NCT07235098

Brief Summary

This study aims at evaluating whether music therapy intervention is effective in decreasing psychological (distress) and physical symptoms (pain) in patients with suspected or diagnosed lung cancer undergoing minimally invasive lung surgery.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

lung cancerpainanxietymusic

Outcome Measures

Primary Outcomes (2)

  • Level of distress

    Change of the level of distress on the Distress thermometer

    From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)

  • Pain intensity

    Change of pain intensity on the numerical scale

    From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)

Secondary Outcomes (2)

  • Serum cortisol levels

    From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)

  • Additional doses of analgesics for pain control

    From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)

Study Arms (2)

Arm A treated with classical music therapy and standard of care

EXPERIMENTAL

Patients with suspected or diagnosed lung cancer undergoing minimally invasive lung resection will be treated with classical music therapy and standard of care.

Other: Music therapy intervention

Arm B treated with standard of care only

NO INTERVENTION

Patients with suspected or diagnosed lung cancer undergoing minimally invasive lung resection will be treated with standard of care only.

Interventions

Patient randomized to experimental Arm A will receive a classical music therapy intervention throughout the duration of their hospital stay for a minimally invasive lung resection.

Arm A treated with classical music therapy and standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected or confirmed diagnosis of lung cancer
  • Age ≥ 18 years
  • Indication for lung resection through a minimally invasive surgery
  • Signed written informed consent

You may not qualify if:

  • Endocrinological disorders involving cortisol axis
  • Chronic steroid intake \> 10 mg/day
  • Concomitant treatment with drugs against symptomatic anxiety and/or depression
  • Partial or complete hearing loss
  • Inability to follow the schedule of investigation
  • Patient unwilling to refrain from actively listening to other music (e.g., via other personal devices/headphones) outside of the prescribed musical intervention defined by the study protocol during the hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, Canton Ticino, 6500, Switzerland

Location

MeSH Terms

Conditions

Lung NeoplasmsPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Patrizia Froesch, MD

CONTACT

Luigi Tortola, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a monocentric open-label randomized controlled clinical trial with two arms: * Arm A: classical music therapy + standard of care (SOC) * Arm B: SOC only Patients scheduled for minimally invasive lung resection, with a suspected or confirmed diagnosis of lung cancer, will be enrolled and randomized to one of the two arms of the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations