Group medical consultations (GMCs) and tablet-based online support group sessions in the follow-up of breast cancer: A multicenter randomized controlled trial.

OBJECTIVE: Group medical consultations (GMCs) provide individual medical visits in the presence of ≤7 peer-patients. In the follow-up of breast cancer, we evaluated the efficacy of a new type of blended care My-GMC, a GMC combined with a tablet-based online app, consisting of three online support group sessions (SGS) and additional information. METHODS: This randomized controlled trial compared the effect of My-GMC (n = 59) with one individual medical visit (n = 50) (care as usual). Between-group differences on the outcomes distress and empowerment were analyzed 1 week, 3 and 6 months after the visit. RESULTS: No between-group differences were found for the primary outcomes distress and empowerment. More themes were discussed in GMCs compared to individual visits. Significantly more patients experienced peer-support in GMCs (78%) than via the online app (29%). Satisfaction with the online app was low. CONCLUSIONS: My-GMC did not result in improvements in distress or empowerment, which might partly be explained by low baseline distress levels. This paper provides valuable information concerning factors on organizational level as well as individual level influencing the evaluation of a blended care intervention. PRACTICE IMPLICATIONS: My-GMC provided an innovative alternative, combining professional and peer-support in face-to-face and online SGS, resulting in additional information provision and peer-support. Further improvement of the apps is needed to improve user satisfaction. NETHERLANDS TRIAL REGISTER: NTR3771.

Determinants of adherence to recommendations for cancer prevention among Lynch Syndrome mutation carriers: A qualitative exploration.

BACKGROUND: Lynch Syndrome (LS) mutation carriers are at high risk for various cancer types, particularly colorectal cancer. Adherence to lifestyle and body weight recommendations for cancer prevention may lower this risk. To promote adherence to these recommendations, knowledge on determinants of adherence in LS mutation carriers is needed. Therefore, this study aimed to identify determinants of adherence to lifestyle recommendations for cancer prevention in LS mutation carriers. METHODS: Five focus groups were conducted with DNA confirmed LS mutation carriers (n = 29). Transcripts were analyzed by thematic analysis, using the Health Belief Model (HBM) as a theoretical framework. RESULTS: Tolerance of an unhealthy lifestyle because of the desire to enjoy life and avoidance of LS dominating their life were most frequently reported as important barriers of adherence to the recommendations. Most important facilitators of adherence to the recommendations were enhancement of wellbeing and intolerance of unhealthy foods due to colon surgery. CONCLUSIONS: This study provided a comprehensive overview of determinants of adherence to recommendations for cancer prevention. These determinants, of which some are typically and unique for LS mutation carriers, can be used to design a lifestyle intervention that meets the needs of LS mutation carriers.

Cardiac monitoring during adjuvant trastuzumab therapy: Guideline adherence in clinical practice.

BACKGROUND: Cardiotoxicity is an important adverse effect of adjuvant breast cancer treatment with trastuzumab and three monthly left ventricular ejection fraction (LVEF) monitoring is considered mandatory. The purpose of this study was to gain insight into LVEF monitoring during adjuvant trastuzumab treatment in clinical practice. MATERIAL AND METHODS: In a multicenter retrospective study encompassing 328 patients, of which 171 patients were actually treated with trastuzumab, we analyzed the frequency and mode of LVEF monitoring and compared it with LVEF monitoring guidelines. RESULTS: The results indicated poor guideline adherence. In 9% of patients trastuzumab was started in spite of a low LVEF (< 55%). In 24% of patients no valid baseline LVEF value was available. LVEF measurements during treatment at three, six and 12 months were only performed in, respectively, 53%, 40% and 30% of patients. CONCLUSION: A significant proportion of patients are treated with trastuzumab, while LVEF monitoring is not adequately performed. More attention should be paid to the implementation of (cardiac assessment) guidelines in clinical practice.

Peer support and additional information in group medical consultations (GMCs) for BRCA1/2 mutation carriers: A randomized controlled trial.

BACKGROUND: Group medical consultations (GMCs) provide individual medical visits in the presence of ≤ 7 peer- patients. This study evaluated the efficacy of GMCs in the yearly breast cancer surveillance of BRCA mutation carriers. MATERIAL AND METHODS: This randomized controlled trial compared GMCs (intervention group, n = 63) with individual medical visits (control group, n = 59). Between-group differences on the primary outcomes distress and empowerment, were analyzed one week and three months after the visit. Feasibility is evaluated in terms of demand, acceptability and practicability. RESULTS: No between-group differences were found on primary outcomes. More themes were discussed in GMCs. Seventy-five percent of GMC-participants experienced peer support. Carriers reported significantly higher satisfaction with individual visits. GMCs were less time-efficient. CONCLUSION: This is the first GMC study which reports results in favor of individual visits. The hereditary nature of the condition differentiates our study population from earlier studied GMC groups. Even though most participants experienced peer support and received more information, the lower patient satisfaction may be explained by the lack of individual time with the clinician and disruption of normal surveillance routines. As the need for peer support and additional information is present in a substantial part of carriers, future research should study the process of peer support.

Breast self-examination education for BRCA mutation carriers by clinical nurse specialists.

PURPOSE: Breast self-examination (BSE) may be beneficial for women with a BRCA1 or BRCA2 mutation. Therefore, these women are often advised to perform BSE. However, only 20% to 35% is performing BSE monthly, and proficiency levels are low. Recently diagnosed carriers are educated by a specially trained clinical nurse specialist (CNS) on how to perform BSE, as part of the yearly surveillance. Clinical nurse specialists are already commonly involved in breast cancer care. However, CNSs are not yet involved in the counseling of BRCA mutation carriers. The aim of this RCT was 2-fold: (1) to evaluate the feasibility of CNS-led BSE education (based on the Health Belief Model) as part of BRCA surveillance and (2) to evaluate the effects and feasibility of additional written information leaflets concerning BSE. METHODS: Thirty-seven female BRCA1 or BRCA2 mutation carriers were randomized into the intervention or control group. Women in both groups were educated about BSE by a specially trained CNS during the yearly visit to the outpatient clinic. The intervention group received additional written BSE instructions. After 3 months, 29 patients filled out a questionnaire, covering demographic characteristics, BSE behavior, and patient satisfaction. RESULTS: The BSE frequencies did not significantly differ between both groups. A significant increase in the self-reported frequency of BSE after CNS-led education (P < .001) was shown. Before the education, the main reason for not performing BSE was that women had felt unable to perform BSE (42.9%). Patient satisfaction with the CNS-led education was high. CONCLUSION: CNS-led BSE education is feasible for the yearly breast surveillance of BRCA mutation carriers. In addition, a leaflet was shown to be useful as an additional source of information for patients. IMPLICATIONS: These results indicate that it is feasible to involve a CNS in the yearly surveillance of BRCA mutation carriers, which could be a solution for the continuous increased demand for care, while providing continuing high-quality care.

Group medical consultations in the follow-up of breast cancer: a randomized feasibility study.

PURPOSE: Group medical consultations (GMCs) provide individual medical visits conducted within a group of four to eight peer patients. This study evaluated the feasibility and efficacy of GMCs in the follow-up of breast cancer. METHODS: In this randomized controlled trial, 38 patients participated in a single GMC (intervention group), while the control group (n = 31) received individual outpatient visits. Feasibility is measured in terms of acceptability, demand, practicability and costs, integration and implementation, and efficacy. Between-group differences on the efficacy outcomes distress (SCL-90) and empowerment (CEQ), 1 week and 3 months after the visit, were analyzed using ANCOVAs. RESULTS: GMCs scored high on most areas of feasibility. Patients in GMCs and individual visits were equally satisfied. Patients and professionals reported more discussed themes in GMCs, despite no between-group differences on information needs prior to the visit. Sixty-nine percent of GMC patients experienced peer support. Costs for GMCs were higher compared to individual visits. However, involving a clinical nurse specialist (CNS) instead of a medical specialist reduced costs to the level of individual CNS care. Efficacy outcomes (distress and empowerment) were equal in both groups. CONCLUSION: GMCs in this study were feasible. Further optimization of GMCs in future (cost-)effectiveness trials is possible by increasing the frequency of GMCs, stating criteria for the type of professionals, number of patients involved, and time limits. IMPLICATIONS FOR CANCER SURVIVORS: BCS may benefit from GMCs by receiving more information and additional peer support. GMCs cover all aspects of follow-up and may be a good alternative for individual follow-up.

Group medical visits in the follow-up of women with a BRCA mutation: design of a randomized controlled trial.

BACKGROUND: BRCA mutation carriers have a 40-80% life-time risk of developing breast cancer. They may opt for yearly breast cancer surveillance or for prophylactic mastectomy. Both options show increased survival rates. It is a complex choice to be made between these two options. As a result most women experience high levels of distress and high needs for information. To fulfill the needs for psychosocial support and information we have introduced group medical consultations (GMCs). A GMC provides individual medical visits conducted within a group. This 90 minute group-visit with 8-12 patients gives patients the opportunity to spend more time with their clinician and a behavioral health professional and learn from other patients experiencing similar topics. However, it should be noted that group sessions may increase fear in some patients or influence their decision making. METHODS/DESIGN: In this randomized controlled trial, 160 BRCA mutation carriers diagnosed maximally 2 years ago are recruited from the Radboud University Nijmegen Medical Centre. Participants are randomized in a 1:1 ratio to either the GMC intervention group (onetime participation in a GMC instead of a standard individual visit) or to a usual care control group. Primary outcome measures are empowerment and psychological distress (SCL 90). Secondary outcome measures are fear of cancer, information needs before the consultation and the received information, self-examination of the breasts, patient satisfaction, quality of life and cost-effectiveness. Data are collected via self-reported questionnaires 1 week before the visit, and at 1 week and at 3 months follow-up. A pilot study was conducted to test all procedures and questionnaires. DISCUSSION: The possibility for interaction with other BRCA mutation carriers within a medical visit is unique. This study will assess the effectiveness of GMCs for BRCA mutation carriers to improve empowerment and decrease distress compared to individual visits. If GMCs prove to be effective and efficient, implementation of GMCs in regular care for BRCA mutation carriers will be recommended.