## Protocol Section
### Identification Module
**NCT ID:** NCT01870479

**Brief Title:** Music & Cancer - Live Music During Chemotherapy

**Official Title:** Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment

#### Organization Study ID Info
**ID:** S-20120118
#### Organization
**Class:** OTHER
**Full Name:** University of Southern Denmark
### Status Module
#### Completion Date
**Date:** 2017-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-06-19

**Type:** ACTUAL

**Last Update Submit Date:** 2018-06-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Start Date
**Date:** 2013-05

**Type:** ACTUAL

**Status Verified Date:** 2018-06

#### Study First Post Date
**Date:** 2013-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2013-04-09
**Study First Submit QC Date:** 2013-06-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Danish Cancer Society

**Class:** OTHER

**Name:** University of Aarhus

#### Lead Sponsor

**Class:** OTHER

**Name:** Margrethe Langer Bro

#### Responsible Party

**Investigator Affiliation:** University of Southern Denmark

**Investigator Full Name:** Margrethe Langer Bro

**Investigator Title:** Assistant professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Non Hodgkin´s Lymphomas

- Hodgkin´s Lymphomas

**Keywords:**

- Malignant Lymphoma

- Chemotherapy

- Music therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 143

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient preferred live music during chemotherapy session.

**Intervention Names:**

- Other: Live music

**Label:** Live music

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patient preferred taped music during chemotherapy

**Intervention Names:**

- Other: Taped music

**Label:** Taped music

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Usual care during chemotherapy

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Live music

**Name:** Live music

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Taped music

**Name:** Taped music

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** STAI-S Spielberger State-Trait Anxiety Scale-State

**Measure:** Anxiety (STAI)

**Time Frame:** Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)

#### Secondary Outcomes

**Description:** Blood samples

**Measure:** Serum catecholamines

**Time Frame:** Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)

**Description:** Patient diary

**Measure:** Nausea

**Time Frame:** Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)

**Description:** Quality of Life Questionnaire: QLQ-C30

**Measure:** Quality of life

**Time Frame:** Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)

**Description:** Hospital Anxiety and Depression Scale (HADS)

**Measure:** Anxiety (HADS)

**Time Frame:** Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)

**Description:** questionaire: The Distress Thermometer

**Measure:** Distress

**Time Frame:** Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)

**Description:** STAI-S Spielberger State-Trait Anxiety Scale-State

**Measure:** Anxiety (STAI)

**Time Frame:** 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.

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aarhus

**Country:** Denmark

**Facility:** Aarhus University Hospital

**State:** Central Denmark Region

**Zip:** 8000

**Location 2:**

**City:** Esbjerg

**Country:** Denmark

**Facility:** Hospital of Southwest Jutland

**State:** Region Of Southwest Denmark

**Zip:** 6700

**Location 3:**

**City:** Odense

**Country:** Denmark

**Facility:** Odense University Hospital

**State:** Region Of Southwest Denmark

**Zip:** 5000

**Location 4:**

**City:** Odense

**Country:** Denmark

**Facility:** The Academy of Music and Dramatic Arts, Southern Denmark

**State:** Region Of Southwest Denmark

**Zip:** 5000

**Location 5:**

**City:** Roskilde

**Country:** Denmark

**Facility:** Roskilde Sygehus

**State:** Region Zealand

**Zip:** 4000

**Location 6:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Rigshospitalet

**State:** The Capital Region Of Denmark

**Zip:** 2100

**Location 7:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Herlev Hospital

**State:** The Capital Region Of Denmark

**Zip:** 2730

#### Overall Officials

**Official 1:**

**Affiliation:** IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark

**Name:** Margrethe L Bro, PhD student

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M9751

- Name: Hodgkin Disease

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T2817

- Name: Hodgkin Lymphoma

- Relevance: HIGH

- As Found: Hodgkin Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

### Misc Info Module

- Version Holder: 2024-05-24
