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临床试验/NCT01870479
NCT01870479已完成不适用

Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment

Margrethe Langer Bro14 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2013年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
143
试验地点
14
主要终点
Anxiety (STAI)

研究概览

简要总结

Main purpose: To determine if live music moderates the level of chemotherapy related anxiety, in patients with haematological cancer

The investigators hypothesize that live music:

  1. Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment
  2. May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients.
  3. Is more effective in patients with good musical abilities.
  4. Is more effective than taped music.

Method: Intervention groups:

  1. Listening to patient-preferred live music during chemotherapy
  2. Listening to patient-preferred taped music during chemotherapy
  3. Standard care

Endpoints:

Primary: Level of anxiety measured by STAI. Secondary: Serum catecholamines.

Background: In order to establish the intervention procedures, the investigators have carried out a pilot study at the hematology department at Hospital of Southwest Denmark, including students from the Academy of Music and Dramatic Arts, Southern Denmark. The pilot results indicates that live music has an uplifting, pain relieving, and then releasing effect and that music has a positive impact on hospitalisation. According to the evaluation forms filled out by 243 cancer patients, the music experience has provided human anchorage/cohesion as a counterweight to disease fixation and alienation Chemotherapy involves major physical and psychological problems. Not much has been provided in the clinical setting which relieves the symptoms of anxiety associated with chemotherapy. A review of the literature illustrate the need for developing new potential areas of intervention that takes into account, that not only do cancer patients face challenges in everyday life ranging from physiological changes over social to psychological problems, but also during treatment procedures, which may cause a higher level of anxiety associated with these procedures, e.g., chemotherapy infusion.This project investigates to what degree live music may relieve some of these symptoms during treatment for haematological cancer. The project is created in order to both measure psychosocial effects as well as direct stress measures, i.e. serum catecholamine. These physiological changes are measured in order to shed light on the mechanism behind the potential effects of live music on discomfort in connection with chemotherapy treatment.

Perspectives: The vision of the project focus on strengthening the cancer patients' ability to cope with physiological and psychological issues during chemotherapy sessions and to make the patients conscious of music as an option in these coping efforts. Hopefully, the results will provide a scientific basis for an evaluation of the perspectives and the potentials of live music treatment during chemotherapy infusion among cancer patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed with malignant lymphoma and planned first line chemotherapy treatment
  • Able to give informed consent

排除标准

  • Patients who do not speak or understand Danish
  • Patients who are deaf or blind.
  • Any comorbidity that postpone planed chemotherapy for more than 4 weeks
  • Patients with alcohol or drugs misuse problems as stated in the medical record.
  • Patients with untreated mental illness as identified in the medical record

研究组 & 干预措施

Live music

Experimental

Patient preferred live music during chemotherapy session.

干预措施: Live music (Other)

Taped music

Active Comparator

Patient preferred taped music during chemotherapy

干预措施: Taped music (Other)

Control

No Intervention

Usual care during chemotherapy

结局指标

主要结局

Anxiety (STAI)

时间窗: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)

STAI-S Spielberger State-Trait Anxiety Scale-State

次要结局

  • Anxiety (HADS)(Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion))
  • Anxiety (STAI)(Measurement of STAI at baseline and after each chemotherapy 1 to 5 (on average 2, 4, 6 and 8 weeks after inclusion) as well as differences from baseline.)
  • Serum catecholamines(Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion))
  • Nausea(Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion))
  • Quality of life(Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion))
  • Distress(Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion))

研究者

发起方
Margrethe Langer Bro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Margrethe Langer Bro

Assistant professor

University of Southern Denmark

研究点 (14)

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