Advanced Breast CancerNCT01876238
Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals in Breast Cancer
A study testing T-PAT and Surveys in people with Advanced Breast Cancer and Stage 4 Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This research study will examine how patients with advanced breast cancer and their oncology team communicate and plan ongoing care.The purpose of this study is to find out more about care planning during advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer, Stage 4 Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- T-PAT and Surveys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2015
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women newly or currently diagnosed with stage 4 or recurrent breast cancer
- Patients of Dr. Paula Silverman at Seidman Cancer Center
- Ambulatory
- Able to understand and participate in a discussion about their disease progression
Who cannot join
- Hospitalized
- Unable to speak English
- Unable to attend an office visit
- ECOG performance score of >3
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals With Patients Diagnosed With Advanced Breast Cancer
This research study will examine how patients with advanced breast cancer and their oncology team communicate and plan ongoing care.The purpose of this study is to find out more about care planning during advanced breast cancer. The study will see if certain aspects of communication make a difference in how patients understand their illness.
Read the detailed description
The new communication practice (T-PAT) is a team approach for discussing prognosis and treatment goals. T-PAT is specifically designed to a) increase understanding of the prognosis and treatment goal, b) decrease illness uncertainty, and c) help the patient preserve hope for the future.This dedicated clinical visit features a structured discussion of prognosis, treatment goals and options, and end of life concerns. The planned team discussion will include information contributions for the treating medical oncologist, an oncology nurse and social worker who currently work together to provide breast cancer care.
Primary Objectives:
- Assess the feasibility of implementing the T-PAT prognosis discussion intervention.
- Compare the effects of T-PAT vs. usual care on pertinent patient reported outcomes including: a) understanding of the prognosis and treatment goal, b) illness uncertainty, and c) hope.
- First, a survey will be administered to patients in the waiting room before the next office visit. This should take 15-20 minutes.
- The second part involves participating in a scheduled appointment that will be audio-recorded and focus on sharing information about the patient's illness. Patients will be randomized to either participate in an appointment featuring new communication practices (T-PAT)or a regular care appointment.
- The third part involves a 20 minute survey, after the appointment, with a member of the study staff. This will take place over the telephone one or two days after the appointment.
- The fourth part is completion of a written reflection on the patients participation in the study, which will be returned in a pre-addressed, stamped envelope. Generally, this should take about 15 minutes.
- Being tested
- T-PAT, Surveys
- Keywords
- Breast Cancer, Patient-Doctor Communication, Supportive Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-PATOther
SurveysOther
Also called State Hope Scale, Tolerate Adverse States Survey, Physical Functioning Measure (MOS-PF), Beleif in CUrability (BIC)
Pre-test and posttest surveys and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| T-PAT Intervention | Experimental | Prognosis discussion intervention with study team. Receives: Other: T-PAT; Other: Surveys |
| Control: Standard Care | Active comparator | Usual care appointment Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention
Accuracy and completion rate of the planned intervention components will be observed.
Measured: 8 months
Secondary outcomes (6)
Patient Recorded Measures: Hope
Using the Snyder et al.'s State Hope Scale
Measured: 8 months
Patient Recorded Measures: Willingness to Tolerate Adverse States
Six-Item scale that measures motivation to endure burden associated with aggressive care. Higher scores indicate a greater willingness to tolerate adverse states.
Measured: 8 months
Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)
Assess patient physical function
Measured: 8 months
Patient Recorded Measures: Belief in Curability (BIC)
Assess patients perceptions about prognosis independent of what they recall being told by their doctor.
Measured: 8 months
Patient Recorded Measures: Illness Uncertainty
16-item scale tapping patient uncertainty about symptoms, diagnosis, treatment, and future plans.
Measured: 8 months
Patient Recorded Measures: Treatment Goal Preference
Patients will be asked to report their preference for aggressive care.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Step, PhD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876238
- Sponsor's protocol ID
- CASE12112
- Status last verified
- Nov 2015
- First submitted
- 10 Jun 2013
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals With Patients Diagnosed With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01876238
- Acronym / sponsor ID
- CASE12112
- Keywords
- Breast Cancer, Patient-Doctor Communication, Supportive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jun 2013 (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.
This research study will examine how patients with advanced breast cancer and their oncology team communicate and plan ongoing care.The purpose of this study is to find out more about care planning during advanced breast cancer. The study will see if certain aspects of communication make a difference in how patients understand their illness.
Detailed description
The new communication practice (T-PAT) is a team approach for discussing prognosis and treatment goals. T-PAT is specifically designed to a) increase understanding of the prognosis and treatment goal, b) decrease illness uncertainty, and c) help the patient preserve hope for the future.This dedicated clinical visit features a structured discussion of prognosis, treatment goals and options, and end of life concerns. The planned team discussion will include information contributions for the treating medical oncologist, an oncology nurse and social worker who currently work together to provide breast cancer care.
Primary Objectives:
- Assess the feasibility of implementing the T-PAT prognosis discussion intervention.
- Compare the effects of T-PAT vs. usual care on pertinent patient reported outcomes including: a) understanding of the prognosis and treatment goal, b) illness uncertainty, and c) hope.
- First, a survey will be administered to patients in the waiting room before the next office visit. This should take 15-20 minutes.
- The second part involves participating in a scheduled appointment that will be audio-recorded and focus on sharing information about the patient's illness. Patients will be randomized to either participate in an appointment featuring new communication practices (T-PAT)or a regular care appointment.
- The third part involves a 20 minute survey, after the appointment, with a member of the study staff. This will take place over the telephone one or two days after the appointment.
- The fourth part is completion of a written reflection on the patients participation in the study, which will be returned in a pre-addressed, stamped envelope. Generally, this should take about 15 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-PAT Intervention | Experimental | Other: T-PAT, Other: SurveysPrognosis discussion intervention with study team. |
| Control: Standard Care | Active comparator | Other: SurveysUsual care appointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women newly or currently diagnosed with stage 4 or recurrent breast cancer
- Patients of Dr. Paula Silverman at Seidman Cancer Center
- Ambulatory
- Able to understand and participate in a discussion about their disease progression
Key exclusion criteria (4 listed)
- Hospitalized
- Unable to speak English
- Unable to attend an office visit
- ECOG performance score of >3
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 |
|---|---|---|
| T-PAT | Other | T-PAT Intervention |
| SurveysAlso: State Hope Scale, Tolerate Adverse States Survey, Physical Functioning Measure (MOS-PF), Beleif in CUrability (BIC)Pre-test and posttest surveys and questionnaires | Other | Control: Standard Care, T-PAT Intervention |
Primary outcome
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention
Time frame: 8 months
Accuracy and completion rate of the planned intervention components will be observed.
6 secondary outcomes
Patient Recorded Measures: Hope
Time frame: 8 months
Patient Recorded Measures: Willingness to Tolerate Adverse States
Time frame: 8 months
Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)
Time frame: 8 months
Patient Recorded Measures: Belief in Curability (BIC)
Time frame: 8 months
Patient Recorded Measures: Illness Uncertainty
Time frame: 8 months
Patient Recorded Measures: Treatment Goal Preference
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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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.
Mary Step, PhD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-PAT and Surveys in people with Advanced Breast Cancer and Stage 4 Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2015.