Feasibility of N-of-1 Trials to Evaluate Music Therapy in Patients With Breast Cancer Undergoing Adjuvant Chemotherapy: a Multicentre Pilot Study Protocol Integrated Music Therapy Program for Advanced Care in Breast Cancer Treatment (IMPACT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory
研究概览
简要总结
This study aims to evaluate the feasibility and potential benefits of music therapy in patients with breast cancer undergoing adjuvant chemotherapy.
Breast cancer patients often experience significant physical and psychological symptoms during treatment, including anxiety, fatigue and reduced quality of life. Music therapy is a promising non-pharmacological intervention that may help improve psychological well-being and symptom management. However, current evidence is mainly based on group-level studies and does not account for individual variability in response.
This pilot study is designed as a series of combined N-of-1 trials, in which each participant alternates periods with and without music therapy, acting as her own control. A total of 24 patients will be recruited from two Italian oncology centres and randomly assigned to different intervention sequences.
The intervention consists of weekly group music therapy sessions lasting approximately 60 minutes, including both active and receptive techniques, along with personalized music playlists for home use.
The primary objective is to assess the feasibility of this study design, including recruitment, retention, data completeness and acceptability of the intervention. Secondary objectives include exploring the effects of music therapy on psychological and physical well-being, as well as estimating variability in individual responses.
The results of this study will inform the design of future larger studies aimed at evaluating the effectiveness of music therapy using personalised trial approaches.
详细描述
Breast cancer is the most commonly diagnosed cancer among women worldwide and is frequently associated with a substantial burden of physical and psychological symptoms during treatment. Patients undergoing adjuvant chemotherapy often experience anxiety, fatigue, sleep disturbances and reduced quality of life, which may negatively affect treatment adherence and overall well-being. Addressing these multidimensional needs requires integrated, patient-centred supportive care approaches.
Music therapy (MT) is a clinical and evidence-based intervention delivered by trained therapists, using both active and receptive techniques to support psychological and emotional well-being. Previous studies have shown that MT may reduce anxiety and improve mood and quality of life in oncology settings. However, most available evidence is based on conventional group-level study designs, which do not adequately capture the variability in individual responses to the intervention.
N-of-1 trials represent an innovative methodological approach in which repeated treatment and control periods are compared within the same individual, allowing each patient to act as her own control. This design enables the evaluation of personalised treatment effects and intra-individual variability, which is particularly relevant for supportive care interventions such as music therapy.
This study is a multicentre, non-profit, interventional pilot study designed as a series of combined N-of-1 trials. A total of 24 patients with histologically confirmed breast cancer undergoing adjuvant chemotherapy will be recruited from two oncology centres in Italy. Participants will be randomly assigned to one of two intervention sequences, alternating periods with music therapy and periods without intervention according to a crossover design consisting of four consecutive phases (A-1, B-1, A-2, B-2), each lasting four weeks.
During intervention phases, participants will attend weekly group music therapy sessions lasting approximately 60 minutes. Sessions will include both receptive techniques (such as guided listening and music imagery) and active techniques (such as instrumental or vocal improvisation and songwriting). In addition, participants will receive personalised music playlists to be used between sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants will be eligible for inclusion if they meet all of the following criteria: - women age 25-75 years;
- •histologically confirmed diagnosis of BC;
- •undergoing adjuvant chemotherapy following surgery;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •ability to understand the Italian language and comply with study procedures;
- •provide written informed consent to study participation.
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •active neurological disorders;
- •active psychiatric disorders;
- •current or past substance abuse;
- •significant uncorrected visual, auditory or speech impairments;
- •have primary or metastatic brain tumours, as confirmed clinically or radiologically;
- •any condition that, in the opinion of the investigators, may interfere with participation in the study.
研究组 & 干预措施
Group 1-Musictherapy A
Music therapy in phase A1 and B1, no music therapy in phase A2 and B2
干预措施: Music Therapy (Other)
Group 2 -Musictherapy B
Music therapy in phase A2 and B2, no music therapy in phase A1 and B1
干预措施: Music Therapy (Other)
结局指标
主要结局
State-Trait Anxiety Inventory
时间窗: Every single session : 5 minutes before and 10 minutes after
Level of anxiety ( score 20-80)
次要结局
- Self-Rating Depression Scale (SDS),(Baseline (T0) - At the end of Cycle 1 (each cycle is 28 days) (T1) - At the end of Cycle 2 (each cycle is 28 days) (T2) - through study completion, up to 4 month (T3))
- Quality of Life (QoL)(Baseline (T0) - At the end of Cycle 1 (each cycle is 28 days) (T1) - At the end of Cycle 2 (each cycle is 28 days) (T2) - through study completion, up to 4 month (T3))
- Emotion Thermometers (ET)(every single session: 5 minutes before and 10 minutes after.)
- Visual Analogue Scale (VAS)(pre-post sessions)
- Pittsburgh Sleep Quality Index (PSQI).(Baseline (T0) - At the end of Cycle 1 (each cycle is 28 days) (T1) - At the end of Cycle 2 (each cycle is 28 days) (T2) - through study completion, up to 4 month (T3))