Decision Support for Women With Breast Cancer

This study has been terminated.
(Lack of funds to continue and volunteer recruitment member left position)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01447771
First received: September 21, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

Breast cancer is a common malignancy among women in the United States. There are a variety of treatment decisions that need to be made. This study has been developed after a review of the literature demonstrated that women with breast cancer are making decisions regarding complex therapy issues in a way that is not congruent with their decision-making control preference.

Some patients want to be empowered with information so that they can actively participate in the decision making about their care; others want to rely on the recommendations made by the oncologist. This is important because patients who were not satisfied with their adjuvant treatment decision noted a negative effect on quality of life and self image. These patients had more difficulties with treatment side effects; including aches, hot flashes, pain, and mood alteration. In additions the Institute of Medicine recommended that patient centeredness be a key aim of health care organizations and that all patients be given the opportunity to exercise the degree of control they choose over health care decisions that affect them.

It is hypothesized that women making decisions regarding adjuvant therapy who are supported to make decisions based on their preferred level of control will have positive psychological outcomes.


Condition Intervention
Breast Neoplasms
Behavioral: Decision control preference scale

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Decision Support for Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Satisfaction with Decision at 24 hours [ Time Frame: 24 hours after consultation ] [ Designated as safety issue: No ]
    Satisfaction with Decision (SWD) scale: A 6 item tool with a 5-point Likert scale ranging from 1, "strongly disagree" to 5, "strongly agree", will be used to evaluate the patient's satisfaction with decision involvement by phone within 24 hours following the consultation and repeated 4 weeks later. This instrument is based on the Satisfaction with Decision Instrument of Holmes-Rovner. The SWD scale performed reliability, Cronbach's alpha = 0.86

  • Satisfaction with Decision at 4 weeks [ Time Frame: 4 weeks after consultation ] [ Designated as safety issue: No ]
    Satisfaction with Decision (SWD) scale: A 6 item tool with a 5-point Likert scale ranging from 1, "strongly disagree" to 5, "strongly agree", will be used to evaluate the patient's satisfaction with decision involvement by phone within 24 hours following the consultation and repeated 4 weeks later. This instrument is based on the Satisfaction with Decision Instrument of Holmes-Rovner. The SWD scale performed reliability, Cronbach's alpha = 0.86


Secondary Outcome Measures:
  • Baseline Depression Score [ Time Frame: Baseline before consultation ] [ Designated as safety issue: No ]
    This scale will be used to measure depressive symptoms. The CSES-D 10 is a 10-item brief version of a self-report questionnaire developed by the Center for Epidemiologic Studies at the National Institute of Mental Health for use in studies of depression in community samples. The CSES-D 10 version has been used across multiple populations. It has been shown to have test-retest reliability of 0.80 in patients with GI cancer.

  • Baseline Impact of Event Score [ Time Frame: Baseline, before consultation ] [ Designated as safety issue: No ]
    A 15-item Likert scale ranging from total scores of 0 to 75 with levels of: 9-25 indicative of moderate adaptation difficulties and > 26 is considered indicative of clinical adaptation difficulties. Intrusion (the extent to which individuals are overwhelmed by thoughts and feelings of breast cancer, 7 items) and avoidance (the tendency to avoid thoughts and feelings about breast cancer, 8 items) are subscales. In this study, it will be used to measure patient distress in participating in health care decision making. The Cronbach's alpha for patients with GI cancer was 0.86.

  • Depression Score at 4 weeks [ Time Frame: 4 weeks after consultation ] [ Designated as safety issue: No ]
    This scale will be used to measure depressive symptoms. The CSES-D 10 is a 10-item brief version of a self-report questionnaire developed by the Center for Epidemiologic Studies at the National Institute of Mental Health for use in studies of depression in community samples. The CSES-D 10 version has been used across multiple populations. It has been shown to have test-retest reliability of 0.80 in patients with GI cancer.

  • Impact of Event score at 24 hours [ Time Frame: 24 hours after consultation ] [ Designated as safety issue: No ]
    A 15-item Likert scale ranging from total scores of 0 to 75 with levels of: 9-25 indicative of moderate adaptation difficulties and > 26 is considered indicative of clinical adaptation difficulties. Intrusion (the extent to which individuals are overwhelmed by thoughts and feelings of breast cancer, 7 items) and avoidance (the tendency to avoid thoughts and feelings about breast cancer, 8 items) are subscales. In this study, it will be used to measure patient distress in participating in health care decision making. The Cronbach's alpha for patients with GI cancer was 0.86.

