WhatsApp message

Telephone call will be made to invite subjects to participate in CRC screening

Telephone call

Yuen Tung Thomas Lam, MSc

It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries1. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 20142.

Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk asymptomatic individuals starting at age 503-5. Modalities such as guaiac-based fecal occult blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy (FS), and colonoscopy are among the acceptable options for CRC screening3-5.

Department of Health of Hong Kong launched a Colorectal Cancer Screening Pilot Program in late 2016. This is a subsidized program offering primary care consultation with FIT. For those subjects with FIT positive, colonoscopy specialist consultation and colonoscopy will be arranged.

The local uptake rate of CRC screening was reported to be 24.5%8 , which is relatively low when compared to other developed county9.

In recent years, social media (SM) has become an increasingly popular source of health information10. By providing an easily accessible and interactive channel of communication between reviewers and information providers, it has potential values for affecting public health. However, the effects of SM on uptake of CRC screening has not yet been studied.

WhatsApp Messenger, is the most popular social media messaging app worldwide. This randomized controlled study will investigate the effect of WhatsApp vs telephone intervention on the uptake of CRC screening.

Background It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries1. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 20142.

Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk asymptomatic individuals starting at age 503-5. Modalities such as guaiac-based fecal occult blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy (FS), and colonoscopy are among the acceptable options for CRC screening3-5.

Department of Health of Hong Kong launched a Colorectal Cancer Screening Pilot Program in late 2016. This is a subsidized program offering primary care consultation with FIT. For those subjects with FIT positive, colonoscopy specialist consultation and colonoscopy will be arranged.

The local uptake rate of CRC screening was reported to be 24.5%8 , which is relatively low when compared to other developed county9.

In recent years, social media (SM) has become an increasingly popular source of health information10. By providing an easily accessible and interactive channel of communication between reviewers and information providers, it has potential values for affecting public health. However, the effects of SM on uptake of CRC screening has not yet been studied.

WhatsApp Messenger, is the most popular social media messaging app worldwide. This randomized controlled study will investigate the effect of WhatsApp vs telephone intervention on the uptake of CRC screening.

Hypothesis Delivery of information of CRC screening program via SM can encourage uptake of CRC screening.

Aim To investigate the effectiveness of Delivery of information of CRC screening program via WhatsApp on the uptake of CRC screening

Effect of WhatsApp Messenger on Uptake of CRC Screening Study

The Effectiveness of WhatsApp Messenger on the Uptake of Colorectal Cancer Screening: a Non-inferiority Randomized Controlled Study

Number of subjects participating in CRC screening after study intervention divided by the total number of subjects in each study arm

Chinese University of Hong Kong

Nursing Officer

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Disease Attributes

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

Mini-AFTERc

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.

A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients

A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients (The Mini AFTERc): A Controlled Trial

University of St Andrews

Chair of Health Psychology

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

In-person meeting with the patient in the out-patient department. The patient is free to bring up to four\* relatives or other persons of their own choice to the in-person meeting.

(\* Restriction due to space limitation).

Telephone call with the patient. The patient is free to turn on loudspeaker to include relatives or other persons in the telephone conversation, alternatively to ask the physician to call and inform one relative or other person after the patient-doctor telephone call

All patients are informed that they will receive a telephone call between 08 AM and 5 PM on workdays, as soon as the results of invasive workup are available. This is expectedly 3 to 5 days after invasive workup. At the telephone call, patients are free to ask for a later call, to summon relatives, to turn on the loud speaker, and/or ask the physician to call one relative of choice to share the information.

Regardless of group, all patients are informed on the possibility of malignancy at every patient-physician encounter.

All patients are provided a written and verbal appointment date 5 workdays after invasive workup, and that they will receive a telephone call if 1) results are not available at the time of the meeting, and/or 2) if results need urgent action (such as small-cell lung cancer).

At the in-person meeting, patients are free to invite family and relatives (up to 4 persons, restriction due to space available).

Regardless of group, all patients are informed on the possibility of malignancy at every patient-physician encounter.

In-person meeting

Uffe Bodtger, PhD

John Brodersen, PhD

Disclosure of bad news is challenging for patients, relatives and healthcare providers. Current protocols for breaking bad news assume a single, in-person meeting for breaking bad news, however cancer workup is not a single event but a consecutive process with several contacts between patient and physician. Furthermore, an increasing number of patients receive their cancer diagnosis by telephone.

