Table 1.

Study Characteristics

Protocol	Description	Projected Patients/Actual Accrual	Site Specify	Assessment Schedule
MC0915	Phase I Open Label, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetic Properties of the Combination of Cilengitide and Paclitaxel in Patients with Advanced Malignancies	32/12	Breast	3 booklets per patient: completed during cycle 1
MC0995	PAL-2: A Pilot Study of the Palliative ARNP (Advanced Registered Nurse Practitioner) Liaison Program (The PAL Program) Intended to Improve Patients' Quality of Life Through Targeted FACT-G Driven Palliative Interventions	25/14	Lymph nodes and bone marrow	2 booklets per patient: 1 at baseline and 1 at 28 days post enrollment.
MC09C4	Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes	45/43	N/A	1 booklet per patient: hot flash diary completed daily and PROs completed weekly for 7 weeks
MC10C9	Phase II Randomized Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress	40/25	Colorectal	3 booklets per patient: 1 at baseline, 1 weekly for 4 weeks during treatment, and 1 weekly for 4 weeks during observation
MC11C4	A Pilot Randomized, Placebo-Controlled, Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy	50/44	Colorectal	Multiple booklets per patient: 1 daily for the first 6 days of every week cycle of treatment followed by 5 post-treatment
N07C4	Phase II Randomized Trial Evaluating Two Non- pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-Wake Disturbances	168/81	N/A	2 booklets per patient: 1 daily during week 1 and one daily during weeks 2–7
N08C9	Phase III Randomized Study of Sulfasalazine versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy	140/84	Endometrial	5 booklets per patient: 1 at baseline, 1 weekly during treatment, 1 weekly for 6 weeks post treatment, and 2 during observation
N08CB	Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity	354/352	Colorectal	Multiple booklets per patient: 1 daily for the first 6 days of every 2 week cycle of treatment followed by 5 post-treatment
N0949	Phase III Randomized Trial of mFOLFOX7 or XELOX Plus Bevacizumab Versus 5-Fluorouracil/Leucovorin or Capecitabine Plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer	380/31	Colorectal	Multiple booklets per patient: 1 prior to every treatment cycle, 1 every 3 months during treatment, and 1 during observation
N09C6	Phase III Randomized Double-Blind Study of Doxepin Rinse versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy with or without Chemotherapy	198/156	Head/Neck	Multiple booklets per patient: 2 on day 1, 2 on day 2, and 1 every week during optional continuation phase
N1031	Phase II Randomized Study of Two Doses of Pixantrone in Patients with Metastatic Breast Cancer	56/45	Breast	Multiple booklets per patient: 1 prior to every cycle of treatment, during observation
N10C1	Phase III Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo-Controlled Study	456/451	N/A	Up to 4 booklets per patient: 1 at baseline, 1 containing PROs to be completed at weeks 4, 6 and 8, 1 at week 12 and 1 at during continuation phase
N10C2	Phase III Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes	288/291	N/A	Up to 4 booklets per patient: 1 daily during baseline week, 1 daily during weeks 2–5, 1 daily during weeks 6–9, and 1 daily during 4 weeks of continuation phase
RC11C3	Pilot Placebo-Controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome	46/43	Breast	Multiple booklets per patient: 1 at baseline, 1 daily for every 1 week cycle of treatment followed by 5 post-treatment