Lung Cancer (Suspected or Confirmed)
Conditions
Keywords
lung cancer, pain, anxiety, music
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.
Detailed description
A diagnosis of cancer may result in extensive emotional, physical and social suffering. Moreover, surgical treatment of lung cancer represents itself a stressful event. It is important that cancer care incorporates services that help meet patients' psychological, social and spiritual needs. Music therapy interventions have been used to alleviate symptoms and treatment side effects in cancer patients and their efficacy has been demonstrated in various settings. Within the distinction between music therapy (a personalized approach based on the interaction with a trained music therapist) and music medicine (with pre-recorded music), the best efficacy results have been reported with music therapy. The use of music listening is growing in the field of music therapy intervention because of the impact musical contents can have on physiological, psychological and behavioural levels. The primary objective of this study is to evaluate 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. Secondary objectives are the evaluation of the decrease of the serum cortisol as biomarker of stress and the request of additional doses of analgesics for pain control.
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.
Sponsors
Oncology Institute of Southern Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspected or confirmed diagnosis of lung cancer * Age ≥ 18 years * Indication for lung resection through a minimally invasive surgery * Signed written informed consent
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of distress | From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery) | Change of the level of distress on the Distress thermometer |
| Pain intensity | From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery) | Change of pain intensity on the numerical scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum cortisol levels | From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery) | Change in the levels of serum cortisol measured in the morning |
| 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) | Number of additional doses of analgesics administered for pain control per day |
Countries
Switzerland
Contacts
CONTACTPatrizia Froesch, MD
CONTACTLuigi Tortola, PhD
Outcome results
None listed