Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT03061175
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 94
• Locations: 3
• Arms: 2
• Actual Duration (Months): 30.6
• Patients Per Site: 31.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This pilot randomized clinical trial studies how well a web-based decision aid works in improving informed decisions in patients with stage 0-IIIA breast cancer considering contralateral prophylactic mastectomy (CPM). A web-based decision aid (DA) may help doctors determine how patients make decisions about whether or not to have contralateral prophylactic mastectomy.

Condition or Disease	Intervention/Treatment	Phase
Stage 0 Breast Cancer; Stage I Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer	Other: Internet-Based Intervention; Other: Survey Administration	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. To develop a feasible web-based decision aid (DA).

SECONDARY OBJECTIVES:

1. To provide preliminary data on the impact of the contralateral prophylactic mastectomy (CPM)-DA on preparedness to make the CPM decision, decisional conflict, CPM knowledge, psychosocial factors, perceived risk for cancer in the healthy/breast/metastatic disease, cancer recurrence/metastasis worry, cancer distress and intention to have CPM.

OUTLINE:

PHASE I (PROTOTYPE DEVELOPMENT AND TESTING): Patients attend an interview and are asked questions about experiences with CPM, reasons they chose and did not choose CPM, and CPM satisfaction for 60 minutes. Patients then receive access to web-based CPM-DA and attend an interview over 90 minutes to provide feedback on module and to complete a prototype evaluation.

PHASE II (CPM-DA FEASIBILITY TRIAL): Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo usual care (UC) available to patients considering CPM and receive information from a medical oncologist about CPM.

ARM II: Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.

After completion of study treatment, patients are followed up at 2-4 weeks and 6 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Facilitating Informed Decisions for Contralateral Prophylactic Mastectomy
• Actual Study Start Date: Sep 24, 2015
• Actual Primary Completion Date: Apr 11, 2018
• Actual Study Completion Date: Apr 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA) Patients receive a website address, a secure username and password, and instructions for using the web-based Contralateral Prophylactic Mastectomy (CPM)- Decision Aid (DA).	Other: Internet-Based Intervention; Receive web-based CPM-DA; Other: Survey Administration; Ancillary studies
Experimental: Arm II (Usual Care) Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.	Other: Survey Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants [2-4 week follow up]

   CPM knowledge is a 10-item multiple-choice measure developed by author Kirsten and Smith. Scores range from 0-100% correct with a higher score equaling more correct knowledge items. Items assessed understanding of the definition of CPM, surgical recovery time and risks/side effects, whether or not CPM improves survival, and whether CPM reduced the risk for disease progression. Will characterize the data using standard methods (estimated marginal means, standard errors, and Cohen's d effect sizes) separately by study arm. At follow-up scores will be reported as the difference between the knowledge score at two time points- the baseline knowledge score and follow-up knowledge score for both the CPM-DA arm and the UC arm.

2. Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys [2-4 week follow up]

   Preparedness for the CPM decision was assessed using a 16-item scale adapted from the Ottawa Preparation for Decision Making scale modified to address the CPM decision. Items evaluated the amount of and satisfaction with information about CPM. Scores were reported as a mean across the items and ranged from 1-4 with 1 = Strongly Disagree; 2= Moderately Disagree; 3 = Moderately Agree; 4= Strongly Agree Higher scores = more prepared. Outcomes reported as estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions.

3. Decisional Conflict Assessed by the Decisional Conflict Scale [2-4 week follow up]

   The Ottawa Decisional Conflict scale has 16 items and five subscales: support for the decision, uncertainty about the decision, level of relevant information, clarity of relevant values, and effective decision. Items are rated on a 5-point Likert scale (0= Strongly Disagree to 4 = Strongly Agree). Scores for the five subscales were calculated by an average that was multiplied by 25, which is recommended by the scale's developers. Thus, scores can range from 0 (no decision conflict) to 100 (high decision conflict). Higher scores indicate more decisional conflict.

Secondary Outcome Measures

1. Self-Efficacy at 2-4 Week Follow up Survey [2-4 week follow up]

   Self-efficacy was a 3-item measure of confidence in the ability to manage worries and uncertainty about a possible recurrence of breast cancer, concerns about future surveillance, and worries about undergoing future surveillance. Results reported as Estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions. Scores were reported as the mean across the 3 items and ranged from 1 = Not at all confident; 2 = Somewhat confident; 3 = Moderately confident; 4 = Very confident; 5 = Extremely confident. Higher scores indicate more self-efficacy.

