Decision Support for Women With Breast Cancer

NCT01447771 | Terminated DMC

• 2 other identifiers: NA00046799J1158
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms

Keywords

Decision making; Decisional aide

Outcome Measures

Primary Outcomes (2)

• Satisfaction with Decision at 24 hours

  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

  24 hours after consultation

• Satisfaction with Decision at 4 weeks

  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

  4 weeks after consultation

Secondary Outcomes (8)

• Baseline Depression Score

  Baseline before consultation

• Baseline Impact of Event Score

  Baseline, before consultation

• Depression Score at 4 weeks

  4 weeks after consultation

• Impact of Event score at 24 hours

  24 hours after consultation

• Impact of Event Score at 4 weeks

  4 weeks after consultation

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

Decision control preference intervention

Behavioral: Decision control preference scale

Interventions

Decision control preference scale BEHAVIORAL

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

Also known as: DCP scale

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 18 years and older.
• Able to read and speak English.

You may not qualify if:

• Severe visual impairments that would make it difficult to read study instruments or inability to read.
• Lack of capacity to provide informed consent to participate in the study.
• Patients being seen for a second opinion.
• Patients with a history of previous neoadjuvant chemotherapy.
• Women who are pregnant.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (6)

• Degner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau B, Watson P, Mueller B. Information needs and decisional preferences in women with breast cancer. JAMA. 1997 May 14;277(18):1485-92.

  PMID: 9145723 BACKGROUND

• Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.

  PMID: 9505581 BACKGROUND

• Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.

  PMID: 8717600 BACKGROUND

• Lo SS, Mumby PB, Norton J, Rychlik K, Smerage J, Kash J, Chew HK, Gaynor ER, Hayes DF, Epstein A, Albain KS. Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol. 2010 Apr 1;28(10):1671-6. doi: 10.1200/JCO.2008.20.2119. Epub 2010 Jan 11.

  PMID: 20065191 BACKGROUND

• Hack TF, Degner LF, Watson P, Sinha L. Do patients benefit from participating in medical decision making? Longitudinal follow-up of women with breast cancer. Psychooncology. 2006 Jan;15(1):9-19. doi: 10.1002/pon.907.

  PMID: 15669023 BACKGROUND

• Shaha M, Cox CL, Talman K, Kelly D. Uncertainty in breast, prostate, and colorectal cancer: implications for supportive care. J Nurs Scholarsh. 2008;40(1):60-7. doi: 10.1111/j.1547-5069.2007.00207.x.

  PMID: 18302593 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sharon Olsen, PhD

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

US (1)