Clinical trial NCT01447771: Decision Support for Women With Breast Cancer
Official title: Decision Support for Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Decision making
Decisional aide
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Satisfaction with Decision at 24 hours
timeFrame: 24 hours after consultation
measure: Satisfaction with Decision at 4 weeks
timeFrame: 4 weeks after consultation
Secondary outcomes:
measure: Baseline Depression Score
timeFrame: Baseline before consultation
measure: Baseline Impact of Event Score
timeFrame: Baseline, before consultation
measure: Depression Score at 4 weeks
timeFrame: 4 weeks after consultation
measure: Impact of Event score at 24 hours
timeFrame: 24 hours after consultation
measure: Impact of Event Score at 4 weeks
timeFrame: 4 weeks after consultation
measure: Congruence between preferred and actual decision making control at 24 hours
timeFrame: 24 hours after consultation
measure: Congruence between preferred and actual decision making control at 4 weeks
timeFrame: 4 weeks after consultation
measure: Baseline Impact of Event Score
timeFrame: Before consultation
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Sharon Olsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
citation: 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.
citation: 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.
citation: 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.
citation: 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.