Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

Disease Attributes

Patient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment.

Patients will receive usual care after completion of primary breast cancer treatment.

Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.

Mini-AFTERc

Gerry M Humphris, PhD

Calum T McHale, PhD

People treated for breast cancer often live with an ongoing fear that the cancer will recur. This fear may develop and impact on their mental health and quality of life. The Mini-AFTERc study is a pilot trial of a brief cognitive behavioural communication intervention, designed to reduce fear of cancer recurrence (FCR) in breast cancer patients. This pilot trial aims to determine the acceptability and practicality of introducing the Mini-AFTERc intervention into everyday practice, and inform the development of a full randomised controlled trial.

The objectives of this pilot trial are as follows:

1. To develop a procedure for training breast cancer nurses (BCN) in the delivery of the Mini-AFTERc intervention and introduce the intervention into current NHS service provision for breast cancer patients.
2. To collect data to pilot and test recruitment (of breast cancer nurses and breast cancer patients), the fidelity of intervention elements, the acceptability to participants (primary and secondary outcomes) and detailed economic indicators for a full trial.
3. Apply a formal decision making framework (ADePT) to determine a profile of factors to reveal potential difficulties and appraise solutions prior to a full trial.

This study is a multicentre controlled pilot trial of the Mini-AFTERc intervention and will take place in 4 breast cancer centres in NHS Scotland health boards, including Fife, Highlands, Lothian and Tayside. Two centres will deliver the intervention (Fife and Lothian) and 2 centres will deliver usual care to patients, acting as control centres (Highlands and Tayside). The project will be delivered in 3 phases:

Phase 1 will include the development and delivery of the Mini-AFTERc intervention training package for breast cancer nurses.

Phase 2 will include patient recruitment and data collection. There will be 2 intervention centres and 2 control centres across NHS Scotland. Patients who have completed their primary breast cancer treatment, will be screened for moderate FCR (scoring ≥10 and \<15 on the Fear of Cancer Recurrence 4-item Scale; FCR4). Breast cancer nurses will deliver the intervention by telephone in intervention centres, which will be audio recorded. Patients will complete a satisfaction questionnaire after the intervention (CARE and MISS). Follow-up questionnaires measuring fear of cancer recurrence, anxiety and depression and quality of life outcomes (FCR4, HADS, EQ-5D) will be delivered via a smartphone app at 2 weeks, 1 month and 3 months following intervention or 3 weeks, 5 weeks and 13 weeks following screening for the control group. Semi-structured interviews with 20% of patients and all nurses will be conducted to assess experiences and acceptability of the intervention.

Phase 3 will conduct data analysis and trial evaluation. Screening and follow-up data will be quantitatively analysed, including structured equation modelling. Interviews will be subject to framework analysis based on normalisation process theory (NPT). The pilot trial will be systematically evaluated using a process of decision making after pilot and feasibility trials (ADePT).

The findings will help to understand if this brief intervention can be implemented in everyday practice and can reduce FCR. They will also inform the practicality of implementation of a larger-scale randomised trial.

Mini-AFTERc Intervention for Fear of Cancer Recurrence

A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients

Assessed using the Consultation and Relational Empathy (CARE) measure, validated for use in secondary care (Mercer et al. 2004). The CARE measure asks patient to rate their nurses' communication skills on 10 communication and empathy domains (e.g. 'How was your nurse at fully understanding your concerns?'). Patients rate nurses from 1 ('Poor') to 5 ('Excellent') for each of the 10 domains.

The FCR4 is a 4-item measure designed to assess patient anxiety, worry and strong feelings associated with the return of cancer (e.g. 'I am afraid that my cancer may recur'). The research group has validated the FCR4 as an accurate measure of cancer recurrence fears in breast cancer patients that is fit for routine use in clinical services (Humphris, Watson, Sharpe, \& Ozakinci, 2018). Each question in the FCR4 is rated by the patient on a scale of 1 ('Not at all') to 5 ('All the time'). A cumulative score of ≥10 (60 Percentile) across all 4 items is defined as 'moderate' fear of cancer recurrence and a cumulative score of ≥15 is defined as 'high' fear of cancer recurrence.

The HADS is a 14-item assessment tool used to screen for anxiety and depression the general medical population (Zigmond \& Snaith, 1983). The HADS is well established tool and has been employed in a multitude of medical settings, including oncology, to assess patients' mental health (Hartung et al., 2017; Vodermaier \& Millman, 2011). The HADS assesses two domains, depressionand anxiety. Patients report symptoms of depression and anxiety in the last week on a 4-point Likert scale, from 0 (e.g. "Not at all") to 3 (e.g. "Most of the time").

