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

NCT04315207 | Completed

• 1 other identifier: 12-000660
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Diagnoses Disease; Psychosocial Stressor

Keywords

Invasive workup; Breaking bad news; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Change in psychosocial consequences

  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).

  Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization

Secondary Outcomes (1)

• Patient-perceived change at follow-up

  Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization

Study Arms (2)

In-person visit

ACTIVE COMPARATOR

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).

Behavioral: In-person meeting

Telephone call

EXPERIMENTAL

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

Behavioral: Telephone call

Interventions

Telephone call BEHAVIORAL

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.

Telephone call

In-person meeting BEHAVIORAL

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 visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Naestved Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Department of Respiratory Medicine

Næstved, DK-4700, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Uffe Bodtger, PhD

  Dep. of Respiratory Medicine; Naestved Hospital

  PRINCIPAL INVESTIGATOR

• John Brodersen, PhD

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary endpoint is a patient-reported outcome. Statistician were blinded to intervention until all statistical analyses were conducted
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized (1:1), controlled trial

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: October 1, 2012
• Primary Completion: April 19, 2017
• Study Completion: September 15, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

DK (1)