BC-PROM: Validation of a Patient-reported Outcomes Measure for Patients with Breast Cancer

Overview

Journal Medicine (Baltimore)

Specialty General Medicine

Date 2017 Apr 27

PMID 28445314

Citations 5

Authors

Xiaojuan Hu

Chunsen Zhang

Yanbo Zhang

Affiliations

Soon will be listed here.

Abstract

Key issues of treatment for patients with breast cancer such as patient satisfaction with treatments, compliance, and some side effects are essential for evaluating quality of life by patient-reported outcomes in clinical trials. The study aimed to develop and evaluate a specific patient-reported measure which included physical, psychological, social, and therapeutic domain for assessing the survival of patients with breast cancer.The pool of items was drafted after a theoretical revision and cognitive interviews with women with breast cancer. The draft scale was formed after the adjustment of the items and dimensions, and the selected items were submitted to expert's judgments. Five statistical methods were used to select these items by 2 validation samples. The final scale was administered to a sample of 417 patients from 8 hospitals and 135 controls for reliability, validity, and responsive analyses.The final BC-PROM consisted of 52 items, 13 subdomains, and 4 domains, being developed after preexamination and formal examination. Cronbach alpha coefficient was 0.902 and 0.712 for the full scale and therapeutic domain. The structural validity results showed that the multidimensional measurement of the scale fulfilled expectations. Differences in the BC-PROM mean scores were significant between cancer patients and healthy participants in 13 subdomains (P < .05), indicating good responsiveness. Among the sample survey of patients, the scale copy acceptance rate was 98.2%, completion rate 94.6%, and average filling time 10 minutes.The new and reliable BC-PROM was developed in patients with breast cancer and applied to clinical treatment evaluation and clinical trials for such patients.

Citing Articles

Psychometric Properties and Factorial Analysis of the Arabic McGill-QoL Questionnaire in Breast Cancer.

Omar M, Alnahdi A Breast Cancer (Dove Med Press). 2023; 15:813-824.

PMID: 38020050 PMC: 10656849. DOI: 10.2147/BCTT.S422369.

The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol.

Xavier Neves da Silva L, Leite J, Conrado Ignacio A, Massierer F, Pfeifer L, Dos Santos Cardoso L Pilot Feasibility Stud. 2023; 9(1):165.

PMID: 37752564 PMC: 10521479. DOI: 10.1186/s40814-023-01393-0.

Patients' experiences of engaging with electronic Patient Reported Outcome Measures (PROMs) after the completion of radiation therapy for breast cancer: a pilot service evaluation.

Hughes J, Flood T J Med Radiat Sci. 2023; 70(4):424-435.

PMID: 37550951 PMC: 10715367. DOI: 10.1002/jmrs.711.

Patient-Reported Outcome Measures of Breast Cancer Surgery: Evidence Review and Tool Adaptation.

Marzban S, Shokravi S, Abaei S, Fattahi P, Karami M, Tajari F Cureus. 2022; 14(8):e27800.

PMID: 36134055 PMC: 9481225. DOI: 10.7759/cureus.27800.

Identifying breast cancer recurrence histories via patient-reported outcomes.

Beatty J, Sun Q, Markowitz D, Chubak J, Huang B, Etzioni R J Cancer Surviv. 2021; 16(2):388-396.

PMID: 33852139 PMC: 8525779. DOI: 10.1007/s11764-021-01033-7.

References

Lee C, Sunu C, Pignone M . Patient-reported outcomes of breast reconstruction after mastectomy: a systematic review. J Am Coll Surg. 2009; 209(1):123-33. PMC: 2721826. DOI: 10.1016/j.jamcollsurg.2009.02.061. View

Montazeri A . Health-related quality of life in breast cancer patients: a bibliographic review of the literature from 1974 to 2007. J Exp Clin Cancer Res. 2008; 27:32. PMC: 2543010. DOI: 10.1186/1756-9966-27-32. View

Chopra I, Kamal K . A systematic review of quality of life instruments in long-term breast cancer survivors. Health Qual Life Outcomes. 2012; 10:14. PMC: 3280928. DOI: 10.1186/1477-7525-10-14. View

Cleeland C, Sloan J . Assessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): searching for standards. J Pain Symptom Manage. 2010; 39(6):1077-85. DOI: 10.1016/j.jpainsymman.2009.05.025. View

