Breast CancerNCT02679638
Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients
An observational study of Breast Cancer, run by University of Haifa.
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… Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Factors and perceptions questionnaire and Qualitative interview
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Any type of residual cancer
- Any type of chemotherapy or radiotherapy
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Factors and perceptions questionnaire, Qualitative interview
- Keywords
- breast cancer, treatment choice, factor, perception
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factors and perceptions questionnaireOther
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 interviewOther
Depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members.
| Study group | Role | What they receive |
|---|---|---|
| Kaplan Hospital | Breast cancer survivors recruited at the Kaplan Medical Center Receives: Other: Factors and perceptions questionnaire; Other: Qualitative interview | |
| Rambam Hospital | Breast cancer survivors recruited at the Rambam Medical Center Receives: Other: Factors and perceptions questionnaire; Other: Qualitative interview | |
| Sheba | Breast cancer survivors recruited at the Sheba Medical Center Receives: Other: Factors and perceptions questionnaire | |
| Barzilai | Breast cancer survivors recruited at the Barzilai Medical Center Receives: Other: Factors and perceptions questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuli Brammli-Greenberg, PhD, Study chair, Head of the Master of Public Health Program at Haifa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679638
- Sponsor's protocol ID
- 27-15
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 1743970Beaver 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.
PubMed 8904382Benbassat 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.
PubMed 9695899Bouche 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.
PubMed 18549885Celaya 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.
PubMed 16783613Duric 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.
PubMed 11902540Harris 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.
PubMed 12785569Hawley 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.
PubMed 19720966Jansen 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.
PubMed 15284271Katz 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.
PubMed 16110013Keating 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.
PubMed 11896094Nelson 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.
PubMed 22640643Rees 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.
PubMed 10759979Simes 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.
PubMed 11773309Tropman 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.
PubMed 10517343
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02679638
- Acronym / sponsor ID
- 27-15
- Conditions
- Breast Cancer
- Keywords
- breast cancer, treatment choice, factor, perception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kaplan Hospital | – | Other: Factors and perceptions questionnaire, Other: Qualitative interviewBreast cancer survivors recruited at the Kaplan Medical Center |
| Rambam Hospital | – | Other: Factors and perceptions questionnaire, Other: Qualitative interviewBreast cancer survivors recruited at the Rambam Medical Center |
| Sheba | – | Other: Factors and perceptions questionnaireBreast cancer survivors recruited at the Sheba Medical Center |
| Barzilai | – | Other: Factors and perceptions questionnaireBreast cancer survivors recruited at the Barzilai Medical Center |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Any type of residual cancer
- Any type of chemotherapy or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Factors and perceptions questionnaireA 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 | Barzilai, Kaplan Hospital, Rambam Hospital, Sheba |
| Qualitative interviewDepth interviews with 20 breast cancer patients, 2 spouses and 3 staff members. | Other | Kaplan Hospital, Rambam Hospital |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Results publication: PubMed 1743970Adams 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.
- Results publication: PubMed 8904382Beaver 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.
- Results publication: PubMed 9695899Benbassat 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.
- Results publication: PubMed 18549885Bouche 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.
- Results publication: PubMed 16783613Celaya 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.
- Results publication: PubMed 11902540Duric 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.
- Results publication: PubMed 12785569Harris 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.
- Results publication: PubMed 19720966Hawley 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.
- Results publication: PubMed 15284271Jansen 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.
- Results publication: PubMed 16110013Katz 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.
- Results publication: PubMed 11896094Keating 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.
- Results publication: PubMed 22640643Nelson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuli Brammli-Greenberg, PhD study chair
Head of the Master of Public Health Program at Haifa University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Haifa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuli Brammli-Greenberg, PhD (+972508159054, Shuli@jdc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of active, collaborative and passive patients according to the Control Preferences Scale (time frame: Through study completion, an average of 18 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679638, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.