Cross-sectorial Rehabilitation of Patients with Lung Cancer

NCT06705465 | Recruiting

• 1 other identifier: CBalle
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Four thousand seven hundred patients are diagnosed with lung cancer in Denmark every year. Even though cigarette smoking has declined for decades a decline in lung cancer incidence is still at least a decade away. Only 16% of these patients with lung cancer started in a municipal rehabilitation program. Aim: To investigate if the intervention "early contact conference" can facilitate acceptance of and participation in municipal rehabilitation in patients with lung cancer. Further, to investigate whether the rehabilitation improve the patients' physical ability and quality of life. Thirteen municipalities from Region Hovedstaden have agreed to participate in this cluster randomized controlled trial. The intervention will focus on creating early contact between the Department of Oncology and the municipalities. The conference call will be planned when the patient is at the hospital for the second systemic treatment and a written status will be sent to the GP after the conference video call so that hospital, municipality, and GP will all have the newest knowledge about the patient's general condition The intervention will be easy to implement in clinical practice afterwards if it is a success and the cost of the intervention is low.

Conditions

Lung Cancer Non-Small Cell Cancer (NSCLC)

Keywords

rehabilitation; cross-sectorial collaboration; video conference

Outcome Measures

Primary Outcomes (1)

• Early contact conference

  • Will an "early contact conference" with the primary sector increase the number of patients with NSCLC starting rehabilitation in the municipality?

  6 months after treatment start

Secondary Outcomes (1)

• Quality of life

  EORTC-C30 baseline, 3 weeks, 9 weeks, 6 months

Study Arms (2)

Intervention group: video conference

EXPERIMENTAL

Behavioral: video conference

No intervention

NO INTERVENTION

Interventions

video conference BEHAVIORAL

video conference

Intervention group: video conference

Eligibility Criteria

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

You may qualify if:

• patients diagnosed with NSCLC
• \. line systemic treatment

You may not qualify if:

• cannot speak, understand, and/or read Danish
• cognitive/psychologically unfit to give consent

Sponsors & Collaborators

• Camilla Balle: lead

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, Denmark, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Camilla S Balle, PhD student

CONTACT

+45 51332047; camilla.sick.balle@regionh.dk

Julia S Johansen, Professor

CONTACT

+45 38689241; Julia.Sidenius.Johansen@regionh.dk

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: Principal investigator, phD student

Model Details: RCT

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)