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Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer (LUCA-S)

Primary Purpose

Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weekly symptom monitoring
Sponsored by
Mats Lambe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Sweden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytology proven non-small cell lung cancer (NSCLC) NSCLC stage III or IV ≥ 18 years ECOG performance status 0- 2 Eligible patients should have initiated first-line treatment for advanced or metastatic disease with chemotherapy and/or immunotherapy, radiochemotherapy or targeted treatment Patients are eligible for inclusion if they have responded to first-line treatment with stable disease, or better, at the first radiological evaluation performed up to six months after start of treatment Stable disease, or better, on radiological assessment within 28 days of enrolment (CT scan or FDG-PET/CT. Cerebral MRI if known brain metastasis) Initial web-based application score of ≤ 6 Basic computer literacy Bank-ID (electronic identification system) and access to "1177 Vårdguiden" The subject has given written consent to participate in the study Exclusion Criteria: Symptomatic brain metastases Pregnancy, breastfeeding, or planned pregnancy Persons under guardianship or deprived of liberty Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation Treatment or disease which, according to the investigator, can affect treatment or study results Ongoing participation in another interventional clinical study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Weekly symptom monitoring

    Standard care

    Arm Description

    Web-based weekly symptom monitoring in addition to standard follow-up

    Standard follow-up according to guidelines

    Outcomes

    Primary Outcome Measures

    Overall survival
    Overall survival

    Secondary Outcome Measures

    Progression free survival
    First confirmed disease progression
    Performance status
    Performance status will be evaluated according to the ECOG Perfomance Status Scale (Scale 0-5: 0 = fully active, able to carry on all pre-disease performance without restriction, 5=dead).
    Proportion of patients starting second-line anti-neoplastic treatment
    Proportion of patients starting second-line anti-neoplastic treatment within 12 weeks from date of confirmed disease progression after randomization.
    Quality of life
    Assessed by EORTC QLQ-C30-LC13 questionnaire. The QLQ-C30 is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
    Symptoms of depression
    Assessed by the Patient Health Questionnaire (PHQ9). Score 0 (no symptoms) to 27 (severe symptoms).
    Number of days of in-hospital care
    Health care consumption will be assessed as number of days of in-hospital care during study participation.

    Full Information

    First Posted
    November 4, 2022
    Last Updated
    November 11, 2022
    Sponsor
    Mats Lambe
    Collaborators
    Uppsala University Hospital, Gävle Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05621902
    Brief Title
    Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer
    Acronym
    LUCA-S
    Official Title
    Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 18, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mats Lambe
    Collaborators
    Uppsala University Hospital, Gävle Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to investigate if weekly symptom monitoring of patients with advanced lung cancer is associated with better survival and improved quality of life compared to standard follow-up. Each week, participants in the intervention group will be asked to respond to an electronic weekly questionnaire covering 11 items related to current health status.
    Detailed Description
    This is a prospective, multicentre, randomized, two-armed, open-label trial in which participants will be randomised to standard follow-up according to current management guidelines for lung cancer (control arm) or with the addition of weekly web-based symptom monitoring (intervention arm). Both study groups will be asked to fill out quality of life questionnaires before randomisation and every three months. In addition to comparing survival and quality of life, the study will also assess progression free survival, performance status, eligibility for second line anti-neoplastic treatment and health care consumption. All subjects will be followed for 24 months. Updated data on survival will also be collected up to 5-years. By innovative use of an IT platform already in use in Swedish cancer care, this trial will evaluate potential benefits of systematic symptom monitoring in patients with advanced lung cancer. If corroborating earlier reports of marked survival benefits, the results of this trial could change clinical practice and current guidelines for follow-up of lung cancer patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    Sweden

