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The Jacki Jacket after mastectomy with reconstruction: a randomized pilot study

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Abstract

Background

Breast cancer patients undergoing mastectomy with reconstruction (TM + R) often experience post-operative discomfort from surgical drains. Despite a variety of garment options for use in the post-operative period, high-quality data assessing the impact of specific garments on post-operative pain are lacking. We report the results of a prospective randomized trial assessing the impact of the Jacki Jacket (JJ), a long-sleeve jacket with inner drain receptacle pockets, on post-discharge pain and quality of life (QOL) after TM + R.

Methods

Breast cancer patients undergoing TM + R at a single institution were randomized post-operatively to receive a JJ or usual care (UC). Participant-reported demographics, pain intensity, and QOL were collected on post-operative day 1 (T1). Following discharge, participants completed a daily pain and medication dairy (T2); on day of drain(s) removal (T3), participants again completed pain and QOL questionnaires. Linear models were used to evaluate associations between JJ use, post-operative pain, and QOL.

Results

From 3/8/17 to 12/20/17, 139 women were randomized. All participants completed T1 measures, 102 returned the T2 diary, and 118 (84.9%) completed T3 questionnaires. There was no significant difference in pain scores between JJ and UC arms at any timepoint. Adjusting for surgery type, age, marital status, depression, and obesity, participants randomized to JJ reported significantly better body image scores (estimate = 12.94, p = 0.009). There were no adverse events.

Conclusions

Although JJ garment use did not impact post-operative pain intensity scores, the significant impact of JJ use on body image supports consideration for inclusion of such garments in post-operative care for patients undergoing TM + R.

Clinical Trial Registration Information

Registered with ClinicalTrials.gov, NCT number NCT02976103, November 18, 2016.

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Acknowledgements

The authors wish to thank Kristin Roper, RN, PhD; Erica Fox, RN, MEd; Margaret “Peggy” Tomasini, RN; and Jacqueline Dejean, BSN, RN, for their many contributions and to Karen Schulte, ARNP, for her initial contact that inspired this trial.

Funding

This study was funded by the Daisy Foundation (No Grant Number) and A Little Easier Recovery (No Grant Number).

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Correspondence to Donna L. Berry.

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The authors declare that they have no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This protocol was reviewed and approved by the Dana-Farber Cancer Institute (DFCI) IRB, in accordance with the applicable Federal regulations set forth at 45 CFR Part 46, and 21 CFR Parts 50 and 56, if applicable.

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Berry, D.L., Blonquist, T.M., Halpenny, B. et al. The Jacki Jacket after mastectomy with reconstruction: a randomized pilot study. Breast Cancer Res Treat 179, 377–385 (2020). https://doi.org/10.1007/s10549-019-05465-9

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  • DOI: https://doi.org/10.1007/s10549-019-05465-9

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