Investigating the Impact of Tailored Reports on Anxiety
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- patients' views three months after intervention
研究概览
简要总结
Objective: To explore the hypothesis that different methods of selecting and printing information for cancer patients could improve emotional support by affecting interaction with others, and so lead to improved psychological wellbeing.
Design: Randomised trial with 8 groups (three factors, 2X2X2). Data collected at recruitment and three month follow-up.
Participants: 400 patients starting radiotherapy and their 'confidant' (the person in who they confide).
Interventions: Printed booklets.
- Half had 'general' CancerBACUP information for that cancer; half had 'personal' information from the medical record plus selected general information;
- Half chose information by 'interacting' with the computer; half had a larger volume of material in booklets that were produced 'automatically'.
- Half had additional 'anxiety management advice'.
Outcomes: Patients' views; use of booklet with others; change in reported social support; change in anxiety and depression.
详细描述
Aim:
- Based on a randomised trial the researchers aimed to model use of leaflets in the home as a function of three factors:
- whether patients chose the information themselves or if it was chosen for them;
- whether it included personal information from their own medical record or not;
- whether it included anxiety management advice or not.
- The researchers aimed to model patient and confidant's anxiety at three months as a function of these three factors and patients' use of leaflets in the home.
Patient Population: Beatson Oncology Centre (BOC). Patients thought to be eligible were to be identified from outpatient appointment diaries over fifteen months. Medical records were to be checked for all those initially identified to ensure that patients have breast, gynaecological, prostate or bladder or testicular, or selected cancers of the head or neck. Patients excluded were to be those:
- receiving palliative treatment,
- with no knowledge or understanding of their diagnosis (very few),
- with visual or mental handicap,
- with severe pain or symptoms causing distress,
- medical or nursing students,
- taking part in other trials with possibly confounding interventions, and
- those not giving informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Patients starting outpatient radiotherapy treatment with breast, prostate, cervical or laryngeal cancer
排除标准
- •Receiving palliative care
- •Severe pain or symptoms causing distress
- •Having cancer at other sites
- •Having no spoken English
- •Receiving treatment for psychological or psychiatric problems
- •Visual or mental handicap
- •Having case notes not available or ambiguous or illegible.
结局指标
主要结局
patients' views three months after intervention
use of booklet with others between intervention and three month follow up
change in reported social support between recruitment and three month follow up
change in anxiety and depression between recruitment and three month follow up
次要结局
- confidants' views three months after intervention
- change in confidants' anxiety and depression between recruitment and three month follow up