The EQ-5D is a standardised instrument of health-related quality of life, developed by the EuroQol Group (Herdman et al., 2011). The EQ-5D assesses 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D contains 6-items, 5 of these items assess each of the 5 dimensions and are rated on a 5-level (5L) scale. The final item is a measure of health state, which is rated on a scale of 0 ('worst imaginable health state') to 100 (Best imaginable health state').

Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of breast cancer nurses. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).

Assess number of patients recruited at each site, including those who decline to participate.

Assess number of patients who complete the trial.

Assess number of patients who do not complete the trial, withdraw or drop-out.

Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of patients. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).

University of Stirling

University of Surrey

Swansea University

Chief Scientist Office of the Scottish Government

University of St Andrews

Professor of Health Psychology

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

When a patient is identified as consuming alcohol above CCS guidelines (based on mandatory baseline questionnaire) the practitioner in Group A will not receive computer alerts but will still have access to the alcohol consumption data as part of the baseline assessment (Screening). Healthcare providers will have access to all the same resources available as the intervention clinic (Treatment as usual).

When a patient is identified as consuming alcohol above CCS guidelines (based on mandatory baseline questionnaire) the practitioner in Group B will receive computer alerts (Screening). The alert will provide a 5 minute script (Brief Intervention) for the health care providers to relay to patients and the ability to print or email a self-help resource to the patient each time the patient visits (Referral to Treatment).

The intervention is a clinical decision support system (CDSS) that provides a computerized prompt in the clinic's online portal. The CDSS prompts a practitioner to intervene when a patient is screening above recommended drinking guidelines. The prompt appears as an alert message, recommending intervention. The portal suggests scripted brief intervention language, designed based on the College of Family Physicians of Canada and Canadian Centre on Substance Abuse's resource on conducting evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) guidelines.

Brief alcohol intervention

Peter Selby, MBBS CCFP FCFP MHSc DipABAM

Tobacco and alcohol use present multiplicative risk for aerodigestive cancers. Reducing alcohol consumption improves smoking cessation outcomes and reduces cancer risk. Risky alcohol consumption and smoking are often treated separately despite concurrent treatment potentially leading to better outcomes for each. However, no rapidly scalable program exists for combined interventions in primary care clinics spread across wide geographic areas. This cluster randomized trial aims to report on the effects of a novel clinical decision support system (CDSS) on intervention rates by primary care practitioners addressing risky alcohol use in a smoking cessation program.

The investigators will be implementing a clinical decision support system (CDSS) in 221 primary care sites participating in the Smoking Treatment for Ontario Patients (STOP) program across Ontario, Canada. Sites will be blindly allocated to one of two clinical decision support systems guiding practitioners to provide a risky alcohol use intervention to smokers attempting to quit using nicotine replacement therapy (NRT). Risky alcohol use is defined as drinking above the Canadian Cancer Society's low-risk drinking guidelines. Primary analysis will measure the proportion of risky drinkers offered an alcohol intervention in each CDSS arm at baseline. Patients will be contacted by phone or email to track smoking cessation and alcohol consumption rates at 6- and 12-month follow up.

Upon completion of the trial, the effect of different clinical decision support systems on practitioner behavior, and on client tobacco and alcohol use, will be discussed. If the CDSS successfully promotes SBIRT for risky alcohol use in a primary care setting and/or improves patient-level outcomes, including smoking cessation rates and alcohol use reduction, this tool can be used as a model for other web-based behavior change interventions integrated into primary care practice.

Background: Primary care providers work in busy settings responding to a variety of acute and chronic problems. Implementing even brief evidence-based interventions for cancer risk behaviors, such as tobacco smoking and excess alcohol consumption, is sub-optimal due to time and knowledge constraints. These behaviors cluster in the same person and confer a multiplicative, positively associated risk for aero-digestive cancers but are often addressed separately, if at all, despite alcohol consumption undermining smoking cessation. Processes that reduce time and effort and yet increase practitioner effectiveness show promise to increase adoption of such practices. Computerized clinical decision support systems (CDSS) within practices allow for prompt procedural knowledge for practitioners, simplifies the decision-making process, and provides recommendations for patient care.

The initiation of the STOP Program (Smoking Treatment for Ontario Patients - an Ontario-wide initiative providing smoking cessation to eligible smokers who wish to quit), has demonstrated that such a system allows for rapid adoption of smoking cessation interventions in primary care with 189 sites (80% of eligible sites) in Ontario treating 40,000 smokers in 2 years. Approximately 36% consume alcohol above Canadian Cancer Society (CCS) guidelines (less than one drink per day for women; less then two drinks per day for men; no engagement in binge drinking) and those that do have a lower quit rate.