2. Cancer Worry Assessed by 2-4 Week Follow-up Surveys [2-4 week follow-up]

   Worry is measured by a single item that asks how worried the participant is about having another form of breast cancer on a four-point Likert scale 1= not at all worried and 4 = very worried. Higher scores indicate more worry. Results reported as estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions

3. CPM Motivations Assessed by Surveys [2-4 week follow up]

   Reasons for CPM were measured by an 11-item scale developed after a review of the qualitative and quantitative literature on motivations for CPM and interviews with women who chose or did not choose CPM. Scored were reported as a mean score across the 11 items. The scale was scored on a 1-4 scale from not at all important to Yes, extremely important and Higher score = more reasons/motivations. Outcomes reported as Estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions

4. Perceived Risk of Recurrence Assessed by 2 Items on Surveys [2-4 week follow-up]

   Perceived risk was measured by two items. One item assessed contralateral breast cancer risk risk after unilateral mastectomy and radiation. The second item assessed perceived risk for chest wall recurrence after CPM. The first item asked "Out of 100 women with early breast cancer are treated with a single mastectomy or lumpectomy and radiation, about how many will develop breast cancer in the "other breast" in the 5 years after treatment? ___ women out of 100". The second item assessed risk for chest wall recurrence after bilateral mastectomy using the same scale 2. "If 100 women with early breast cancer have both breasts removed, how many will have breast cancer come back in the chest wall area of the "other breast" in the five years after treatment?". Outcomes reported as Estimated marginal means and standard errors for usual care and B-Sure decision aid conditions of the # out of 100 that women reported.

Other Outcome Measures

1. User Interface Satisfaction Survey [2-4 week follow up]

   The scale has 27 items and four subscales: usefulness, ease of use, ease of learning, and satisfaction. Scales ranged from 1-7 with 1 being not at all or strongly disagree up to 7 being definitely or strongly agree.

2. B-Sure Use- Time [2-4 week follow up]

   Basic descriptive information will be gathered regarding the length of time modules are viewed. B-Sure use will be assessed by average time spent in B-Sure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation)

• PHASE I: Speaks and reads English

• PHASE I: Women with sporadic cancers (WSC) (does not have hereditary breast/ovarian cancer syndrome [BReast CAncer gene (BRCA) carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; the Tyrer-Cuzick model calculates a personal lifetime risk of breast cancer based on multiple factors; it has become the standard model because it incorporates not only factors such as estrogen exposure and first degree relatives, but also second degree relatives and paternal lineage; a lifetime risk of 20% or greater is considered high risk and would necessitate increased screening methods to the traditional annual mammogram; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation

• PHASE I: Able to provide meaningful informed consent

• PHASE II: Completed initial surgical consult with breast cancer surgeon at Cancer Institute of New Jersey (CINJ)/Massachusetts General Hospital (MGH)/Memorial Sloan Kettering Cancer Center (MSKCC) and is considering CPM, regardless of the surgical treatment of their primary breast cancer (lumpectomy/mastectomy)

• PHASE II: Has home internet access

• PHASE II: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer

• PHASE II: Speaks and reads English

• PHASE II: WSC (does not have hereditary breast/ovarian cancer syndrome [BRCA carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation

• PHASE II: Able to provide meaningful informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Charlestown	Massachusetts	United States	02129
2	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
3	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Sharon Manne, Rutgers Cancer Institute of New Jersey

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 22, 2018
• Informed Consent Form - Jan 9, 2018

More Information

Publications

None provided.

• Responsible Party: Sharon Manne, PhD, Professor of Medicine, Rutgers Cancer Institute of New Jersey
• ClinicalTrials.gov Identifier: NCT03061175
• Other Study ID Numbers: Pro20150001914; NCI-2017-00173; Pro20150001914; 131504; P30CA072720; R21CA187643
• First Posted: Feb 23, 2017
• Last Update Posted: Apr 20, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Breast Neoplasms; Breast Carcinoma In Situ

Study Results

Participant Flow

Arm/Group Title	Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based Contralateral Prophylactic Mastectomy (CPM)-Decision Aid (DA). Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering Contralateral Prophylactic Mastectomy (CPM) and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Period Title: Baseline
STARTED	47	47
COMPLETED	46	47
NOT COMPLETED	1	0
Period Title: Baseline
STARTED	45	47
COMPLETED	39	44
NOT COMPLETED	6	3
Period Title: Baseline
STARTED	45	46
COMPLETED	41	39
NOT COMPLETED	4	7

