Yukari Isaka1, Ai Hori2, Rie Tanaka2, Masao Ichikawa2. 1. Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan. s1530359@u.tsukuba.ac.jp. 2. Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.
Abstract
BACKGROUND: The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial. METHODS: The participants were women aged 20-69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups. RESULTS: After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87-3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination. CONCLUSIONS: Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.
RCT Entities:
BACKGROUND: The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial. METHODS: The participants were women aged 20-69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups. RESULTS: After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87-3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination. CONCLUSIONS: Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.
Entities:
Keywords:
Cervical cancer; Cervical cancer screening; False-positive results; Psychological distress; Randomized control trial; Screening notification
Authors: N M Gray; L Sharp; S C Cotton; L F Masson; J Little; L G Walker; M Avis; Z Philips; I Russell; D Whynes; M Cruickshank; C M Woolley Journal: Br J Cancer Date: 2006-05-08 Impact factor: 7.640