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Can we demonstrate that breast cancer "integrative oncology" is effective? A methodology to evaluate the effectiveness of integrative oncology offered in community clinics.

ABSTRACT: Many women diagnosed with breast cancer receive both standard cancer treatment and care from providers trained in the emerging field of medicine called integrative oncology (IO) in which science-based complementary and alternative medical therapies are prescribed by physicians. The effectiveness of IO services has not been fully studied, so is yet unknown.Determine if a matched, case-controlled prospective outcomes study evaluating the efficacy and safety of breast cancer IO care is feasible.Methodological proof of principle requires demonstration that (1) it is possible to find matched control breast cancer patients using the Surveillance, Epidemiology and EndResults. A pilot study was conducted in 2008 (n = 14) to determine if matched controlled women could be identified in the western Washington SEER database. All 14 women who were approached agreed to participate. The cases were matched to the CSS along 5 variables: age and stage at diagnosis, race, and marital and Estrogen Receptors/Progesterone Receptors (ER/PR) status. Multiple matches were found for 12 of the 14 participants.A prospective cohort study with a matched comparison group is a feasible and potentially rigorousIt may provide valuable data for the evaluation of the effectiveness of IO care on patient health, relapse rate, and health-related quality of life (HRQOL). A federally funded matched case controlled outcomes study is currently under way at Bastyr University and the Fred Hutchinson Cancer Research Center.

SUBMITTER: Standish LJ

PROVIDER: S-EPMC4739815 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Can we demonstrate that breast cancer "integrative oncology" is effective? A methodology to evaluate the effectiveness of integrative oncology offered in community clinics.

Standish Leanna J LJ Sweet Erin E Naydis Eleonora E Andersen M Robyn MR

Integrative cancer therapies 20120627 2

<h4>Background</h4>Many women diagnosed with breast cancer receive both standard cancer treatment and care from providers trained in the emerging field of medicine called integrative oncology (IO) in which science-based complementary and alternative medical therapies are prescribed by physicians. The effectiveness of IO services has not been fully studied, so is yet unknown.<h4>Purpose</h4>Determine if a matched, case-controlled prospective outcomes study evaluating the efficacy and safety of br ...[more]

PMID: 22740079

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Project description:BackgroundDisseminating care guidelines into clinical practice remains challenging, partly due to inadequate evidence on how best to help clinics incorporate new guidelines into routine care. This is particularly true in safety net community health centers (CHCs).MethodsThis pragmatic comparative effectiveness trial used a parallel mixed methods design. Twenty-nine CHC clinics were randomized to receive increasingly intensive implementation support (implementation toolkit (arm 1); toolkit + in-person training + training webinars (arm 2); toolkit + training + webinars + offered practice facilitation (arm 3)) targeting uptake of electronic health record (EHR) tools focused on guideline-concordant cardioprotective prescribing for patients with diabetes. Outcomes were compared across study arms, to test whether increased support yielded additive improvements, and with 137 non-study CHCs that share the same EHR as the study clinics. Quantitative data from the CHCs' EHR were used to compare the magnitude of change in guideline-concordant ACE/ARB and statin prescribing, using adjusted Poisson regressions. Qualitative data collected using diverse methods (e.g., interviews, observations) identified factors influencing the quantitative outcomes.ResultsOutcomes at CHCs receiving higher-intensity support did not improve in an additive pattern. ACE/ARB prescribing did not improve in any CHC group. Statin prescribing improved overall and was significantly greater only in the arm 1 and arm 2 CHCs compared with the non-study CHCs. Factors influencing the finding of no additive impact included: aspects of the EHR tools that reduced their utility, barriers to providing the intended implementation support, and study design elements, e.g., inability to adapt the provided support. Factors influencing overall improvements in statin outcomes likely included a secular trend in awareness of statin prescribing guidelines, selection bias where motivated clinics volunteered for the study, and study participation focusing clinic staff on the targeted outcomes.ConclusionsEfforts to implement care guidelines should: ensure adaptability when providing implementation support and conduct formative evaluations to determine the optimal form of such support for a given clinic; consider how study data collection influences adoption; and consider barriers to clinics' ability to use/accept implementation support as planned. More research is needed on supporting change implementation in under-resourced settings like CHCs.Trial registrationClinicalTrials.gov, NCT02325531. Registered 15 December 2014.

Project description:BackgroundMajor Depressive Disorder (MDD) is a disabling mood disorder, profoundly affecting a large number of adolescent's quality of life. To date, no obvious treatment of choice for MDD in adolescents is available and progress in the treatment of depressed adolescents will have important public health implications. Attachment-Based Family Therapy (ABFT), as the only empirically supported family therapy model designed to treat adolescent depression, aims to repair interpersonal ruptures and rebuild an emotionally protective parent-child relationship.ObjectiveTo study the effectiveness of ABFT compared with treatment as usual (TAU) delivered within child- and adolescent mental health services (CAMHS) to adolescents with MDD.MethodSixty adolescents (86.7% girls), aged 13-18 years (M = 14.9, SD = 1.35), with MDD referred to two CAMHS were randomized to 16 weeks of ABFT or TAU. ABFT consisted of weekly therapy sessions (family/individual or both) according to the treatment manual. TAU was not monitored. Primary outcomes were assessed by blinded evaluators at baseline and post-treatment with the Hamilton Depression Scale (HAMD). Self-reported (Beck Depression Inventory-II, BDI-II) depressive symptoms were assessed at baseline, and after 4, 6, 8, 10,12, 14, and 16 weeks. Analyses were performed according to intent-to-treat principles.ResultsAt post-treatment, clinician-rated remission rates on the HAMD (5% in ABFT and 3.33% in TAU, p = 1, OR = 1.54, Fisher's exact test) and self-reported symptoms of depression on the BDI-II did not differ significantly between groups (X2[2, N = 60] = 0.06, p = 0.97). In both treatment groups participants reported significantly reduced depressive symptoms, but the majority (63.3%) of adolescents were still in the clinical range after 16 weeks of treatment.ConclusionABFT was not superior to TAU. Remission and response rates were low in both groups, suggesting none of the treatments were effective in treating MDD in adolescents. Findings must be viewed in the context of the study's small sample size, missing data, and implementation challenges. Continued efforts to improve treatment for MDD in outpatient clinics are warranted. Future research should examine moderators of and mechanisms for individual differences to treatment response, as well as the feasibility and cost-effectiveness of implementing treatment models which may require extensive training and expertise to yield clinically meaningful improvements in non-research settings. Trial registration Clinicaltrials.gov identifier: NCT01830088 https://clinicaltrials.gov/ct2/show/NCT01830088?term=Villab%C3%B8&draw=2&rank=1 Date of registration: April 12, 2013.

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Can we demonstrate that breast cancer "integrative oncology" is effective? A methodology to evaluate the effectiveness of integrative oncology offered in community clinics.

Publications

Can we demonstrate that breast cancer "integrative oncology" is effective? A methodology to evaluate the effectiveness of integrative oncology offered in community clinics.

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