Lung CancerNCT04315207
Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis
A study testing Telephone call and In-person meeting in people with Lung Cancer and Diagnoses Disease, run by Naestved Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Diagnoses Disease, Psychosocial Stressor
- What is being tested?
- Telephone call and In-person meeting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2012to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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).
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Consequences of Receiving Results of Lung Cancer Workup by Telephone or In-person
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.
Read the 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:
- 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.
- Conditions
- Lung Cancer, Diagnoses Disease, Psychosocial Stressor
- Being tested
- Telephone call, In-person meeting
- Keywords
- Invasive workup, Breaking bad news, Endoscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone callBehavioural
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.
In-person meetingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Behavioral: Telephone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization
Secondary outcomes (1)
Patient-perceived change at follow-up
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
Measured: Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Oct 2012
- Primary completion19 Apr 2017
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1), controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Uffe Bodtger, PhD, Principal investigator, Dep. of Respiratory Medicine; Naestved HospitalJohn Brodersen, PhD, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315207
- Sponsor's protocol ID
- 12-000660
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Troubles concerning Danish data protection regulations in sharing outside Denmark
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Consequences of Receiving Results of Lung Cancer Workup by Telephone or In-person
- ClinicalTrials.gov ID
- NCT04315207
- Acronym / sponsor ID
- 12-000660
- Conditions
- Lung Cancer, Diagnoses Disease, Psychosocial Stressor
- Keywords
- Invasive workup, Breaking bad news, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (1:1), controlled trial
| Arm | Type | Receives |
|---|---|---|
| In-person visit | Active comparator | Behavioral: In-person meetingIn-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 | Experimental | Behavioral: Telephone callTelephone 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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).
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone callAll 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. | Behavioural | Telephone call |
| In-person meetingAll 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. | Behavioural | In-person visit |
Primary outcome
Change in psychosocial consequences
Time frame: Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization
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).
1 secondary outcome
Patient-perceived change at follow-up
Time frame: Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: Undecided. Troubles concerning Danish data protection regulations in sharing outside Denmark
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uffe Bodtger, PhD principal investigator
Dep. of Respiratory Medicine; Naestved Hospital
John Brodersen, PhD study chair
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone call and In-person meeting in people with Lung Cancer and Diagnoses Disease, run by Naestved Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychosocial consequences (time frame: Four weeks after receiving final diagnoses, equaling approximately 5 weeks randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.