Effects of Creative Arts Therapy on Body Image, Self-esteem, Anxiety and Depression in Men With Prostate Cancer After Active Treatment: A Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Retention rate
研究概览
简要总结
The goal of this clinical study is to assess the feasibility of implementing a creative arts therapy intervention of drawing and painting in Hong Kong prostate cancer patients and preliminarily examine the effects of this intervention on prostate cancer patients' health outcomes via a two-armed randomized controlled trial. The two arms will be (i) the creative arts therapy intervention group and (ii) a active control group.
Participants will join five sessions. Sessions will start with a 10-15-minute rapport-building discussion and continue with a 60-minute intervention. Session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion. Each session will follow a three-step process of psychodynamic model to ensure the optimal effect of the intervention. The interventions will be held at private room at hospital.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult participants diagnosed with localised prostate cancer, regardless of the stage and age 18 years or older;
- •are not currently receiving active therapy, including chemotherapy, radiotherapy or surgical treatment, by the time of the study or completed treatment more than one year ago and are not on any active treatment;
- •were being followed up by the urology team or Department of Surgery at the Chinese University of Hong Kong;
- •are willing to participate in the study;
- •are able to read Chinese and communicate in Cantonese;
- •are physically able to attend and complete art therapy sessions;
- •do not have significant comorbidities, including cerebrovascular accident, severe depression, or dementia that could affect their ability to participate in the study;
- •signed an informed consent form.
排除标准
- •Adult participants diagnosed with a mixed type of terminal cancer;
- •are undergoing active therapy;
- •have participated in other art therapy interventions;
- •have physical issues preventing them from holding a pen;
- •have a mental status and/or communication problem that might compromise their capacity to give informed consent;
- •have significant comorbidities such as cerebrovascular accident, severe depression, or dementia, as determined by standardized screening tools a score of 20-27 on the Patient Health Questionnaire and score 25 or less on the Mini-Mental State Examination.
研究组 & 干预措施
Creative arts therapy
The intervention will be offered throughout five sessions. Session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion. The first individual session, 'bridge drawing', will be used to introduce the creative arts therapy approach and to elaborate on this project. The four other sessions will be group-based (with four participants per group), providing a supportive and communal environment where participants can engage in creative expression alongside others who may have had similar experiences or challenges. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre that has been equipped and prepared for the intervention.
干预措施: Creative arts therapy (Other)
Guided group discussions
Participants will engage in guided group discussions over five sessions. Each session will include a guided discussion focusing on self-care topics such as sleep hygiene, dental hygiene, nutrition, and personal interests and hobbies. The first individual session, 'Sleep hygiene, will be used to educate the participants of the importance of sleep and strategies to improve sleep quality. The four other sessions will be group-based (with four participants per group), focusing on dental hygiene, nutrition, personal interests and hobbies and general well-being and reflection. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre.
干预措施: Guided therapy group (Other)
结局指标
主要结局
Retention rate
时间窗: Baseline, 5 weeks and 3 months post
The number of patients who remain in the study divided by the number of patients randomised. The retention rate will be calculated for each arm at baseline and follow-ups.
Body image
时间窗: Baseline and 5 weeks
The Chinese version of the 10-item Body Image Scale (BIS) will be used to assess participants' perception of their body image, including influence, actions and cognition. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The BIS overall summary score ranges from 0 to 30, with a higher score indicating a poorer body image. The BIS was translated by school of nursing team at the Hong Kong Polytechnic University and has been utilised by our team
Self-esteem
时间窗: Baseline and 5 weeks
The Chinese version of the Rosenberg Self-Esteem Scale (RSES) will be used to evaluate participants' general self-esteem. It consists of 10 items assessing positive and negative feelings about the self. Each item is scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The RSES overall score ranges from 10 to 40, with a higher score indicating high self-esteem. The RSES version as translated by school of nursing team at the Hong Kong Polytechnic University and has been utilised by our team.
Anxiety and depression
时间窗: Baseline and 5 weeks
The Chinese version of the Hospital Anxiety and Depression Scale (HADS) will be used to assess participants' anxiety and depression levels. The HADS consists of 14 items categorised into two subscales: anxiety and depression. Scores for each subscale are calculated and classified into one of three categories: normal cases (scores of 0-7), borderline cases (scores of 8-10) and cases (scores of 11-21). The Chinese version of the HADS has a strong intercorrelation between anxiety and depression in cancer patients (r = 0.83).
次要结局
未报告次要终点
研究者
ABU ODAH, Hammoda MM
Research Assistant Professor
The Hong Kong Polytechnic University