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Randomized Controlled Trial of Survivorship Care Plans Among Low-Income, Predominantly Latina Breast Cancer Survivors.

ABSTRACT: Purpose The purpose of this study was to examine the effects of a randomized controlled trial (RCT) of treatment summaries and survivorship care plans coupled with a nurse counseling session, primarily on physician implementation of and secondarily on patient adherence to recommended survivorship care, among a low-income population of breast cancer survivors (survivors). Methods We recruited 212 low-income, predominantly Latina (72.6%) survivors with stage 0 to III breast cancer, with an average age of 53 years, from two Los Angeles County public hospitals into an RCT of a survivorship care nurse counseling session coupled with the provision of individualized treatment summaries and survivorship care plans to patients and their health care providers from December 2012 to July 2014. One hundred seven survivors received the experimental intervention, and 105 survivors received usual care. Multiple linear regression analyses were performed to assess intervention effects on physician implementation of and patient adherence to recommended survivorship care. Scales that served as covariables were Knowledge of Survivorship Issues, Perceived Efficacy in Patient-Physician Interactions, and Satisfaction With Care and Information. Results Survivors in the intervention group reported greater physician implementation of recommended breast cancer survivorship care, for example, treatment of depression or hot flashes, than did those in the control group (adjusted difference, 16 ± 5.3; P = .003). Baseline Satisfaction With Care and Information was positively associated with physician implementation (coefficient, 5.2 ± 2.2; P = .02). Being married/partnered (-11.8 ± 4.0; P = .004) and age (-0.5 ± 0.2; P = .028) were negatively associated with patient adherence. Conclusion To our knowledge, this is the first RCT of survivorship care plans to show benefits in clinical outcomes, in this case, showing increased physician implementation of recommended breast cancer survivorship care in the intervention group, compared with the control group.

SUBMITTER: Maly RC

PROVIDER: S-EPMC5455593 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Randomized Controlled Trial of Survivorship Care Plans Among Low-Income, Predominantly Latina Breast Cancer Survivors.

Maly Rose C RC Liang Li-Jung LJ Liu Yihang Y Griggs Jennifer J JJ Ganz Patricia A PA

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20170418 16

Purpose The purpose of this study was to examine the effects of a randomized controlled trial (RCT) of treatment summaries and survivorship care plans coupled with a nurse counseling session, primarily on physician implementation of and secondarily on patient adherence to recommended survivorship care, among a low-income population of breast cancer survivors (survivors). Methods We recruited 212 low-income, predominantly Latina (72.6%) survivors with stage 0 to III breast cancer, with an average ...[more]

PMID: 28418767

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Project description:BackgroundBreast cancer is the most common form of cancer among American women, accounting for 23% of all cancer survivors nationally. Yet, the availability of adequate resources and tools for supporting breast cancer survivors has not kept up with the rapid advancement in treatment options, resulting in unmet supportive care needs, particularly among low-income and minority populations. This study explores an alternative means of delivering breast cancer survivorship care plans (SCPs), with the aim of improving survivor morbidity, patient knowledge, and self-management of treatment-related symptoms, as well as addressing inconsistencies in follow-up care visits.ObjectiveThe overall goal of this study is to improve the uptake of SCP recommendations via an educational intervention for breast cancer survivors, to improve treatment-related morbidity, patient knowledge, self-management, and adherence to follow-up visits. The specific aims of the study are to (1) evaluate the feasibility of the online SCP, and (2) assess the impact of the online SCP on survivorship outcomes.MethodsWe will enroll 50 breast cancer survivors who have completed initial breast cancer treatment into a 2-armed, randomized, waitlist-controlled pilot trial, and collect data at baseline and 6 months. For the first aim, we will use mixed methods, including surveys and personal interviews among the intervention group, to determine the feasibility of providing an online, interactive SCP (called ACESO) based on the survivors' online user experience and their short-term adoption. For the secondary aim, we will compare the 2 groups to assess the primary outcomes of survivor knowledge, self-efficacy for self-management, perceived peer support, and adherence to SCP-recommended posttreatment follow-up visits to oncology and primary care; and the secondary outcomes of treatment-related morbidity (body weight, fatigue, depression, anxiety, sexual function, distress, and sleep quality). We assess these outcomes by using measurements from validated instruments with robust psychometric properties.ResultsWe have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors. Approval for the study protocol has been obtained from the Institutional Review Board. An advisory board has also been established to provide oversight and recommendations on the conduct of the study. The study will be completed over a period of 2 years.ConclusionsThe results of this pilot study will inform the feasibility and design of a larger-scale pragmatic trial to evaluate the impact of an online breast cancer SCP on treatment-related morbidity and self-efficacy for self-management.International registered report identifier (irrid)PRR1-10.2196/23414.

Project description:PURPOSE:Breast cancer survivorship care plans (SCP) have limited content addressing women's health issues. This trial tested if young breast cancer survivors who receive a web-based, women's health SCP were more likely to improve on at least one of the four targeted issues (hot flashes, fertility-related concerns, contraception, and vaginal symptoms) compared to attention controls. METHODS:A randomized controlled trial recruited female survivors ages 18-45 at diagnosis, 18-50 at enrollment, completed primary cancer treatment, and had a significant women's health issue: moderate or higher fertility-related concerns;???4 hot flashes/day with ??1 of moderate severity; ??1 moderate vaginal atrophy symptoms; or not contracepting/using less effective methods. Survivors underwent stratified, block randomization with equal allocation to intervention and control groups. The intervention group accessed the online SCP; controls accessed curated resource lists. In intention-to-treat analysis, the primary outcome of improvement in at least one issue by 24 weeks was compared by group. RESULTS:182 participants (86 intervention, 96 control), mean age 40.0?±?5.9 and 4.4?±?3.2 years since diagnosis, were randomized. 61 intervention group participants (70.9%) improved, compared to 55 controls (57.3%) (OR 1.82, 95% CI 0.99-3.4, p?=?0.057). The following issue-specific improvements were observed in the intervention versus control arms: fertility-related concerns (27.9% vs. 14.6%, OR 2.3, 95% CI 1.1-4.8); hot flashes (58.5% vs. 55.8%, OR 1.1, 95% CI 0.57-2.2); vaginal symptoms (42.5% vs. 40.7%, OR 1.1, 95% CI 0.6-2.0); contraception (50% vs. 42.6%, OR 1.4, 95% CI 0.74-2.5). CONCLUSIONS:In young breast cancer survivors, a novel, web-based SCP did not result in more change in the primary outcome of improvement in at least one of the four targeted women's health issues, than the attention control condition. The intervention was associated with improved infertility concerns, supporting efficacy of disseminating accessible, evidence-based women's health information to this population.

Dataset Information

Randomized Controlled Trial of Survivorship Care Plans Among Low-Income, Predominantly Latina Breast Cancer Survivors.

Publications

Randomized Controlled Trial of Survivorship Care Plans Among Low-Income, Predominantly Latina Breast Cancer Survivors.

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