The SEA-CHANGE Study: a Pilot Randomized Controlled Trial of the SElf-management After Cancer of the Head and Neck Group intErvention
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in the Functional Assessment of the Cancer Therapy scale (FACT-G and Head and Neck Cancer Subscale (FACT H&N)) from baseline up to 12 months
研究概览
简要总结
This study aims to test the feasibility of implementing the Self-Management after Cancer of the Head and Neck Group Intervention (SEA-CHANGE), designed to promote quality of life and participation in life activities and reduce distress in people who have completed primary treatment for head and neck cancer as compared to usual care.
详细描述
Head and neck cancer (HNC) and its treatment are associated with specific challenges such as facial disfigurement and impairments in speech, breathing and swallowing, and can have a negative impact on well-being. Self-management interventions can provide people with skills to deal with health-related problems, maintain life roles, and manage negative emotions, and have been found to increase confidence, improve quality of life, and reduce health service use across a range of chronic conditions.
The aim of this study is to pilot a self-management intervention (SEA-CHANGE) designed to promote quality of life and participation in life activities, and reduce distress in people who have completed primary treatment for HNC as compared to usual care. The study includes: (1) a pilot randomised study to assess the feasibility and acceptability of the intervention and its related procedures; (2) a qualitative process evaluation of the intervention; and (3) a systematic decision-making process regarding progression to a definitive trial. The expected outcome is a self-management intervention that is feasible and acceptable to HNC survivors and has the potential to realise both health benefits and economic gains.
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
- 否
入选标准
- •had a pathologically confirmed diagnosis of an invasive primary tumour in the head and neck (oral cavity, salivary glands, nasal cavity, sinuses, middle ear, pharynx and larynx);
- •have undergone and completed treatment by surgery, chemotherapy, radiotherapy or a combination thereof;
- •are aged 18 or older at the time of their HNC diagnosis;
- •are within 12 months of having completed their primary treatment; and
- •have provided written informed, consent.
排除标准
- •are unable to read or speak English;
- •had a second invasive primary cancer other than non-melanoma skin cancer diagnosed after the HNC (as these patients are likely to be more focused on the treatment of their second cancer rather than self-management of their HNC);
- •are unable to provide informed consent (e.g., if they have dementia/Alzheimer's disease); or
- •have other known medical condition or other reason why they would be unable to take part.
研究组 & 干预措施
Usual Care arm
Participants allocated to the control group will receive their usual care. Healthcare professionals within the designated sites will deliver aftercare treatment as usual, with no changes to the patient's clinical care. Participants in this arm do not receive the self-management intervention (SEA CHANGE).
Intervention arm
Participants in the intervention group will receive usual care and will be offered access to the self-management intervention (SEA CHANGE). Healthcare professionals within the designated sites will deliver aftercare treatment as usual, with no changes to the patient's clinical care.
干预措施: SEA CHANGE intervention (Behavioral)
结局指标
主要结局
Change in the Functional Assessment of the Cancer Therapy scale (FACT-G and Head and Neck Cancer Subscale (FACT H&N)) from baseline up to 12 months
时间窗: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
FACT-G consists of 4 domains and 27 statements, asking participants to consider the previous week and rate their Quality of life (QoL) across physical, social/family, emotional, and functional domains on a five point likert scale (0-4). FACT H\&N comprises 12 statements about HNC specific challenges and can be used independently of the FACT-G to indicate HNC specific QoL. Higher domain scores indicate higher QoL (Maximum domain scores: Physical 28; Social/Family 28; Emotional 24; Functional 28; FACT H\&N subscale 48). The FACT-G and FACT H\&N subscale have been widely used and validated and are commonly used to assess the QoL of HNC survivors.
次要结局
- Changes in The Distress Thermometer scale from baseline up to 12 months(12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months)
- Changes in the Social Role Participation Questionnaire (SRPQ) from baseline up to 12 months(12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months)
- Changes in the Fear of Recurrence/Relapse Scale from baseline up to 12 months(12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months)
- Changes in the UK Cancer Costs Questionnaire (UKCC) from baseline up to 12 months(12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months)
研究者
Pamela Gallagher, PhD
Prof Pamela Gallagher
Dublin City University