Gravis, G., Protiere, C., Eisinger, F., Boher, J.M., Tarpin, C., Coso, D., . . . Viens, P. (2011). Full access to medical records does not modify anxiety in cancer patients: Results of a randomized study. Cancer, 117, 4796–4804.
To assess the effect of providing systematic full access to the medical record on patients’ anxiety, quality of life, and satisfaction
Participants were randomly assigned to either requested access to the medical record or systematic full access groups. In the requested access group, information and the medical record were delivered to the patient at the physician’s or patient’s request. In the systematic access group, patients were given a briefcase that they were to bring to each visit. The briefcase was filled with administrative data as well as reports of surgery, pathology, laboratory, radiology, and hospitalizations and nursing narrative notes. Documents were provided to the patient as well as on CDs, including radiology images. Documents were updated at each visit, and in between visits materials were mailed to the patient. A coordinator provided updated information for the patient to put in the briefcase and explained the material to the patient in a standardized way. Medical and nursing staff also provided information and answered patient questions. Patients completed questionnaires for the study data collection at the beginning of the study and at the end of their first chemotherapy cycle.
Patients were undergoing the active treatment phase of care.
The study was a randomized controlled trial with repeated measures.
Mean anxiety score at baseline was 40.7 in all patients (scores of 20–80 generally indicate a higher level of anxiety). There were no differences at baseline between groups and no change over time in the systematic full access group. There was a significant reduction in anxiety at the end of treatment in the requested access group (p = 0.009), but no differences between study groups. There were no differences between groups in quality-of-life findings. A higher percentage of patients in the full access group were completely satisfied with treatment explanations than in the requested access group; however, the difference between groups was not significant. Full access was not a source of anxiety for 68.8% of patients, and 82.2% said they understood the information.
Provision of full information in an organized medical record provided to patients did not increase patient anxiety, was practical to implement, and may have a positive effect on patient satisfaction with information.
This study outlines a practical way to provide full medical record information to patients in a way that was acceptable to them. Findings show that provision of full information did not increase patient anxiety and was associated with a tendency for patients to have more satisfaction with information provision. This may be a useful approach to engage patients in their care. Most of these patients were fairly well-educated, so it is not clear whether these results can be generalized to less educated patients.
Granzow, J.W., Soderberg, J.M., Kaji, A.H., & Dauphine, C. (2014). An effective system of surgical treatment of lymphedema. Annals of Surgical Oncology, 21, 1189–1194.
To review the effectiveness and safety outcomes of patients selected to receive surgical procedure for lymphedema (LE) after a program of complete decongestive therapy (CDT)
LE therapy consisted of manual lymph drainage, compression bandaging and garments, and vascularized lymph node transfer (VLNT), which was used for upper extremity LE by removing lymph nodes from the groin and transferring them to the affected axilla or along with a deep inferior epigastric perforator (DIEP) flap. Lymphaticovenous anastomosis (LVA) was preferred for lower extremity LE, which was completed by connecting lymphatics to nearby microscopic veins. Both VLNT and LVA are for LE with primarily fluid component. Suction-assisted protein lipectomy (SAPL) is used to treat the solid type of LE and requires continued compression after procedure.
Retrospective chart review
The retrospective chart review of 26 selected patients from one surgeon identifying phases of LE, earlier with fluid component swelling, using VLNT, LVA, or SAPL showed positive results in regard to volume reduction, decreased infection episodes, and decreased garment/CDT requirements.
Gramignano, G., Lusso, M. R., Madeddu, C., Massa, E., Serpe, R., Deiana, L., . . . Mantovani, G. (2006). Efficacy of l-carnitine administration on fatigue, nutritional status, oxidative stress, and related quality of life in 12 advanced cancer patients undergoing anticancer therapy. Nutrition, 22, 136–145.
