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Randomized Controlled Trial
. 2020 May;28(5):2163-2174.
doi: 10.1007/s00520-019-05028-0. Epub 2019 Aug 14.

CaringGuidance™ after breast cancer diagnosis eHealth psychoeducational intervention to reduce early post-diagnosis distress

Robin M Lally  1   2 , Kevin A Kupzyk  3 , Gina Bellavia  4 , Jennifer Hydeman  5 , Steven Gallo  6 , Vicki S Helgeson  7 , Deborah Erwin  8 , Adam C Mills  9 , Jean K Brown  10
Affiliations
Randomized Controlled Trial

CaringGuidance™ after breast cancer diagnosis eHealth psychoeducational intervention to reduce early post-diagnosis distress

Robin M Lally et al. Support Care Cancer. 2020 May.

Abstract

Purpose: Significant cancer-related distress affects 30-60% of women diagnosed with breast cancer. Fewer than 30% of distressed patients receive psychosocial care. Unaddressed distress is associated with poor treatment adherence, reduced quality of life, and increased healthcare costs. This study aimed to evaluate the preliminary efficacy of a new web-based, psychoeducational distress self-management program, CaringGuidance™ After Breast Cancer Diagnosis, on newly diagnosed women's reported distress.

Methods: One-hundred women, in five states, diagnosed with breast cancer within the prior 3 months, were randomized to 12 weeks of independent use of CaringGuidance™ plus usual care or usual care alone. The primary multidimensional outcome, distress, was measured with the Distress Thermometer (DT), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Impact of Events Scale (IES) at baseline and months 1, 2, and 3. Intervention usage was continually monitored by the data analytic system imbedded within CaringGuidance™.

Results: Although multilevel models showed no significant overall effects, post hoc analysis showed significant group differences in slopes occurring between study months 2 and 3 on distress (F(1,70) = 4.91, p = .03, η2 = .065) measured by the DT, and depressive symptoms (F(1, 76) = 4.25, p = .043, η2 = .053) favoring the intervention.

Conclusions: Results provide preliminary support for the potential efficacy of CaringGuidance™ plus usual care over usual care alone on distress in women newly diagnosed with breast cancer. This analysis supports and informs future study of this self-management program aimed at filling gaps in clinical distress management.

Keywords: Breast cancer; Depressive symptoms; Distress; Internet; Psychoeducation; Self-management.

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Conflict of interest statement

Authors declare that they have no conflict of interest or relationship with the sponsor of this work. Drs. Lally and Bellavia received funding and Dr. Hydeman a consultation fee from the American Cancer Society grant funding this work during its conduct.

Dr. Lally controls the primary data on which this manuscript is based and with permission from the applicable Institutional Review Boards, University at Buffalo SUNY and the University of Nebraska Medical Center would permit reasonable review of the minimal data necessary.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram. A superscript letter “a” denotes that subjects did not complete month 1, month 2, and/or month 3 study measures, and did not withdraw/discontinue. A superscript letter “b” denotes that all subjects allocated to a study condition were included in the analysis
Fig. 2
Fig. 2
Depressive symptoms and distress for intervention and control groups over 3 months. CES-D Center for Epidemiologic Studies Depression Scale
Fig. 3
Fig. 3
Active coping and personal causal attribution (i.e., responsibility) for diagnosis as moderators of CaringGuidance™ effect on depressive symptoms. CES-D Center for Epidemiologic Studies Depression Scale
Fig. 4
Fig. 4
Stressful event in prior year and baseline distress (Distress Thermometer) as moderators of CaringGuidance™ effect on intrusive/avoidant thinking and distress
See this image and copyright information in PMC

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