Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients

February 9, 2016 updated by: University of Haifa

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shuli Brammli-Greenberg, PhD
  • Phone Number: +972508159054
  • Email: Shuli@jdc.org.il

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kaplan Hospital
Breast cancer survivors recruited at the Kaplan Medical Center
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.
Other: Qualitative interview
Depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members.
Rambam Hospital
Breast cancer survivors recruited at the Rambam Medical Center
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.
Other: Qualitative interview
Depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members.
Sheba
Breast cancer survivors recruited at the Sheba Medical Center
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.
Barzilai
Breast cancer survivors recruited at the Barzilai Medical Center
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of active, collaborative and passive patients according to the Control Preferences Scale
Time Frame: Through study completion, an average of 18 months.
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
Time Frame: Through study completion, an average of 18 months.
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.
Time Frame: Through study completion, an average of 18 months.
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
Time Frame: Through study completion, an average of 18 months.
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
Time Frame: Through study completion, an average of 18 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Investigators

  • Study Chair: Shuli Brammli-Greenberg, PhD, Head of the Master of Public Health Program at Haifa University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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