study outcome. I would have difficulty with compliance in the tamoxifen study. I am forgetful in taking prescription drugs once the symptoms have subsided. As there are no symptoms, I can foresee I would forget to take medicine/pills frequently. I also find that I’m too busy to remember to take them at the appropriate time. Compliance in changing dietary habits is just as difficult of me but, if a food schedule is laid out, I can follow it easily.
In order to participate in a study a person needs to have a level of comfort/ trust/confidence in the study and it’s investigators. Accompanying pamphlets are made to increase these levels by giving information to the patient in layman’s terms. The pamphlet associated with the diet study accomplishes this by acknowledging crucial elements: the patient is free to leave the study at any time; selling the idea of why the study must continue for 10 years; why contact is so important; stating why it is important that one doesn’t drop out reducing the scientific value of the study results. But in comparing the protocol and the brochure, I find discrepancies that reduce my level of trust. A perceived discrepancy such as one with the schema reduces the confidence level that I have in the investigator. The protocol schema states group one will have 36% of calories from fat and group two 15% calories from fat while the pamphlet states group one women continue on their normal diet while group two intake will be high carbohydrate/low fat. As for the drug study, I do have a level of trust and comfort in the investigators from reading the study but, I don’t trust using a drug on an otherwise healthy adult with basically no associated risk factors. All the patient monitoring done for this study does impress me though, building my level of comfort and trust.
The primary hypothesis of the study arm of these two studies is to prevent the occurrence and reduce the mortality of breast cancer. In either study, I may not get the study arm and therefore any arguments regarding the drug or diet would be moot. Then bottom line is I am not comfortable with either study given the information I have. Although, I would not participate in one of these two studies, I do believe in research and would participate in a well designed and well executed study in order to play an active role in my own health care, gain access to new research treatments, obtain frequent expert medical care and, help others by contributing to medical research.
