Clinical trial NCT04315207: Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis
Official title: Psychosocial Consequences of Receiving Results of Lung Cancer Workup by Telephone or In-person
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Diagnoses Disease
Psychosocial Stressor
Keywords: Invasive workup
Breaking bad news
Endoscopy
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2020-03-19
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized (1:1), controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

(all are mandatory)

1. suspicions lesions in lung, chest wall or mediastinum at CT or PET-CT
2. a clinician's decision of invasive work-up for suspected or possible malignancy.
3. expected survival of more than 5 weeks (as judged by a local investigator).

Exclusion Criteria:

1. age younger than 18 years
2. need of in-patient care
3. disease manifestation needing urgent care (e.g. spinal cord compression, superior vena cava superior syndrome) and
4. inability to provide verbal and written informed consent -

Primary outcomes:
measure: Change in psychosocial consequences
timeFrame: Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization
Secondary outcomes:
measure: Patient-perceived change at follow-up
timeFrame: Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: Department of Respiratory Medicine
Study officials:
affiliation: Dep. of Respiratory Medicine; Naestved Hospital
name: Uffe Bodtger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: John Brodersen, PhD
role: STUDY_CHAIR
References: