Effects of a time out consultation with the general practitioner on cancer treatment decision‐making: a randomised controlled trial

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

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Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-035337 ◽

2020 ◽

Vol 10 (1) ◽

pp. e035337 ◽

Cited By ~ 1

Author(s):

Joost Wolfs ◽

Jop Beugels ◽

Merel Kimman ◽

Andrzej A Piatkowski de Grzymala ◽

Esther Heuts ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Lymph Node ◽

Randomised Controlled Trial ◽

Conservative Treatment ◽

Cancer Treatment ◽

Controlled Trial ◽

Breast Cancer Treatment ◽

Randomised Controlled

IntroductionEarly breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective.Methods and analysisA multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume.Ethics and disseminationThe study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media.Trial registration numberNCT02790021; Pre-results.

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The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: A protocol for a cross-border pilot cluster randomised controlled trial

10.1101/2021.09.16.21263674 ◽

2021 ◽

Author(s):

Lisa Hynes ◽

Andrew W Murphy ◽

Nigel Hart ◽

Collette Kirwan ◽

Sarah Mulligan ◽

...

Keyword(s):

Primary Care ◽

Decision Making ◽

Pilot Study ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Definitive Trial ◽

Cluster Randomised ◽

Medication Reviews ◽

Randomised Controlled

AbstractBackgroundWhile international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically-informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)).MethodsA pilot cluster randomised controlled trial will be conducted, using a mixed methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention. A total of 16 practices will be recruited (eight in ROI; eight in NI) and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of GPs in ROI, and a GP and Practice Based Pharmacist (PBP) in NI. The GPs/GP and PBP will schedule time to review medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment, and 4- and 8-months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention, and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed.DiscussionThe findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies.Trial registrationRegistry: ISRCTN, ISRCTN80017020; Date of confirmation 4/11/2019; Retrospectively registered; http://www.isrctn.com/ISRCTN80017020.

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Variation in reported experience of involvement in cancer treatment decision making: evidence from the National Cancer Patient Experience Survey

British Journal of Cancer ◽

10.1038/bjc.2013.316 ◽

2013 ◽

Vol 109 (3) ◽

pp. 780-787 ◽

Cited By ~ 30

Author(s):

A El Turabi ◽

G A Abel ◽

M Roland ◽

G Lyratzopoulos

Keyword(s):

Decision Making ◽

Cancer Patient ◽

Cancer Treatment ◽

Patient Experience ◽

Treatment Decision ◽

Treatment Decision Making ◽

Experience Survey

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Shared decision-making in mental health care using routine outcome monitoring: results of a cluster randomised-controlled trial

Social Psychiatry and Psychiatric Epidemiology ◽

10.1007/s00127-018-1589-8 ◽

2018 ◽

Vol 54 (2) ◽

pp. 209-219 ◽

Cited By ~ 10

Author(s):

Margot J. Metz ◽

Marjolein A. Veerbeek ◽

Jos W. R. Twisk ◽

Christina M. van der Feltz-Cornelis ◽

Edwin de Beurs ◽

...

Keyword(s):

Mental Health ◽

Health Care ◽

Decision Making ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Shared Decision ◽

Cluster Randomised ◽

Outcome Monitoring ◽

Randomised Controlled

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The Significance of Patient-Reported Outcomes for Metastatic Breast Cancer Patients

Oncology Research and Treatment ◽

10.1159/000521826 ◽

2022 ◽

Author(s):

Larissa Elisabeth Hillebrand ◽

Ulrike Söling ◽

Norbert Marschner

Keyword(s):

Breast Cancer ◽

Decision Making ◽

Metastatic Breast Cancer ◽

Cancer Treatment ◽

Patient Reported Outcomes ◽

Metastatic Breast ◽

Treatment Decision ◽

Breast Cancer Patients ◽

Treatment Decision Making ◽

Patient Reported

Background: Breast cancer is still the most common malignancy in women worldwide. Once metastasized, breast cancer treatment primarily aims at reducing symptom burden, thereby trying to maintain and improve a patient´s quality of life (QoL), delaying disease progression, and prolonging survival. Curing the disease is not possible in the palliative setting. To better understand metastatic breast cancer patients, their symptoms and wishes, which are important for treatment-decision making and outcome, patient-reported outcomes (PROs) are of great importance, giving an impression of what really matters to and concerns a patient. Summary: Many advances have been made to implicate PROs in clinical trials, non-interventional studies, registries, and clinical routine care of metastatic breast cancer. For example, large phase III trials like PALOMA-3 (NCT01942135), MONALEESA-7 (NCT02278120), HER2CLIMB (NCT02614794), and KEYNOTE-119 (NCT02555657) trials implemented PROs in their trial design to assess the QoL of their trial patients. Also, non-interventional studies on metastatic breast cancer, like e.g., the NABUCCO study (IOM-02240), and prospective non-interventional, multicenter registries e.g., the tumor registry breast cancer (NCT01351584) or the breast cancer registry platform OPAL (NCT03417115), have implemented PROs to assess QoL during the anti-cancer treatment periods of the patients. Key Message: Using PROs in metastatic breast cancer can support shared treatment-decision making and management of symptoms, eventually leading to an improvement in QoL. Progressively, regulatory authorities take PROs into consideration for the approval of new drugs. Hence, the implication of PROs in cancer treatment, and especially in MBC, is of significant value.

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