develop and test Web-based systems that are accessible by both patients and their care providers.

Several types of research study designs may be applied to these various questions. Qualitative research, such as focus groups and interviews, can identify potential barriers to implementation and strategies to overcome them. Observational studies, such as cross-sectional surveys of patients, may be instructive to assess knowledge, needs, and gaps in care delivery. Answers to some questions pertaining to surveillance patterns may be ascertained through medical record review or analyses of administrative data. Prospective cohort studies may also be informative. For example, a cohort study that included a baseline measurement of knowledge, anxiety, or other outcome of interest and then provided patients with all or part of the Survivorship Care Plan could help determine how that variation in plan content affects outcome.

Quasi-experimental studies, in which the experience before and after administering care planning is assessed, could be informative. There may also be some natural experiments in which comparisons could be made between clinics that, for example, implemented just the treatment summary and those that implemented both the treatment summary and the care plan.

Finally, randomized controlled trials could be conducted on aspects of patient follow-up. Such trials are expensive and logistically difficult, but they are very informative. Eva Grunfeld is an investigator who has completed several trials on alternative follow-up strategies for women with breast cancer.2 Clinical trials would provide the best evidence on how outcomes are affected by survivorship care planning. For the questions pertaining to economic resource utilization, trials may be the only mechanism to obtain good estimates. One of the challenges to conducting randomized trials will be contamination. If randomization occurs at the level of a patient, a physician who is providing care planning to some patients and not to others is probably going to improve the survivorship care planning that they do with all patients. Because the IOM and other groups have recommended survivorship care planning, there may also be ethical issues if some patients are randomized to a group that does not receive care plans.

2

Grunfeld E. et al., 2006. Randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care. Journal of Clinical Oncology 24(6):848-55. Grunfeld E. et al., 1999. Comparison of breast cancer patient satisfaction with follow-up in primary care versus specialist care: Results from a randomized controlled trial. British Journal of General Practice 49(446):705-710. Grunfeld E. et al., 1999. Follow-up of breast cancer in primary care vs specialist care: Results of an ecomonic evaluation. British Journal of General Practice 79(7-8):1227-1233. Grunfeld E. et al., 1995. Evaluating primary care follow-up of breast cancer: Methods and preliminary results of three studies. Annals of Oncology 6(Suppl 2):47-52.



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