A combined alcohol and tobacco intervention delivered systematically using such a platform has never been studied before, which constitutes a missed opportunity to simultaneously address two closely related risk factors for cancer. Thus, implementation of a CDSS within the daily clinical workflow is a novel concept for cancer prevention with high potential to address the lack of brief interventions by health care providers.

Objective: Assess the effectiveness of a CDSS to increase the rates of brief alcohol intervention by healthcare providers and to reduce alcohol consumption in adult smokers making a quit attempt.

Methodology: Organizations from the STOP Program will be randomly allocated (1:1) to Group A or Group B.

Patient Population: Adult consenting smokers of the STOP Program identified as drinking above the sex-specific cut off at baseline will be eligible for the intervention.

Intervention: Half the sites will have a computer prompt built into STOP's data collection system, which will appear for any participant identified as drinking above the sex-specific cut off at baseline (Group A). The reminder will provide the practitioners with a five minute script advising their patient to reduce alcohol consumption to increase their chances of quitting smoking, and will be prompted to provide a self-help booklet to reduce alcohol intake. Sites without the prompt (Group B) will not receive reminders but will have access to the same resources.

Organizations will be randomly allocated in a 1:1 allocation ratio to Group A (Test) or Group B (Control) accounting for rurality, organization type, practice size and academic affiliation.

Personalized Alerts and Care Pathways to Prompt Prevention Interventions for Alcohol and Tobacco Users in Primary Care

Personalized Patient Alerts and Care Pathways to Prompt Prevention Interventions for Combined Alcohol and Tobacco Users in Primary Care

The study's primary outcome is the proportion of health practitioners who offer the brief alcohol intervention (with educational resource) to eligible patients.

The study's secondary outcome is the proportion of health practitioners who deliver the brief alcohol intervention (with educational resource) to eligible patients (patient accepts practitioner's offer of intervention).

The study's tertiary outcome is the proportion of eligible participants who report being abstinent from smoking and meet CCS alcohol guidelines at follow-up.

Canadian Cancer Society (CCS)

Centre for Addiction and Mental Health

Director, Medical Education

20-30 minute structured conversation with breast cancer patient using Mini-AFTERc Manual

20-30 minute structured conversation following guidelines and instruction within the Mini-AFTERc 20 page manual

this consists of a 20-30 minute conversation about the general well-being of the patient with no specific reference to recurrence fears unless raised by the patient explicitly themselves

telephone call

Gerry Humphris, PhD

This is a controlled trial of the Mini-AFTERc intervention to reduce fears of recurrence in breast cancer patients. The sample will be collected in NHS Fife Breast Cancer Services (n=32). The intervention is a short telephone counseling service of 20 minutes delivered by the patient's breast cancer specialist nurse. Dependent measures consist of the ACCRE FoR 4 item measure and the EORTC Intervention overall satisfaction scale.

1. Background The majority of breast cancer patients completes successfully their treatment and therefore become survivors with some of them experience negative outcomes. One of the most prevalent unmet needs of the breast cancer survivors is Fear of Recurrence. Fear of Cancer Recurrence is defined as "the fear or worry that cancer will return, progress or metastasise". More specifically, 33% to 96% of the patients report FoR of cancer, while in 9% to 34% of these patients, the fear of recurrence is so detrimental even to their lives. Women of younger age with children have reported to have more severe FCR .

   Findings suggest that FoR can remain stable in cancer survivors five years or more after the diagnosis . Research has shown that cancer survivors that experience FoR, suffer from psychological and affective difficulties because of their initial worries of being cancer patients a second time. The most frequent of these negative outcomes are distress, stress-response symptoms and lower quality of life. Consequently, there is much interest of the researchers to focus on the factors that influence FoR in cancer patients, and the effect of FoR in survivors' quality of life . Less research has focused on interventions that can reduce fear of recurrence in cancer patients. The AFTER intervention is one of them, conducted a systematic intervention. The intervention was successful, since the study reported reduction in FoR at 6 month follow-up.

   The aim of the current study is to examine the effect of the Mini-AFTERc intervention, which is a shorter version of AFTER intervention, in reduction of fear of recurrence in breast cancer survivors with moderate level of FoR in comparison with a control group, where as the full AFTER intervention target patients with more severe FoR.
2. Research Question Whether the single-session intervention Mini AFTERc, delivered by a phone call, can reduce fear of recurrence in breast cancer patients with moderate level of fear in contrast with a control group.
3. Hypothesis The mini AFTERc intervention will reduce fear of recurrence in breast cancer patients with moderate level of fear, whereas FoR will not be reduced in the control group.
4. Methods and materials 4.1 Study design The study will be a quasi-experiment design implementing a single-session intervention which is aimed at reducing fear of recurrence in breast cancer patients with moderate level of fear, whereas FoR will not be reduced in the comparison group.

