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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608410
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : December 23, 2019
Sponsor:
Collaborators:
Danish Cancer Society
Danish Lung Cancer Group
Information provided by (Responsible Party):
Rasmus Blechingberg Friis, Regional Hospital West Jutland

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Other: Weekly Internet based PRO questionnaires Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The randomization will be done by the AmbuFlex-system (a generic on-line system for self-recorded patient reported outcomes) as a part of the inclusion process.

A text message reminder is sent weekly for patients in the intervention group by the system.

Quality of Life questionnaires will automatically be sent via a safe internet connection to participants in both groups every 2 months.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: ProWide - Patient Reported Outcomes Used for Weekly Internet-based DEtection of Progressive Disease in Lung Cancer; a Randomized Controlled Trial
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRO intervention
Weekly PRO questionnaires Quality of life every 2 months
Other: Weekly Internet based PRO questionnaires
If core symptoms worsen and exceeds a predefined threshold, a PRO-notification is sent to the hospital.

No Intervention: Standard of care
Quality of life every 2 months



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. ECOG (Eastern Cooperative Oncology Group) Performance status at time of progression [ Time Frame: 2 years ]

    (0-5) 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)

    1. - 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)
    2. - 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)
    3. - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)
    4. - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
    5. - Death

  2. Progression free survival [ Time Frame: 2 years ]
  3. Type of treatment at time of progression [ Time Frame: 2 years ]
    Number of patients who are candidates for 2nd line medical antineoplastic treatment

  4. Quality of life (QOL) measured by EuroQol EQ-5D-5L. [ Time Frame: 2 years ]
    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.

  5. Quality of life measured by EORTC QLQ C30/LC13. [ Time Frame: 2 years ]

    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.


  6. HADS score (Hospital Anxiety And Depression Scale) [ Time Frame: 2 years ]

    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.


  7. Qualitative interviews [ Time Frame: 2 years ]
    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.

  8. Baseline questionnaires of non-participants [ Time Frame: 2 years ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608410


Contacts
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Contact: Rasmus Friis, MD 004561303479 rasfri@rm.dk
Contact: Halla Skuladottir, MD Hallskul@rm.dk

Locations
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Denmark
Department of oncology, Regional Hospital West Jutland Recruiting
Herning, Denmark, 7400
Contact: Rasmus Friis, MD         
Sponsors and Collaborators
Regional Hospital West Jutland
Danish Cancer Society
Danish Lung Cancer Group
Investigators
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Principal Investigator: Rasmus Friis, MD Department of Oncology, Regional Hospital West Jutland
  Study Documents (Full-Text)

Documents provided by Rasmus Blechingberg Friis, Regional Hospital West Jutland:

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Responsible Party: Rasmus Blechingberg Friis, MD, Principal Investigator, Regional Hospital West Jutland
ClinicalTrials.gov Identifier: NCT03608410    
Other Study ID Numbers: ProWide
R184-A11805-17-S57 ( Other Grant/Funding Number: Danish Cancer Society )
2017-41-5251 ( Registry Identifier: Danish Data Protection Agency )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rasmus Blechingberg Friis, Regional Hospital West Jutland:
Patient reported outcomes
Internet
TelePRO
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases