A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.
Results support the effectiveness of providing a single-session group psychoeducational intervention as a first-step approach to supportive care for women at the end of breast cancer treatment.
The feasibility and acceptability of HHH-G was supported, and treatment outcomes suggest the potential benefits of the intervention. Phase III evaluation of HHH-G program is warranted.
The present analyses were conducted to examine demographic and clinical variables associated with mood and health-related distress in a sample of 440 women completing primary treatment for early-stage breast cancer. The authors' aim was to test the hypothesis that higher levels of self-efficacy and perceived preparedness for the end of treatment--the reentry phase--are associated with better mood and lower health-related distress in this sample. Women who had received chemotherapy and who were younger (<50 years) had significantly higher mood disturbance and health-related distress scores. Younger age, preparedness, and self-efficacy predicted 36% of the variance in mood disturbance scores. Self-efficacy and age predicted 26% of the variance in health-related distress. Although further research is needed, our findings suggest that self-efficacy and perceived preparedness represent important constructs to target in the development of interventions for women at the reentry transition.
Background
Whether to undergo postmastectomy breast reconstruction (PMBR) is a challenging, preference-sensitive decision. It is therefore paramount to optimize decision quality through ensuring patients' knowledge and aligning treatments with their personal preferences. This study assessed the effects of a preconsultation educational group intervention (PEGI) on patient knowledge, state-trait anxiety, and decisional conflict (patient uncertainty in decision making) during the decision-making process.
Methods
This phase 3 randomized controlled trial assessed effects of a PEGI in women without active breast cancer undergoing delayed PMBR, or prophylactic mastectomy with immediate PMBR. Both groups underwent routine education before consultation. In addition, the intervention group underwent a PEGI composed of presentations from a plastic surgeon and nurse, a value clarification exercise, and shared experiences from PMBR patients before the consultation with the plastic surgeon. Before and 1-week after consultation, outcome measures were assessed using the Decisional Conflict Scale, State-Trait Anxiety Inventory, and the BREAST-Q.
Results
Of the 219 women deemed eligible, a total of 156 women were recruited and randomized. Treatment fidelity was 96% and retention was 88%. At baseline, there were no significant differences in terms of demographic or clinical status, knowledge, state-trait anxiety, and decisional conflict. Patient knowledge about PMBR improved in both groups; however, the degree of knowledge attainment was significantly greater in the PEGI group (24.5% improvement in the intervention group compared with 13.5% in the routine education group,
P
< 0.001). The reduction in decisional conflict from baseline to follow-up was greater in the intervention group compared with the routine education; however, the difference only approached significance (
P
= 0.09).
Conclusions
The provision of a preconsultation educational group intervention has been shown to significantly close the knowledge gap on PMBR in patients seeking delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction compared with routine education alone.
The diagnosis of breast cancer significantly affected the male partners, creating the need for support services including information on a variety of topics. An information binder tailored specifically to their needs was the preferred method of facilitating their husbandly role and coping. Findings did not support the clinical assumption that men would be interested in a men's group focused on them and their needs.
BackgroundThe Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.Methods/designThis is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada.Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired.Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.DiscussionOur pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.Trial registrationNCT01857882
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