Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients. Multi-center Cross-sectional Study in Israel Among Breast Cancer Survivors, With a Preliminary Qualitative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02679638
• Other study ID #: 27-15
• Status: Not yet recruiting
• Phase: N/A
• First received: February 4, 2016
• Last updated: February 9, 2016
• Start date: February 2016
• Est. completion date: May 2017

Study information

• Verified date: February 2016
• Source: University of Haifa
• Contact: Shuli Brammli-Greenberg, PhD
• Phone: +972508159054
• Email: Shuli[@]jdc.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

Background:

Breast Cancer (BC) is the most common cancer in women worldwide. Newly diagnosed BC patients are asked to participate in a number of treatment related decisions. No research has systematically studied the full decision sequence in a disease such as BC, analyzing demand factors, supply factors and patient perceptions.

Study goal:

Identify and analyze demand factors, supply factors and perceptions affecting BC patients' treatment choices, and model the demand function of BC patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice.

Study hypothesis: Patient perceptions will have at least as much impact as demand and supply factors.

Study design:

Two stage study. A preliminary qualitative study, holding depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members is taking place these days. The qualitative study findings will be used to develop a survey questionnaire for a cross sectional quantitative study, interviewing a quota sample of 425 breast cancer survivors, diagnosed up to 5 years prior to joining the study, who have successfully completed all radiation therapy and chemotherapy.

Data analysis:

Qualitative data will be analyzed according to the Criteria Bases Qualitative Methodology. Quantitative data will be analyzed by two-variable statistical analysis and multi-variable statistical analysis adjusted to the nature of the dependent and independent variables.

Possible policy recommendations:

Forming consulting teams for cancer patients. Improving medical information communication. Focusing patients on the key decisions they face. Evaluating patient needs using demand factors, supply factors and perceptions to create systemic tools helping them face treatment decisions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: May 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any type of residual cancer

• Any type of chemotherapy or radiotherapy

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Factors and perceptions questionnaire
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.
• Qualitative interview
Depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

Bouche G, Migeot V, Mathoulin-Pélissier 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. — View Citation

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):85 — View Citation

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

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. Review. — View Citation

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. — View Citation

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 — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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.2012.05.0 — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No