Intensified Follow-up of Lung Cancer Using Weekly Questionnaires Via the Internet

Lung Cancer Clinical Trial

— ProWide  

Official title:

ProWide - Patient Reported Outcomes Used for Weekly Internet-based DEtection of Progressive Disease in Lung Cancer; a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608410
• Other study ID #: ProWide
• Secondary ID: R184-A11805-17-S
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2023
• Source: Regional Hospital West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial (RCT) will test if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase survival in Danish lung cancer patients during follow-up or maintenance treatment. A threshold mechanism will automatically send an alert to the hospital in case of alarming or worsening symptoms and the patient will be contacted by the treating clinicians.

Description:

This multicenter RCT study enrolls patients diagnosed with stage IV og incurable stage III lung cancer who has non-progressive disease at first evaluation scan. Patients in follow-up or maintenance therapy are eligible.

492 patients will be included in the study with 246 patients in each group.

Intervention In the experimental arm, patients will be asked to fill in a web-based Patient Reported Outcome (PRO) questionnaire every week. If one of the reported symptoms worsens and exceed a predefined threshold of severity, a notification is automatically sent to the hospital. A nurse will review til questionnaire and contact the patient for verification of symptoms. If progression of disease is suspected, a CT scan will be made. Otherwise, the nurse will schedule a visit at the clinic for physical examination and evaluation by a clinician. If progressive disease is not suspected, supportive care will be adjusted and the patient will continue follow up according to the usual schedule.

The interventions ends in case of progressive disease.

Evaluation Baseline CT-scan of thorax and upper abdomen is performed prior to initial treatment and an evaluation CT scan at the time of enrolment. CT scans will be repeated for assessing signs of progression due to standard follow-up procedures in both groups. If progressive disease is suspected based on symptom development, the following scan will be rescheduled to as soon as possible.

Quality of life (QoL) will be measured in both groups using EORTC (European Organisation for Research and Treatment of Cancer) QOL-C30 / LC13 and HADS (Hospital Anxiety And Depression Scale) quality of life questionnaires every 2 month during the study period.

Objectives The primary objective is to test if supplementary weekly PRO monitoring increases overall survival in a Danish Lung Cancer population

Monitoring Clinical decisions taken on the basis of PRO notifications will daily be registered in the software system by the clinicians. Patient responses to questionnaires and PRO-notification handling by the clinical staff will be monitored by Primary Investigator.

End points will be entered by local site investigators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: November 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with lung cancer (NSCLC and SCLC), who have received 1st line induction treatment* for lung cancer and have no sign of progressive disease at first evaluation CT scan.

2. Patients diagnosed with stage III treated with palliative intention, and stage IV, regardless of treatment intention.

3. Diagnosis proven by cytology or histology

4. Age = 18 years

5. Performance status (PS) = 2 within 15 days before enrolment

6. First evaluation CT scan performed within four weeks from enrolment

7. Patient with acess to internet, Mobile phone and E-boks (Danish digital secure mail system)

8. Patient has given his/her written informed consent before any specific procedure from protocol

• Induction treatment includes:

• Standard doublet chemotherapy

• Immunotherapy

• Targeted therapy

• Palliative radiotherapy

• Local treatment of oligometastatic disease, including surgery and stereotactic radiotherapy

• Any combination of the above-mentioned treatment modalities Patients are eligible regardless of whether they at the time of inclusion continue maintenance treatment or not

Exclusion Criteria:

1. Progressive disease at first evaluation scan

2. Persons deprived of liberty or under guardianship or curators

3. Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial

4. Pregnant or breastfeeding women

5. Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol committee.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Weekly Internet based PRO questionnaires
If core symptoms worsen and exceeds a predefined threshold, a PRO-notification is sent to the hospital.

Locations

Country	Name	City	State
Denmark	Department of oncology, Regional Hospital West Jutland	Herning

Sponsors (3)

Lead Sponsor	Collaborator
Regional Hospital West Jutland	Danish Cancer Society, Danish Lung Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2 years
Secondary	ECOG (Eastern Cooperative Oncology Group) Performance status at time of progression	(0-5) 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction); - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work); - Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours); - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours); - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); - Death	2 years
Secondary	Progression free survival		2 years
Secondary	Type of treatment at time of progression	Number of patients who are candidates for 2nd line medical antineoplastic treatment	2 years
Secondary	Quality of life (QOL) measured by EuroQol EQ-5D-5L.	EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention.	2 years
Secondary	Quality of life measured by EORTC QLQ C30/LC13.	The EORTC QLQ-C30 questionnaire consists of 30 questions with five functional scores (physical, role, cognitive, emotional and social); a global health status score three symptom scale score (fatigue, pain, nausea and vomiting); and six independent one-item scores describing additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation and diarrhea) and financial burden.; The EORTC QLQ-LC13 is a supplementary module to the C30 questionnaire and generates a multiple-item scale score of dyspnea and a number of single-item scores that assesses chest pain, arm / shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia and hemoptysis.; All scales and single-item scores can be linearly transformed to a score ranged from 0 to 100. A higher score of global health and functional subscriptions indicates better functioning.	2 years
Secondary	HADS score (Hospital Anxiety And Depression Scale)	The HADS (The hospital anxiety and depression scale) is a fourteen-item scale. Seven items relate to depression and seven to anxiety. The tool has been developed for detection of anxiety and depression in patients with physical health problems. All items are scored from 0-3 with a possible total score between 0 and 21 for anxiety and depression respectably.; A cut-off point of >7 for anxiety or depression is considered significant.	2 years
Secondary	Qualitative interviews	Qualitative interviews with members of the clinical staff and a group of patients in the intervention arm will be conducted during the study period. The purpose is to identify barriers, advantages and possible reasons for the outcomes of the study.	2 years
Secondary	Baseline questionnaires of non-participants	All patients who met the inclusion criteria but declined to participate in the trial will be asked to fill in a questionnaire. The questionnaire will include information on socioeconomics, reasons for non-participation and the same HRQoL questionnaires that are filled in by the participants in the trial (EORTC QLQ-C30/LC13, HADS, EQ-5D-5L).; The purpose is to identify baseline differences between participants and non-participants and thereby testing the PRO system for generalizability.	2 years