Carnitine is a cofactor required for cell energy production that serves as the primary fuel source for heart and skeletal muscles. Cancer-related anorexia/cachexia syndrome (CACS) and oxidative stress (OS) are two prominent features in patients with advanced cancer; therefore, L-carnitine supplementation was tested in patients with advanced cancer. Based on the current knowledge of carnitine use, patients took three doses (2 g) of L-carnitine orally each day for four weeks. Patient outcomes were evaluated at baseline (T0), week two (T1), and week four (T2).
Patients were undergoing the active treatment phase of care.
The study was an open-label, nonrandomized trial.
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
The L-carnitine intervention resulted in improved fatigue outcomes. The observed decline in MFSI-SF fatigue scores was statistically significance at both T1 (p < 0.05) and T2 (p < 0.001) in comparison to the baseline scores. Mean MFSI-SF scores at T0, T1, and T2 were 25.40 (standard deviation [SD] = 13.91), 16.93 (SD = 11.92), and 12.05 (SD = 12.56), respectively. Evaluation of subscales showed a statistically significant difference from T0 to T1 for the General subscale (p < 0.05) and the Physical subscale (p < 0.05).
Gralla, R., Bosnjak, S., Hontsa, A., Balser, C., Rizzi, G., Rossi, G., ... Jordan, K. (2014). A Phase 3 study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy. Annals of Oncology, 25(7), 1333–1339.
To assess the safety and evaluate the efficacy of a fixed-dose combination of netupitant and palonosetron (NEPA) over multiple cycles of highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC)
Oral NEPA (netupitant [NETU] 300 mg + palonosetron [PALO] 0.50 mg) + dexamethasone (DEX) versus oral aprepitant (APR) (125 mg Day 1; 80 mg Days 2–3) + oral PALO 0.50 mg Day 1 + DEX (for HEC, DEX Days 1–4; for MEC, DEX Day 1 only)
Phase 3 multinational, double-blind, double-dummy, parallel group study design
Graham, P., Browne, L., Capp, A., Fox, C., Graham, J., Hollis, J., & Nasser, E. (2004). Randomized, paired comparison of no-sting barrier film versus sorbolene cream (10%
glycerine) skin care during post mastectomy irradiation. International Journal of Radiation Oncology, Biology, Physics, 58, 241–246.
To test the effect of prophylactic 3M Cavilon no-sting barrier film (no-sting) on the rates of moist desquamation compared with sorbolene cream (10% glycerin).
The chest wall was divided into medial and lateral halves, with one half treated with no-sting and the other with sorbolene. No-sting was applied by the nursing staff. Administration began at the start of radiation therapy until two weeks after completion. When a moist desquamation occured, the skin care changed to hydrocolloid dressing.
The study took place across multiple sites in Sydney, Australia.
The study used a quasi-experimental design with patients as their own control.
No-sting may be beneficial in the mitigation of skin toxicity with radiation therapy.
Graham, P.H., Plant, N., Graham, J.L., Browne, L., Borg, M., Capp, A., . . . Zissiadis, Y. (2013). A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: Trans Tasman Radiation Oncology Group (TROG) 04.01. International Journal of Radiation Oncology, Biology, Physics, 86, 45–50.
A previous unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine (sorbolene) cream. The different appearances of these products precluded a blinded comparison. To test the ATP principle in a double-blind manner required use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC). This study tested the hypothesis that an ATP alcohol-free barrier film reduces the degree of radiation skin reaction compared with the 10% glycerine cream most commonly used for this purpose in women receiving postmastectomy radiation therapy in Australia.
The chest wall was divided into medial and lateral compartments, and patients were randomized to receive MDBC applied daily to the medial or lateral side and sorbolene to the other side. Patients were instructed to apply the separate creams daily at the start of radiation to each half of the area on the chest wall receiving radiation therapy and to continue until two weeks after radiation completion. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected until week 12, or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters (TLDs).
The MDBC did not reduce peak skin reaction compared to sorbolene. It is possible that this is related to the difference in formulation of the cream compared with film formulation.
This study emphasizes the requirement for well-designed, appropriately powered, and controlled studies for skin care products. This study also potentially emphasizes that skin care products can vary in effectiveness based on formulation.
