NCT02679638

Brief Summary

A Multi-center Cross-sectional quantitative study with a preliminary qualitative study part aiming to identify and analyze demand factors, supply factors and perceptions affecting Breast Cancer patients' treatment choices of Breast Cancer patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice. 25 patients and caregivers will participate in the qualitative part and 425 Israeli Breast Cancer patients will participate in the quantitative study.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 4, 2016

Last Update Submit

February 9, 2016

Conditions

Keywords

breast cancertreatment choicefactorperception

Outcome Measures

Primary Outcomes (5)

  • Proportion of active, collaborative and passive patients according to the Control Preferences Scale

    According to the Control Preferences Scale, a questionnaire developed by Degner and Colleagues (Degner, 1997), patients can take fully active role in the treatment decision process or be mostly active, collaborative, mostly passive or fully passive. The study will look at the factors and perceptions affecting patient's decision role.

    Through study completion, an average of 18 months.

  • Large or small hospital choice

    The study interviews patients treated at two large Hospitals (Rambam, Sheba), and two small hospitals (Kaplan, Barzilay) looking for the factors and perceptions affecting large or small hospital choice.

    Through study completion, an average of 18 months.

  • Proportion of patients who chose an oncological regimen more intense than recommended by clinical guidelines.

    The study will look at the factors and perceptions affecting patient's choice to undergo an oncological treatment more intense than recommended by clinical guidelines.

    Through study completion, an average of 18 months.

  • Proportion of patients choosing radical mastectomy over lumpectomy

    The study will look at the factors and perceptions affecting patient's choice to undergo a surgical cancer removal procedure more radical than recommended by clinical guidelines.

    Through study completion, an average of 18 months.

  • Specific surgeon choice

    The study will look at the factors and perceptions affecting patient's choice a specific surgeon in the Israeli healthcare system.

    Through study completion, an average of 18 months.

Study Arms (4)

Kaplan Hospital

Breast cancer survivors recruited at the Kaplan Medical Center

Other: Factors and perceptions questionnaireOther: Qualitative interview

Rambam Hospital

Breast cancer survivors recruited at the Rambam Medical Center

Other: Factors and perceptions questionnaireOther: Qualitative interview

Sheba

Breast cancer survivors recruited at the Sheba Medical Center

Other: Factors and perceptions questionnaire

Barzilai

Breast cancer survivors recruited at the Barzilai Medical Center

Other: Factors and perceptions questionnaire

Interventions

A detailed questionnaire inquiring about demand factors, supply factors and perceptions affecting patients' treatment choices in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice.

BarzilaiKaplan HospitalRambam HospitalSheba

Depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members.

Kaplan HospitalRambam Hospital

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hebrew speaking Jewish women aged 30 - 75 years, diagnosed with breast cancer up to 5 years prior to study recruitment, which have successfully completed all chemotherapy and radiotherapy treatments and are considered disease free.

You may qualify if:

  • Hebrew speaking Jewish women
  • Aged 30 - 75 years
  • Diagnosed with breast cancer up to 5 years prior to study recruitment
  • Successfully completed all chemotherapy and radiotherapy treatments
  • Considered Cancer free

You may not qualify if:

  • Any type of residual cancer
  • Any type of chemotherapy or radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • Adams EK, Houchens R, Wright GE, Robbins J. Predicting hospital choice for rural Medicare beneficiaries: the role of severity of illness. Health Serv Res. 1991 Dec;26(5):583-612.

  • Beaver K, Luker KA, Owens RG, Leinster SJ, Degner LF, Sloan JA. Treatment decision making in women newly diagnosed with breast cancer. Cancer Nurs. 1996 Feb;19(1):8-19. doi: 10.1097/00002820-199602000-00002.

  • Benbassat J, Pilpel D, Tidhar M. Patients' preferences for participation in clinical decision making: a review of published surveys. Behav Med. 1998 Summer;24(2):81-8. doi: 10.1080/08964289809596384.