   4.2 Location of study The location of the study will be at NHS fife, Breast Cancer Unit of Queen Margaret Hospital, Dunfermline, where breast cancer patients can be treated and supported. Three experienced nurses of this unit will employ the Mini-AFTERc intervention.

   4.3 Participants Patients of NHS fife, Breast Cancer Unit of Queen Margaret Hospital, Dunfermline, in order to be included in the study, have to be breast cancer patients who have completed primary treatment and are worried about fear of cancer recurrence. An estimated number of participants are 34 patients to be able to answer successfully the research question. More specifically, the 17 patients of the treated group will receive a structured phone, based on the mini AFTERc intervention, whereas call the 17 patients of the control group will receive a standard phone call, which will not be a mini- After. A power analysis was conducted using NQueryAdvisor. A sample size of 17 in each group will have 80% power to detect a difference in means of 4 on the four item Fears of Recurrence Scale (the difference between the Control group mean: 25 and a Intervention group mean: 21) assuming that the common standard deviation is 4 using a two group t-test with a 0.05 two-sided significance level. Values obtained of SD and likely effect size from unpublished data held by Ozakinci and Humphris of breast and colorectal cancer patients and the original feasibility study conducted by Davidson and Humphris.

   All patients of the unit are welcome to participate. Participants will be invited in the study after the primary treatment, during a routine-care follow-up. The information sheet, the consent form and a pre-paid envelope will be provided in the patients. After they have completed the consent form, they will complete the questionnaire measure of FoR severity (ACCRE), in which they have to score above the cut-off to be included in the study.

   4.4 Measures and intervention The severity of FoR will be measured by employing the 4-item severity scale ACCRE at baseline and at 1-month follow-up. The second outcome measure will be the EORTC Satisfaction of Intervention measuring the overall satisfaction of the patients. The study will employ the Mini-AFTERc intervention, which is based on the six-session full AFTER intervention. The AFTER intervention was initially developed for head and neck patients to be targeted as patients with high level of FoR.

   The Mini-AFTERc intervention is a single-session, cognitive behavioral intervention based on the Leventhal's Self-Regulation Model and has been designed to be used with patients who report moderate levels of FoR. The aim of the intervention is to normalize and reduce FoR to a manageable level but still facilitate patients to be aware of the risks. The patients are enabled to be vigilant in symptoms change.
5. Data analysis The audio recording of the intervention consultation will be transcribed. Analysis of pre and post tests will be conducted by SPSS Predictive Analytics software v.21. The post-test will be subtracted from the pre-test to derive a change score. An analysis of variance will be conducted with a number of covariates (i.e. age and disease severity). The dependent variable will be the FoR ACCRE change score
6. Ethical approval

   The National Research Ethics Service will be contacted to prepare the NRES form and NHS Fife R\&D Governance forms as the study will be conducted with NHS Fife.

   Furthermore, we need to apply UTREC Ethics for the University of St Andrews, too.
7. Governance of study and support of participants The research project will be supervised by Professor Gerry Humphris. If needed, additional support to the patients will be provided by The Psychological Services at Edinburgh Cancer Unit, where Professor Humphris is a honorary clinical psychology consultant to the service and can pick up these referrals.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mini-AFTERc Intervention for Fear of Cancer Recurrence	NCT03763825	Breast Cancer Fear of Cancer	Mini-AFTERc	18 Years -	University of St Andrews
Personalized Alerts and Care Pathways to Prompt Prevention Interventions for Alcohol and Tobacco Users in Primary Care	NCT03108144	Cancer	Brief alcohol i...	-	Centre for Addiction and Mental Health
A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients	NCT02357927	Fear	Mini-AFTERc telephone call	18 Years - 80 Years	University of St Andrews
Personalized Alerts and Care Pathways to Prompt Prevention Interventions for Alcohol and Tobacco Users in Primary Care	NCT03108144	Cancer	Brief alcohol i...	-	Centre for Addiction and Mental Health
Mini-AFTERc Intervention for Fear of Cancer Recurrence	NCT03763825	Breast Cancer Fear of Cancer	Mini-AFTERc	18 Years -	University of St Andrews

Spots Global Cancer Trial Database for brief intervention