Baseline Characteristics

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)	Total
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies	Total of all reporting groups
Overall Participants	46	47	93
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.5 (8.4)	45.5 (8.4)	46.5 (8.4)
Sex: Female, Male (Count of Participants)
Female	46 100%	47 100%	93 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.2%	0 0%	1 1.1%
Asian	2 4.3%	3 6.4%	5 5.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 4.3%	4 8.5%	6 6.5%
White	39 84.8%	35 74.5%	74 79.6%
More than one race	2 4.3%	1 2.1%	3 3.2%
Unknown or Not Reported	0 0%	4 8.5%	4 4.3%
Education (Count of Participants)
High school	2 4.3%	3 6.4%	5 5.4%
Some college	8 17.4%	6 12.8%	14 15.1%
Tech or trade school	1 2.2%	1 2.1%	2 2.2%
College Graduate	15 32.6%	17 36.2%	32 34.4%
Some Graduate Work	2 4.3%	3 6.4%	5 5.4%
Graduate Degree	18 39.1%	17 36.2%	35 37.6%
Recruitment Site (Count of Participants)
MSKCC	36 78.3%	37 78.7%	73 78.5%
MGH	10 21.7%	10 21.3%	20 21.5%
Marital Status (Count of Participants)
Married	38 82.6%	36 76.6%	74 79.6%
Single	5 10.9%	7 14.9%	12 12.9%
Divorced/Widowed	3 6.5%	4 8.5%	7 7.5%
Employment Status (Count of Participants)
Full Time	28 60.9%	23 48.9%	51 54.8%
Part Time	8 17.4%	9 19.1%	17 18.3%
On Leave	5 10.9%	4 8.5%	9 9.7%
Does not work	5 10.9%	11 23.4%	16 17.2%
Income (Count of Participants)
< $60,000	7 15.2%	10 21.3%	17 18.3%
$60,000-$139,999	17 37%	17 36.2%	34 36.6%
$140,000-$179,999	5 10.9%	6 12.8%	11 11.8%
>$180,000	14 30.4%	10 21.3%	24 25.8%
missing	3 6.5%	4 8.5%	7 7.5%

Outcome Measures

1. Primary Outcome

Title	Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants
Description	CPM knowledge is a 10-item multiple-choice measure developed by author Kirsten and Smith. Scores range from 0-100% correct with a higher score equaling more correct knowledge items. Items assessed understanding of the definition of CPM, surgical recovery time and risks/side effects, whether or not CPM improves survival, and whether CPM reduced the risk for disease progression. Will characterize the data using standard methods (estimated marginal means, standard errors, and Cohen's d effect sizes) separately by study arm. At follow-up scores will be reported as the difference between the knowledge score at two time points- the baseline knowledge score and follow-up knowledge score for both the CPM-DA arm and the UC arm.
Time Frame	2-4 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	39	44
Mean (Standard Error) [score on a scale]	62.47 (3.40)	51.33 (3.24)

2. Primary Outcome

Title	Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys
Description	Preparedness for the CPM decision was assessed using a 16-item scale adapted from the Ottawa Preparation for Decision Making scale modified to address the CPM decision. Items evaluated the amount of and satisfaction with information about CPM. Scores were reported as a mean across the items and ranged from 1-4 with 1 = Strongly Disagree; 2= Moderately Disagree; 3 = Moderately Agree; 4= Strongly Agree Higher scores = more prepared. Outcomes reported as estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions.
Time Frame	2-4 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	39	44
Mean (Standard Error) [score on a scale]	3.46 (.09)	3.42 (.08)

3. Primary Outcome

Title	Decisional Conflict Assessed by the Decisional Conflict Scale
Description	The Ottawa Decisional Conflict scale has 16 items and five subscales: support for the decision, uncertainty about the decision, level of relevant information, clarity of relevant values, and effective decision. Items are rated on a 5-point Likert scale (0= Strongly Disagree to 4 = Strongly Agree). Scores for the five subscales were calculated by an average that was multiplied by 25, which is recommended by the scale's developers. Thus, scores can range from 0 (no decision conflict) to 100 (high decision conflict). Higher scores indicate more decisional conflict.
Time Frame	2-4 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	39	44
Uncertainty	26.38 (3.50)	25.51 (3.23)
Informed	13.43 (1.96)	17.13 (1.81)
Values Clarity	15.50 (2.05)	20.76 (1.90)
Support	12.48 (2.51)	16.33 (2.33)
Effective Decision	9.65 (1.90)	12.46 (1.77)
Confidence in Decision	9.10 (0.35)	8.50 (0.33)

4. Secondary Outcome

Title	Self-Efficacy at 2-4 Week Follow up Survey
Description	Self-efficacy was a 3-item measure of confidence in the ability to manage worries and uncertainty about a possible recurrence of breast cancer, concerns about future surveillance, and worries about undergoing future surveillance. Results reported as Estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions. Scores were reported as the mean across the 3 items and ranged from 1 = Not at all confident; 2 = Somewhat confident; 3 = Moderately confident; 4 = Very confident; 5 = Extremely confident. Higher scores indicate more self-efficacy.
Time Frame	2-4 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	39	44
Mean (Standard Error) [score on a scale]	4.00 (0.16)	3.85 (.014)

