Music & Cancer - Live Music During Chemotherapy
Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment
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:
- Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment
- May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients.
- Is more effective in patients with good musical abilities.
- Is more effective than taped music.
Method: Intervention groups:
- Listening to patient-preferred live music during chemotherapy
- Listening to patient-preferred taped music during chemotherapy
- 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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Central Denmark Region
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Aarhus、Central Denmark Region、デンマーク、8000
- Aarhus University Hospital
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Region Of Southwest Denmark
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Esbjerg、Region Of Southwest Denmark、デンマーク、6700
- Hospital of Southwest Jutland
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Odense、Region Of Southwest Denmark、デンマーク、5000
- Odense University Hospital
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Odense、Region Of Southwest Denmark、デンマーク、5000
- The Academy of Music and Dramatic Arts, Southern Denmark
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Region Zealand
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Roskilde、Region Zealand、デンマーク、4000
- Roskilde Sygehus
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The Capital Region Of Denmark
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Copenhagen、The Capital Region Of Denmark、デンマーク、2100
- Rigshospitalet
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Copenhagen、The Capital Region Of Denmark、デンマーク、2730
- Herlev Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18+
- Newly diagnosed with malignant lymphoma and planned first line chemotherapy treatment
- Able to give informed consent
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Live music
Patient preferred live music during chemotherapy session.
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アクティブコンパレータ:Taped music
Patient preferred taped music during chemotherapy
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介入なし:Control
Usual care during chemotherapy
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Anxiety (STAI)
時間枠:Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
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STAI-S Spielberger State-Trait Anxiety Scale-State
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Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Serum catecholamines
時間枠:Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Blood samples
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Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Nausea
時間枠:Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
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Patient diary
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Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
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Quality of life
時間枠:Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Quality of Life Questionnaire: QLQ-C30
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Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Anxiety (HADS)
時間枠:Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
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Hospital Anxiety and Depression Scale (HADS)
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Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
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Distress
時間枠:Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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questionaire: The Distress Thermometer
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Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Anxiety (STAI)
時間枠: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.
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STAI-S Spielberger State-Trait Anxiety Scale-State
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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.
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Margrethe L Bro, PhD student、IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Live musicの臨床試験
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University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore Foundation完了
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Fondation Oeuvre de la Croix Saint-Simon引きこもった
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University Medical Center GroningenGGZ Drenthe Mental Health Institution募集
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University of Maryland, BaltimoreMedical Technology Enterprise Consortium (MTEC)完了
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U.S. Army Medical Research and Development CommandState University of New York - Upstate Medical University完了
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State University of New York - Upstate Medical...Walter Reed Army Institute of Research (WRAIR); U.S. Army Medical Research and Development Command完了
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State University of New York - Upstate Medical...U.S. Army Medical Research and Development Command; Janssen Pharmaceutica N.V., Belgium完了
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State University of New York - Upstate Medical...Walter Reed Army Institute of Research (WRAIR); U.S. Army Medical Research and Development Command積極的、募集していない