Emons W, Meijer R, Denollet J . Negative affectivity and social inhibition in cardiovascular disease: evaluating type-D personality and its assessment using item response theory. J Psychosom Res. 2007; 63(1):27-39. DOI: 10.1016/j.jpsychores.2007.03.010. View

Hays R, Morales L, Reise S . Item response theory and health outcomes measurement in the 21st century. Med Care. 2000; 38(9 Suppl):II28-42. PMC: 1815384. DOI: 10.1097/00005650-200009002-00007. View

Hagman B, Kuerbis A, Morgenstern J, Bux D, Parsons J, Heidinger B . An Item Response Theory (IRT) analysis of the Short Inventory of Problems-Alcohol and Drugs (SIP-AD) among non-treatment seeking men-who-have-sex-with-men: evidence for a shortened 10-item SIP-AD. Addict Behav. 2009; 34(11):948-54. PMC: 2726268. DOI: 10.1016/j.addbeh.2009.06.004. View

Spagnola S, Zabora J, BrintzenhofeSzoc K, Hooker C, Cohen G, Baker F . The Satisfaction with Life Domains Scale for Breast Cancer (SLDS-BC). Breast J. 2003; 9(6):463-71. DOI: 10.1046/j.1524-4741.2003.09603.x. View

Broekman B, Niti M, Nyunt M, Ko S, Kumar R, Ng T . Validation of a brief seven-item response bias-free geriatric depression scale. Am J Geriatr Psychiatry. 2011; 19(6):589-96. DOI: 10.1097/JGP.0b013e3181f61ec9. View

10.

Baxter N, Goodwin P, McLeod R, Dion R, Devins G, Bombardier C . Reliability and validity of the body image after breast cancer questionnaire. Breast J. 2006; 12(3):221-32. DOI: 10.1111/j.1075-122X.2006.00246.x. View

11.

Eskelinen M, Ollonen P . Psychosocial risk scale (PRS) for breast cancer in patients with breast disease: a prospective case-control study in Kuopio, Finland. Anticancer Res. 2009; 29(11):4765-70. View

12.

Neal D, Corbin W, Fromme K . Measurement of alcohol-related consequences among high school and college students: application of item response models to the Rutgers Alcohol Problem Index. Psychol Assess. 2006; 18(4):402-14. DOI: 10.1037/1040-3590.18.4.402. View

13.

Kanatas A, Velikova G, Roe B, Horgan K, Ghazali N, Shaw R . Patient-reported outcomes in breast oncology: a review of validated outcome instruments. Tumori. 2013; 98(6):678-88. DOI: 10.1177/030089161209800602. View

14.

Luckett T, King M . Choosing patient-reported outcome measures for cancer clinical research--practical principles and an algorithm to assist non-specialist researchers. Eur J Cancer. 2010; 46(18):3149-57. DOI: 10.1016/j.ejca.2010.08.002. View

15.

Kahler C, Strong D, Hayaki J, Ramsey S, Brown R . An item response analysis of the Alcohol Dependence Scale in treatment-seeking alcoholics. J Stud Alcohol. 2003; 64(1):127-36. DOI: 10.15288/jsa.2003.64.127. View

16.

Thomas M, Brown G, Thompson W, Voyvodic J, Greve D, Turner J . An application of item response theory to fMRI data: prospects and pitfalls. Psychiatry Res. 2013; 212(3):167-74. PMC: 3775707. DOI: 10.1016/j.pscychresns.2013.01.009. View

17.

Brady M, Cella D, Mo F, Bonomi A, Tulsky D, Lloyd S . Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997; 15(3):974-86. DOI: 10.1200/JCO.1997.15.3.974. View

18.

Thompson H, Valdimarsdottir H, Winkel G, Jandorf L, Redd W . The Group-Based Medical Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 2004; 38(2):209-18. DOI: 10.1016/j.ypmed.2003.09.041. View

19.

Harrington S, Michener L, Kendig T, Miale S, George S . Patient-reported upper extremity outcome measures used in breast cancer survivors: a systematic review. Arch Phys Med Rehabil. 2013; 95(1):153-62. PMC: 4162515. DOI: 10.1016/j.apmr.2013.07.022. View

20.

Patoo M, Allahyari A, Moradi A, Payandeh M . Persian Version of Functional Assessment of Cancer Therapy- Breast (FACT-B) Scale: Confirmatory Factor Analysis and Psychometric Properties. Asian Pac J Cancer Prev. 2015; 16(9):3799-803. DOI: 10.7314/apjcp.2015.16.9.3799. View