Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer

NCT05621902 | Not Yet Recruiting DMC

• 1 other identifier: 102877
• Study Type: interventional
• Target: 398
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

Sweden

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival

  From date of randomization until the date of death from any cause, assessed up to 60 months.

Secondary Outcomes (6)

• Progression free survival

  From date of randomization until the date of first confirmed disease progression as judged by the investigator, assessed up to 24 months.

• Performance status

  At baseline and at each clinical visit (approximately every 3-4 months), assessed up to 24 months.

• Proportion of patients starting second-line anti-neoplastic treatment

  Assessed up to 24 months.

• Quality of life

  At baseline and every three months, assessed up to 24 months.

• Symptoms of depression

  At baseline and every three months, assessed up to 24 months.

Study Arms (2)

Weekly symptom monitoring

EXPERIMENTAL

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

Other: Weekly symptom monitoring

Standard care

NO INTERVENTION

Standard follow-up according to guidelines

Interventions

Weekly symptom monitoring OTHER

Patients randomized to the intervention arm will be invited to respond to a web-based weekly 11-item signs- and symptoms questionnaire

Weekly symptom monitoring

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mats Lambe: lead
• Uppsala University Hospital: collaborator
• Gävle Hospital: collaborator

Related Publications (5)

• 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.

  PMID: 30667494 BACKGROUND

• 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.

  PMID: 28029308 BACKGROUND

• 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.

  PMID: 28486004 BACKGROUND

• 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.

  PMID: 28423408 BACKGROUND

• 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.

  PMID: 28961852 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gunnar L Wagenius, MD,PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mats P Lambe, MD, PhD

CONTACT

+46707715655; mats.lambe@ki.se

Sandra Irenaeus, MD,PhD

CONTACT

+46727180099; sandra.irenaeus@rccmellan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 18, 2022
• Study Start: November 18, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share