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    398 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Weekly symptom monitoring
    Arm Type
    Experimental
    Arm Description
    Web-based weekly symptom monitoring in addition to standard follow-up
    Arm Title
    Standard care
    Arm Type
    No Intervention
    Arm Description
    Standard follow-up according to guidelines
    Intervention Type
    Other
    Intervention Name(s)
    Weekly symptom monitoring
    Intervention Description
    Patients randomized to the intervention arm will be invited to respond to a web-based weekly 11-item signs- and symptoms questionnaire
    Primary Outcome Measure Information:
    Title
    Overall survival
    Description
    Overall survival
    Time Frame
    From date of randomization until the date of death from any cause, assessed up to 60 months.
    Secondary Outcome Measure Information:
    Title
    Progression free survival
    Description
    First confirmed disease progression
    Time Frame
    From date of randomization until the date of first confirmed disease progression as judged by the investigator, assessed up to 24 months.
    Title
    Performance status
    Description
    Performance status will be evaluated according to the ECOG Perfomance Status Scale (Scale 0-5: 0 = fully active, able to carry on all pre-disease performance without restriction, 5=dead).
    Time Frame
    At baseline and at each clinical visit (approximately every 3-4 months), assessed up to 24 months.
    Title
    Proportion of patients starting second-line anti-neoplastic treatment
    Description
    Proportion of patients starting second-line anti-neoplastic treatment within 12 weeks from date of confirmed disease progression after randomization.
    Time Frame
    Assessed up to 24 months.
    Title
    Quality of life
    Description
    Assessed by EORTC QLQ-C30-LC13 questionnaire. The QLQ-C30 is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
    Time Frame
    At baseline and every three months, assessed up to 24 months.
    Title
    Symptoms of depression
    Description
    Assessed by the Patient Health Questionnaire (PHQ9). Score 0 (no symptoms) to 27 (severe symptoms).
    Time Frame
    At baseline and every three months, assessed up to 24 months.
    Title
    Number of days of in-hospital care
    Description
    Health care consumption will be assessed as number of days of in-hospital care during study participation.
    Time Frame
    Assessed up to 24 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically or cytology proven non-small cell lung cancer (NSCLC) NSCLC stage III or IV ≥ 18 years ECOG performance status 0- 2 Eligible patients should have initiated first-line treatment for advanced or metastatic disease with chemotherapy and/or immunotherapy, radiochemotherapy or targeted treatment Patients are eligible for inclusion if they have responded to first-line treatment with stable disease, or better, at the first radiological evaluation performed up to six months after start of treatment Stable disease, or better, on radiological assessment within 28 days of enrolment (CT scan or FDG-PET/CT. Cerebral MRI if known brain metastasis) Initial web-based application score of ≤ 6 Basic computer literacy Bank-ID (electronic identification system) and access to "1177 Vårdguiden" The subject has given written consent to participate in the study Exclusion Criteria: Symptomatic brain metastases Pregnancy, breastfeeding, or planned pregnancy Persons under guardianship or deprived of liberty Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation Treatment or disease which, according to the investigator, can affect treatment or study results Ongoing participation in another interventional clinical study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mats P Lambe, MD, PhD
    Phone
    +46707715655
    Email
    mats.lambe@ki.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandra Irenaeus, MD,PhD
    Phone
    +46727180099
    Email
    sandra.irenaeus@rccmellan.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gunnar L Wagenius, MD,PhD
    Organizational Affiliation
    Karolinska University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30667494
    Citation
    Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085.
    Results Reference
    background
    PubMed Identifier
    28029308
    Citation
    Temel JS, Greer JA, El-Jawahri A, Pirl WF, Park ER, Jackson VA, Back AL, Kamdar M, Jacobsen J, Chittenden EH, Rinaldi SP, Gallagher ER, Eusebio JR, Li Z, Muzikansky A, Ryan DP. Effects of Early Integrated Palliative Care in Patients With Lung and GI Cancer: A Randomized Clinical Trial. J Clin Oncol. 2017 Mar 10;35(8):834-841. doi: 10.1200/JCO.2016.70.5046. Epub 2016 Dec 28.
    Results Reference
    background
    PubMed Identifier
    28486004
    Citation
    Nilsson J, Berglund A, Bergstrom S, Bergqvist M, Lambe M. The role of comorbidity in the management and prognosis in nonsmall cell lung cancer: a population-based study. Acta Oncol. 2017 Jul;56(7):949-956. doi: 10.1080/0284186X.2017.1324213. Epub 2017 May 9.
    Results Reference
    background
    PubMed Identifier
    28423408
    Citation
    Nipp R, Temel J. The Patient Knows Best: Incorporating Patient-Reported Outcomes Into Routine Clinical Care. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx044. No abstract available.
    Results Reference
    background
    PubMed Identifier
    28961852
    Citation
    Basch E, Snyder C. Overcoming barriers to integrating patient-reported outcomes in clinical practice and electronic health records. Ann Oncol. 2017 Oct 1;28(10):2332-2333. doi: 10.1093/annonc/mdx506. No abstract available.
    Results Reference
    background

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