  • Bouche G, Migeot V, Mathoulin-Pelissier S, Salamon R, Ingrand P. Breast cancer surgery: do all patients want to go to high-volume hospitals? Surgery. 2008 Jun;143(6):699-705. doi: 10.1016/j.surg.2008.03.013. Epub 2008 May 9.

  • Celaya MO, Rees JR, Gibson JJ, Riddle BL, Greenberg ER. Travel distance and season of diagnosis affect treatment choices for women with early-stage breast cancer in a predominantly rural population (United States). Cancer Causes Control. 2006 Aug;17(6):851-6. doi: 10.1007/s10552-006-0025-7.

  • Duric V, Stockler M. Patients' preferences for adjuvant chemotherapy in early breast cancer: a review of what makes it worthwhile. Lancet Oncol. 2001 Nov;2(11):691-7. doi: 10.1016/S1470-2045(01)00559-9.

  • Harris KM. How do patients choose physicians? Evidence from a national survey of enrollees in employment-related health plans. Health Serv Res. 2003 Apr;38(2):711-32. doi: 10.1111/1475-6773.00141.

  • Hawley ST, Griggs JJ, Hamilton AS, Graff JJ, Janz NK, Morrow M, Jagsi R, Salem B, Katz SJ. Decision involvement and receipt of mastectomy among racially and ethnically diverse breast cancer patients. J Natl Cancer Inst. 2009 Oct 7;101(19):1337-47. doi: 10.1093/jnci/djp271. Epub 2009 Aug 31.

  • Jansen SJ, Otten W, Stiggelbout AM. Review of determinants of patients' preferences for adjuvant therapy in cancer. J Clin Oncol. 2004 Aug 1;22(15):3181-90. doi: 10.1200/JCO.2004.06.109.

  • Katz SJ, Lantz PM, Janz NK, Fagerlin A, Schwartz K, Liu L, Deapen D, Salem B, Lakhani I, Morrow M. Patient involvement in surgery treatment decisions for breast cancer. J Clin Oncol. 2005 Aug 20;23(24):5526-33. doi: 10.1200/JCO.2005.06.217.

  • Keating NL, Guadagnoli E, Landrum MB, Borbas C, Weeks JC. Treatment decision making in early-stage breast cancer: should surgeons match patients' desired level of involvement? J Clin Oncol. 2002 Mar 15;20(6):1473-9. doi: 10.1200/JCO.2002.20.6.1473.

  • Nelson JA, Tchou J, Domchek S, Sonnad SS, Serletti JM, Wu LC. Breast reconstruction in bilateral prophylactic mastectomy patients: factors that influence decision making. J Plast Reconstr Aesthet Surg. 2012 Nov;65(11):1481-9. doi: 10.1016/j.bjps.2012.05.001. Epub 2012 May 27.

  • Rees CE, Bath PA. The information needs and source preferences of women with breast cancer and their family members: a review of the literature published between 1988 and 1998. J Adv Nurs. 2000 Apr;31(4):833-41. doi: 10.1046/j.1365-2648.2000.01341.x.

  • Simes RJ, Coates AS. Patient preferences for adjuvant chemotherapy of early breast cancer: how much benefit is needed? J Natl Cancer Inst Monogr. 2001;(30):146-52. doi: 10.1093/oxfordjournals.jncimonographs.a003453.

  • Tropman SE, Ricketts TC, Paskett E, Hatzell TA, Cooper MR, Aldrich T. Rural breast cancer treatment: evidence from the Reaching Communities for Cancer Care (REACH) project. Breast Cancer Res Treat. 1999 Jul;56(1):59-66. doi: 10.1023/a:1006279117650.

  • Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shuli Brammli-Greenberg, PhD

    Head of the Master of Public Health Program at Haifa University

    STUDY CHAIR

Central Study Contacts

Shuli Brammli-Greenberg, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 10, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

February 10, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share