Graham, P.H. (2002). Compression prophylaxis may increase the potential for flight-associated lymphoedema after breast cancer treatment. Breast, 11 (1), 66–71.
Researchers conducted a survey to elicit information that would aid in the evaluation of the potential connection between flying and lymphedema. The study reported on 287 women with relapse-free breast cancer with known pathology/treatment and prospectively measured arm circumferences. Patient and treatment factors were age, type of surgery, number of nodes sampled and number positive, and radiotherapy technique.
Subjects were surveyed by phone and mail regarding flight history, precautions taken, and incidences of arm swelling subsequent to flying.
Gradalski, T., Ochalek, K., & Kurpiewska, J. (2015). Complex decongestive lymphatic therapy with or without Vodder II manual lymph drainage in more severe chronic postmastectomy upper limb lymphedema: A randomized non-inferiority prospective study. Journal of Pain and Symptom Management, 50, 750–757.
To compare the effects of compression bandaging and physical exercises versus the same management augmented by an additional 30 minutes of manual lymph drainage
Sixty women post mastectomy were randomly assigned to either a compression bandage group or a manual lymph drainage group. Fifty-one women then completed two weeks of intensive therapy and six months of maintenance therapy (26 weeks total).
Summed truncated cone method was used to measures limb segment volume. Limb relative volume change (RVC) was measured using the formula treatment (SLafter treatmentNLbefore)/(NLafter SLbefore), where SL is swollen limb volume and NL is normal limb volume. Edema-related quality of life was measured using the Lymphedema Questionnaire.
In both groups, a significant reduction in SL volume, LE volume, and RVC occurred after each day of the first week of therapy. Within the two-week intensive phase, a significant decrease in SL and LE volumes occured (p < 0.001). A rebound effect occurred in the CB-G group within the first month, but after six months, the SL and LE volumes in both groups were not statistically significant. Six months after finishing intensive therapy, no significant difference in lymph volumes existed between the two groups (p = 0.3).
Patients with postmastectomy LE may have a similar benefit of CDT without MLD on limb edema reduction. Compression bandaging combined with physical exercise may be considered a basic treatment option in limb LE.
The results of this study may help guide overall treatment in women post mastectomy with breast cancer–related lymphedema. However, the effect of manual lymph drainage remains unexplored because immediate lymph fluid draining images and long-term lymphatic changes were not investigated.
Gouvea de Lima, A., Villar, R.C., de Castro, G., Jr., Antequera, R., Gil, E., Rosalmeida, M.C., … Snitcovsky, I.M.L. (2012). Oral mucositis prevention by low-level laser therapy in head-and-neck cancer patients undergoing concurrent chemoradiotherapy: A phase III randomized study. International Journal of Radiation Oncology, Biology, Physics, 82, 270–275.
To evaluate the efficacy of low-level laser therapy (LLLT) to decrease severe oral mucositis and reduce radiation therapy (RT) interruptions
Patients received either gallium aluminum arsenide LLLT 2.5 J/cm2 or placebo laser before each radiation fraction.
This was a single-site, outpatient study conducted in Brazil.
Patients were undergoing the active treatment phase of care.
This was a randomized, double-blind, phase III study.
LLLT benefit was limited to fewer interruptions in RT.
LLLT dosage, schedule, specific laser type, and availability all need to be addressed.
Gøtzsche, P.C., & Johansen, H.K. (2014). Nystatin prophylaxis and treatment in severely immunodepressed patients. Cochrane Database of Systematic Reviews, 9, CD002033.
STUDY PURPOSE: To determine if nystatin prophylaxis or treatment for fungal infection decreases morbidity and mortality in immunocompromised patients
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Active antitumor treatment
Nystatin cannot be recommended for prophylaxis or the treatment of Candida infections in immunodepressed patients.
Nystatin is no more effective than placebo for the prevention or treatment of fungal infections in immunocompromised patients.