5. Secondary Outcome

Title	Cancer Worry Assessed by 2-4 Week Follow-up Surveys
Description	Worry is measured by a single item that asks how worried the participant is about having another form of breast cancer on a four-point Likert scale 1= not at all worried and 4 = very worried. Higher scores indicate more worry. Results reported as estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions
Time Frame	2-4 week follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	39	44
Mean (Standard Error) [score on a scale]	2.91 (0.24)	2.84 (0.21)

6. Secondary Outcome

Title	CPM Motivations Assessed by Surveys
Description	Reasons for CPM were measured by an 11-item scale developed after a review of the qualitative and quantitative literature on motivations for CPM and interviews with women who chose or did not choose CPM. Scored were reported as a mean score across the 11 items. The scale was scored on a 1-4 scale from not at all important to Yes, extremely important and Higher score = more reasons/motivations. Outcomes reported as Estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions
Time Frame	2-4 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	39	44
Mean (Standard Error) [score on a scale]	2.77 (0.12)	2.73 (0.11)

7. Secondary Outcome

Title	Perceived Risk of Recurrence Assessed by 2 Items on Surveys
Description	Perceived risk was measured by two items. One item assessed contralateral breast cancer risk risk after unilateral mastectomy and radiation. The second item assessed perceived risk for chest wall recurrence after CPM. The first item asked "Out of 100 women with early breast cancer are treated with a single mastectomy or lumpectomy and radiation, about how many will develop breast cancer in the "other breast" in the 5 years after treatment? ___ women out of 100". The second item assessed risk for chest wall recurrence after bilateral mastectomy using the same scale 2. "If 100 women with early breast cancer have both breasts removed, how many will have breast cancer come back in the chest wall area of the "other breast" in the five years after treatment?". Outcomes reported as Estimated marginal means and standard errors for usual care and B-Sure decision aid conditions of the # out of 100 that women reported.
Time Frame	2-4 week follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	39	44
Risk for CBC after unilateral mastectomy/Radiation	6.44 (1.97)	5.10 (1.98)
risk for chest wall recurrence	11.95 (2.52)	12.12 (2.26)

8. Other Pre-specified Outcome

Title	User Interface Satisfaction Survey
Description	The scale has 27 items and four subscales: usefulness, ease of use, ease of learning, and satisfaction. Scales ranged from 1-7 with 1 being not at all or strongly disagree up to 7 being definitely or strongly agree.
Time Frame	2-4 week follow up

Outcome Measure Data

Analysis Population Description

Results provided for B-sure intervention arm only as usual care did not view or evaluate B-sure.

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	37	0
Overall Evaluation	5.63 (0.77)
Usefulness	4.92 (1.42)
Ease of use	6.03 (0.76)
Ease of learning	6.21 (0.96)
Satisfaction	5.56 (1.52)

9. Other Pre-specified Outcome

Title	B-Sure Use- Time
Description	Basic descriptive information will be gathered regarding the length of time modules are viewed. B-Sure use will be assessed by average time spent in B-Sure
Time Frame	2-4 week follow up

Outcome Measure Data

Analysis Population Description

Data reported is for participants in the B-Sure intervention arm only. The usual care participants did not receive the intervention.

Arm/Group Title	Arm I (Web-Based CPM-DA)	Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies	Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
Measure Participants	37	0
Mean (Full Range) [Minutes]	52.68

Adverse Events

Time Frame	6 Months.
Adverse Event Reporting Description	For the purposes of this study, an adverse event was defined as a participant experiencing any psychological distress, as reported by the patient to the study staff.
Arm/Group Title	Arm I (Web-Based CPM-DA)		Arm II (Usual Care)
Arm/Group Description	Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. Internet-Based Intervention: Receive web-based CPM-DA Survey Administration: Ancillary studies		Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM. Survey Administration: Ancillary studies
All Cause Mortality
	Arm I (Web-Based CPM-DA)		Arm II (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/47 (0%)
Serious Adverse Events
	Arm I (Web-Based CPM-DA)		Arm II (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Arm I (Web-Based CPM-DA)		Arm II (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		1/47 (2.1%)
Social circumstances
Participant reported distress to study staff	0/46 (0%)	0	1/47 (2.1%)	1

Limitations/Caveats

Future studies would benefit from a larger randomized trial including more minorities, lower education & income, & patients seen in community-based settings

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.