Well-Being Therapy and Lifestyle Intervention in Type 2 Diabetes: A Pilot Randomized Controlled Trial.

OBJECTIVE: This pilot randomized controlled trial evaluates the preliminary efficacy of a 4-month well-being therapy (WBT) and lifestyle intervention among adults with type 2 diabetes and overweight/obesity. METHODS: Fifty-eight patients were recruited from two outpatient clinics and randomized to receive the WBT-lifestyle intervention or the lifestyle intervention alone. Data were collected at baseline (T0), immediate postintervention (T1), 6-month follow-up (T2), and 12-month follow-up (T3). Primary efficacy outcomes included changes in weight, psychological distress, and well-being, whereas secondary efficacy outcomes included changes in lifestyle and physiological parameters. RESULTS: Compared with the lifestyle-alone intervention, the WBT-lifestyle intervention showed greater improvements in depression (p = .009, d = -0.6), hostility (p = .018, d = -0.6), and personal growth (p = .026, d = 0.5) at T1, in self-reported physical activity at T2 (p = .013, d = 0.7) and T3 (p = .040, d = 0.5), and in triglycerides (p = .019, d = -1.12) at T3. There were no differences between treatment groups in weight and other physiological parameters. CONCLUSIONS: These findings suggest that WBT may be a valuable addition to lifestyle interventions for improving short-term psychological outcomes and promoting long-term healthy changes in physical activity, with a potential impact on physiological outcomes.Trial Registration:ClinicalTrials.gov identifier: NCT03609463.

A reporting system for the assessment of chemotherapy toxicity.

PURPOSE: Toxicity may distress patients and cause delay or a discontinuance of scheduled chemotherapies. A key issue is to create a reporting system in order to assess toxicities and also evaluate treatments. METHODS: In the Oncology Unit 3,000 intravenous chemotherapies are administered each year, mostly in the day hospital. In summer 2002, oncologists and pharmacists agreed to assess myelosuppression and gastrointestinal toxicity of grades 3 and 4. Pharmacists designed a form and a database in order to collect toxicity data for every patient. The oncologist records type and grade of toxicity (according to the NCI CTC) on the patient chart before chemotherapy commences. During the validation of computerized prescriptions the pharmacist collects data about possible toxicities of every grade. RESULTS: From August-October 2002, 675 chemotherapies were administered. Seventy-two patients developed GI toxicity at various grades, nine of grade 3 and two of grade 4. Regimens with fluorouracil, carboplatin, cisplatin and oxaliplatin were highly involved in GI toxicity. Eighty-seven patients developed myelosuppression, two of grade 3 and 33 of grade 4. Regimens with epirubicin, cyclophosphamide, paclitaxel, cisplatin and carboplatin were highly involved in myelosuppression. After the first report, oncologists and pharmacists decided to stop collecting data in order to improve the reporting system and to plan regular meetings. CONCLUSIONS: A reliable reporting system is a valuable tool for oncologists to manage toxicity and to evaluate chemotherapy regimens. Assessing chemotherapy toxicity is a good opportunity for pharmacists to take part in preventing toxicity and reducing patient's discomfort.