The investigators want to examine whether having the result of lung cancer workup by telephone results in worse psychosocial consequences than having the result in-person. Both groups receive information on possibility of cancer at every patient-physician contact.

Lung cancer is the most common cause of cancer death worldwide. Patient-friendly delivery of results of lung cancer workup is mandatory in an era of personalized medicine. The possibility of delivering health care using telephone has been acknowledged for various medical interactions such as genetic counselling, delivery of screening results, smoking cessation programmes, palliative interventions, and disclosing result of breast cancer workup. However, Retrospective observational studies have identified higher patients' satisfaction scores when the cancer diagnosis is conveyed by a physician with high communicative skills, in personal rather than in impersonal settings, in-person rather than by telephone, when the patients had a perception of opportunity to ask questions, and when conversations lasted more than10 minutes and included discussion of treatment options.

All current models for breaking bad news (SPIKES, Kayes' 10 step-model, PACIENTE, BREAK) all focus on a single patient-physician encounter, which is in contrast to the organization of contemporary cancer workup as a flow of examinations and thus multiple encounters.

The study aims to examine the effects on psychosocial consequences of receiving the final diagnosis of workup of suspected cancer in lung, pleura or mediastinum by telephone versus in-person when patients receive information on possible malignancy at every patient-physician encounter.

HYPOTHESES:

The main hypothesis of this study is that having the final diagnosis of cancer workup delivered by telephone (intervention group) is associated with worse psychosocial consequences than when delivered in-person (control group). More specifically, the hypothesis is:

1) Receiving the result of cancer workup results in decreased scores of the disease-specific questionnaire Consequences of Screening: Lung Cancer (COS-LC) compared to patients receiving their results in-person.

Potential moderators and mediators:

During the study potential mediating and moderating factors will be explored, e.g. including socio-demography, comorbidity, and disease-specific factors, will be investigated. Most importantly, results on patients with confirmed cancer are explored separately as will data on patients without a final diagnosis of malignancy.

METHODS:

Study design:

The study is a non-pharmacological two-armed randomized controlled trial with intervention group receiving the result of cancer workup by telephone (telephone group) and active control group receiving result of cancer workup in-person ("gold standard"; in-person group). Both groups will otherwise receive the same information and in the same way, thus regardless of group, all patients are informed on the possibility of malignancy at every patient-physician encounter.

Primary endpoint is a patient-reported outcome. Statistician were blinded to intervention until all statistical analyses were conducted

Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis

Psychosocial Consequences of Receiving Results of Lung Cancer Workup by Telephone or In-person

Troubles concerning Danish data protection regulations in sharing outside Denmark

Questionnaire COS-LC (Consequences of Screening - Lung Cancer) part 1. COS-LC part 1 consists of nine psychosocial scales (four core and five lung-cancer-screening-specific scales). Each scale is constructed from an individual number of items (see below), and each item has four response categories ordered on a continuum: "not at all", "a bit", "quite a bit" and "a lot": The minimum score of each item is 0 with a maximum of 3. The higher the scale score, the more negative the psychosocial consequences The four core scales measure "Anxiety" (7 items; scale score 0-21), "Behaviour" (7 items; scale score 0-21), "Dejection" (6 items; scale score 0-18), and "Sleep" (4 items; scale score 0-12).

The five lung-cancer-screening-specific scales measure "Self-blame" (5 items; scale score 0-15), "Focus on Airway Symptoms" (2 items; scale score 0-6), "Stigmatisation" (4 items; scale score 0-12), "Introvert" (4 items; scale score 0-12), and "Harm of Smoking" (2 items; scale score 0-6).

COS-LC part 2 encompasses six scales (24 items) focusing on patient-perceived changes at the time of follow-up (4 weeks after the final screening result) compared to baseline: "Calm/Relaxed" (2 items), "Social Relations" (3 items), "Existential Values" (6 items), "Impulsivity" (6 items), "Empathy" (3 items), and "Regretful of still Smoking" (4 items). All items in COS-LC part 2 have five response categories scored laterally reversed: "much less" 2, "less" 1, "the same as before" 0, "more" 1, and "much more" 2: Part 2 was designed and validated to measure changes, both positive and negative, and high scores denote more change

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of WhatsApp Messenger on Uptake of CRC Screening Study	NCT03337776	CRC	WhatsApp messag... Telephone call	50 Years - 75 Years	Chinese University of Hong Kong
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
Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis	NCT04315207	Lung Cancer Diagnoses Disea... Psychosocial St...	Telephone call In-person meeti...	18 Years -	Naestved Hospital

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