  • Impact of Event Score at 4 weeks [ Time Frame: 4 weeks after consultation ] [ Designated as safety issue: No ]
    A 15-item Likert scale ranging from total scores of 0 to 75 with levels of: 9-25 indicative of moderate adaptation difficulties and > 26 is considered indicative of clinical adaptation difficulties. Intrusion (the extent to which individuals are overwhelmed by thoughts and feelings of breast cancer, 7 items) and avoidance (the tendency to avoid thoughts and feelings about breast cancer, 8 items) are subscales. In this study, it will be used to measure patient distress in participating in health care decision making. The Cronbach's alpha for patients with GI cancer was 0.86.

  • Congruence between preferred and actual decision making control at 24 hours [ Time Frame: 24 hours after consultation ] [ Designated as safety issue: No ]
    This is a yes/no answer to determine congruence between actual and preferred level of decision making control. Descriptive analysis of the results will be preformed

  • Congruence between preferred and actual decision making control at 4 weeks [ Time Frame: 4 weeks after consultation ] [ Designated as safety issue: No ]
    This is a yes/no answer to determine congruence between actual and preferred level of decision making control. Descriptive analysis of the results will be preformed

  • Baseline Impact of Event Score [ Time Frame: Before consultation ] [ Designated as safety issue: No ]
    A 15-item Likert scale ranging from total scores of 0 to 75 with levels of: 9-25 indicative of moderate adaptation difficulties and > 26 is considered indicative of clinical adaptation difficulties. Intrusion (the extent to which individuals are overwhelmed by thoughts and feelings of breast cancer, 7 items) and avoidance (the tendency to avoid thoughts and feelings about breast cancer, 8 items) are subscales. In this study, it will be used to measure patient distress in participating in health care decision making. The Cronbach's alpha for patients with GI cancer was 0.86.


Enrollment: 14
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Decision control preference intervention
Behavioral: Decision control preference scale
At time 1, participants in the intervention group will be asked to complete the Decision Control Preference Scale.The range of decision control is measured by the Decision Control Preference (DCP) Scale. The scale is used to measure the preferred or actual role in decision making using five response statements: two represent an active or patient-controlled role, one a shared or collaborative role, and two represent a passive or provider-controlled role. The preferred level of decision making control will be known by the participant in the intervention group and the information given to the oncologist prior to the consultation regarding adjuvant therapy
Other Name: DCP scale

Detailed Description:

This evidence based study has been developed after a review of the literature demonstrated that 14 - 58% of women with breast cancer are making decisions regarding complex therapy issues in a way that is not congruent with their decision-making control preference. Because of the prevalence of decision-making control preference incongruence and strong evidence that providing support for a woman's decision making control preference is related to quality of life measures, this study will test the implementation of a nursing intervention to support the decision making of women with breast cancer. Using sample randomization with assignment to one of two groups, this study will explore whether using Degner's Control Preference (DCP) Scale supports decision making control preferences in women who are making decisions about breast cancer treatment. Results of the study will guide implementation of sustainable evidence-based behavioral practices that can have significant effects on quality of care outcomes.

This study will assess satisfaction with decision involvement, depression, and decision making distress in women with early stage breast cancer after a decision support intervention to support a woman's preferred decision control preference. It is hypothesized that a decision support intervention that consists of providing information from the Degner Control Preference (DCP) Scale to the provider and patient will have a positive effect on psychological outcomes (decision satisfaction, decision making distress, and depression) in women making decisions about breast cancer treatment. Testing the effect of the decision support intervention on decision satisfaction, decision making distress and depression will be measured using t-Tests.

Patients with early stage breast cancer who are scheduled to have a medical oncology consultation, to decide an adjuvant therapy regimen, will be asked to participate.

128 patients will be randomly assigned to a group in which the patient and their oncologist would know the patient's preferred level of decision making control (intervention group) or a group that would receive information about a balanced diet (attention control group). Two nurses on the research team will consent participants, participate in the intervention, and collect data through interviews. Post intervention interviews will occur within 24 hours of the intervention and 4 weeks later.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with early stage (Stage I and Stage II) breast cancer that are considering adjuvant therapy and are being evaluated at the Johns Hopkins Avon Foundation Breast Center.
  2. Age 18 years and older.
  3. Able to read and speak English.

Exclusion Criteria:

  1. Severe visual impairments that would make it difficult to read study instruments or inability to read.
  2. Lack of capacity to provide informed consent to participate in the study.
  3. Patients being seen for a second opinion.
  4. Patients with a history of previous neoadjuvant chemotherapy.
  5. Women who are pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447771

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Sharon Olsen, PhD Johns Hopkins University School of Nursing
  More Information

Publications:
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01447771     History of Changes
Other Study ID Numbers: NA00046799, J1158
Study First Received: September 21, 2011
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Decision making
Decisional aide

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014