Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial.

PURPOSE: To conduct a secondary analysis focused on health-related quality of life (HRQOL) among caregivers engaged in a 12-week complementary therapy sequential multiple assignment randomized trial (SMART) of reflexology and/or meditative practices (MP), to manage cancer patients' symptoms. METHODS: In this SMART, patient-caregiver dyads were initially randomized to 4 weeks of caregiver-delivered reflexology for the patient (N = 150), MP with the patient (N = 150), or control (N = 47). After 4 weeks, dyads with patients not improving on fatigue (non-responders, n = 69 to reflexology and n = 57 to MP) were re-randomized to continue the same therapy or add the other therapy for an additional 4 weeks. Week-12 caregiver HRQOL was measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 and the Caregiver Reaction Assessment Tool (CRAT) for caregiver burden; scores were analyzed using general linear models. RESULTS: In the comparison of 4 adaptive intervention sequences: reflexology for 8 weeks, reflexology for 4 weeks followed by MP for 4 weeks if no response to reflexology, MP for 8 weeks, and MP for 4 weeks followed by reflexology for 4 weeks if no response to MP, there were no differences in PROMIS-29 scores. However, CRAT domains of impact on schedule, family support, and finances worsened when adding reflexology after the first 4 weeks of MP. The CRAT domain of health worsened by adding either intervention compared to continuing the same one. CONCLUSIONS: Clinicians should be aware that caregiver engagement in more than one complementary therapy may increase caregiver burden in some domains but not affect other HRQOL domains. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02759146.

Reflexology and meditative practices for symptom management among people with cancer: Results from a sequential multiple assignment randomized trial.

Optimal sequencing of complementary therapies can help improve symptom management through nonpharmacological approaches. A 12-week sequential multiple assignment randomized trial comparing home-based reflexology and meditative practices on severity of fatigue and other symptoms was conducted among patients with cancer and their informal caregivers. Dyads were initially randomized to reflexology (N = 150), meditative practices (N = 150), or control (N = 47). If patient's fatigue did not improve (nonresponse) after 4 weeks of reflexology or meditative practices, the dyad was rerandomized to either add the other therapy or continue with the original therapy for weeks 5-8. Four decision rules (DRs) were compared: (1) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, continue with reflexology for another 4 weeks, thus providing a higher dose; (2) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, add meditative practices for the next 4 weeks; (3) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, continue meditative practices for another 4 weeks, thus providing a higher dose; and (4) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, add reflexology for the next 4 weeks. Symptoms were evaluated weekly using the M.D. Anderson Symptom Inventory (MDASI). Clinically, nurses can recommend either therapy since no differences were found among the 4 DRs, with the exception of lower severity for summed MDASI symptoms at week 8 for the use of reflexology only (DR-1) versus DR-2 (sequencing reflexology to meditative practices). Adding the other therapy for nonresponders after 4 weeks may not be warranted.

Effect of a multi-modal intervention on immunization rates in obstetrics and gynecology clinics.

BACKGROUND: There is increasing attention on immunizations by obstetrician-gynecologists and a need to improve vaccination rates for all women. OBJECTIVE: To evaluate the effect of a multimodal intervention on rates of immunization with tetanus, diphtheria, and acellular pertussis (Tdap); human papillomavirus (HPV); and influenza in outpatient obstetrics and gynecology clinics. STUDY DESIGN: Immunization rates at 2 clinics were compared pre- and post-implementation of multiple interventions at a public integrated health-care system. Study interventions began on June 6, 2012 and concluded on May 31, 2014; the preimplementation time period used was June 6, 2010 to June 5, 2012. Interventions included stocking of immunizations in clinics, revision and expansion of standing orders, creation of a reminder/recall program, identification of an immunization champion to give direct provider feedback, expansion of a payment assistance program, and staff education. All women aged 15 and older who made a clinic visit during influenza season were included in the influenza cohort; women who delivered an infant during the study time period and had at least 1 prenatal visit within 9 months preceding delivery were included in the Tdap cohort; each clinic visit by a nonpregnant woman aged 15-26 years was assessed and included in the HPV analysis as an eligible visit if the patient was lacking any of the 3 HPV vaccines in the series. The primary outcome was receipt of influenza and Tdap vaccine per current American College of Obstetricians and Gynecologists guidelines and receipt of HPV vaccine during eligible visits. Influenza and Tdap were assessed with overall coverage rates at the institutional level, and HPV was assessed at the visit level by captured opportunities. All analyses included generalized estimating equations and the primary outcome was assessed with time as a covariate in all models. RESULTS: A total of 19,409 observations were included in the influenza cohort (10,231 pre- and 9178 post-intervention), 2741 in the Tdap cohort (1248 pre- and 1493 post-intervention), and 12,443 in the HPV cohort (7966 pre- and 4477 post-intervention). Our population was largely Hispanic, English-speaking, and publicly insured. The rate of influenza vaccination increased from 35.4% pre-intervention to 46.0% post-intervention (P < .001). The overall rate for Tdap vaccination increased from 87.6% pre-intervention to 94.5% post-intervention until the recommendation to vaccinate during each pregnancy was implemented (z = 4.58, P < .0001). The average Tdap up-to-date rate after that recommendation was 75.0% (z = -5.77, P < .0001). The overall rate of HPV vaccination with an eligible visit increased from 7.1% before to 23.7% after the intervention. CONCLUSION: Using evidence-based practices largely established in other settings, our intervention was associated with increased rates of influenza, Tdap, and HPV vaccination in outpatient underserved obstetrics and gynecology clinics. Integrating such evidence-based practices into routine obstetrics and gynecology care could positively impact preventive health for many women.