A Brief Hope Intervention to Increase the Hope Level and to Improve the Physical and Mental Health of Patients Receiving Palliative Care: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- State Hope Scale (SHS)
研究概览
简要总结
Aims. This paper describes the study protocol of a manualized brief positive intervention (BHI). In addition, it reports the on the modification of a hope intervention based on the theoretical proposition - hope theory, and its feasibility when applying to palliative cancer and non-cancer patients.
Background. Hope was found to account for therapeutic changes in clients with depressive symptoms or chronic pain. Nevertheless, little is known about the integration of such active ingredients to brief and low intensity psycho-therapeutic interventions to patients receiving palliative care were not adequately tested.
Design. The study included two stages: (1) manual development, and (2) a single blinded randomized controlled trial.
Methods. Participants will be randomly assigned in equal number into either the brief hope intervention or the controlled arm on completion of the baseline assessment. Participants of the intervention group will be receiving the four-week intervention, while those allocated to the control arm will be receiving the routine care and social chats. The intervention is a manualized program that consists of four sessions at weekly intervals (two face to face sessions and two telephone follow up in between). The core content is modified from an eight sessions hope therapy. Expert panel feedback and trial on targeted populations were completed. Four participants received the program to determine its acceptability prior to feasibility testing. The process and practical considerations were evaluated to allow refinement of the program and to ensure the quality of intervention.
Outcome measures comprise of changes in state hope score and the depression scores measured respectively by State Hope Scale and Centre for Epidemiological Study Depression Scale. The secondary outcomes are the common signs and symptoms in cancer patients measured by The Condensed Memorial Symptom Assessment Scale. Data collection will be done prior to the intervention (baseline), immediately and one month after the intervention. Additional use of qualitative interview to explore their experiences in the intervention, including satisfaction with the intervention and the treatment fidelity will be conducted.
详细描述
Introduction According to the Medical Research Council guidance, there are four critical steps to systematically establish a standardize intervention content and mode of delivery through phased approach. Theory and evidence-based practice, feasibility or piloting to test the procedure, estimate recruitment/retention, determining sample size, evaluation and implementation are the four keys of the best practice described in the guideline. In this article, we reported three steps in developing an evidence-based intervention, namely brief hope intervention that addresses the management of cancer and palliative care patients: (1) preparation of the present program, (2) description of the protocol of the feasibility test, and (3) an experimental study using wait list control design.
Background Hope intervention is grounded on positive psychology and is mapped onto cognitive-behavioral therapy. It aligns with the 2014-2018 Oncology Nursing Society research priorities, which indicated the need for evaluating the efficacy of integrating protective factors, such as hope, to the care delivery to the patient and family caregivers. In a similar vein, growing evidence has shown the increasing needs of quality palliative care for non-cancer patients, who suffer from complex illnesses and progressing to end-of-life. These patients having unpredictable disease trajectories, significant loss and grief, and anticipated death would lead to depression and hopelessness. As such, the intervention should be extended to non-cancer patients in their last phase of life. The goal of health-promoting palliative care is to create a supportive environment and strengthen actions that intervene along the journey of care giving, loss and death and dying. In a systematic review, hope was found to account for therapeutic changes in clients with depressive symptoms or chronic pain. Nevertheless, such active ingredients of the psychotherapy are not standard elements of multi-modal care management. This warrants the field testing of the present brief hope intervention in patients receiving palliative care.
Hope Theory Hope theory is adopted as the framework in the present study, where hope was believed as the central agent to facilitate the change process. It focuses on three core features: (1) goal setting (goals), (2) problem solving (pathways) and (3) positive self-talk (agency). These elements underlie the key hope strategies used in the intervention. By increasing hope level, the likelihood of therapeutic change will be increased. Its current emphasis complemented the traditional cognitive behavioral therapy by shifting the primary focus on positive potentials as the starting point, thereby promoting meaning in life, fostering personal strengths, positive changes and improving well-being.
Some believed that being overly optimistic is harmful. However, nurturing hope was found to be one of the significant elements in staying positive in the coping experiences of Chinese couples living with cancer. Evidence has shown that high-hope individuals were found to be more creative and effective problem solvers. More important, a number of studies have reported the positive effect of hope in newly diagnosed cancer patient, for example, health, quality of life, self-esteem, reduced major cancer symptoms, such as pain, fatigue, cough, and depression in lung cancer patients or promoting positive changes in breast cancer patients. However, many of these researches are cross-sectional surveys or qualitative studies; others are mindfulness-based or spiritual-based interventions where hope is only one of the active components in the program. Whether improving the hopeful state of cancer patients and palliative care patients would lead to better clinical outcomes remains under explored.
Brief Hope Intervention The present study aimed to examine the effectiveness of a brief hope intervention in improving the hope level and the physical and mental health of cancer and non-cancer Hong Kong Chinese patients who are receiving palliative care. This low intensity psychological intervention can be delivered by caregiver such as nurses to address the needs of these patients and to build their mental and/or physical abilities. Additionally, the skills could be streamlined in daily nursing practice and an ongoing self-help strategy. Would brief hope intervention be as effective as the standard session in clinical population?
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
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years
- •Clinically diagnosed to have cancer or patients receiving palliative care
- •Willing to participate in face-to-face activities and telephone follow up
- •Alert and oriented, able to sustain for approximately one hour of attention and interaction
- •Communicable in Cantonese, able to read and write Chinese
- •Could be reached by phone
排除标准
- •Patients having one or above of the below conditions will be excluded from the study.
- •Patients who have planned operation or further chemotherapy and/or radiotherapy within three months
- •Patients who are unable to communicate in Cantonese
- •Patient who has hearing deficit
- •Patient who are disoriented, delirious or cognitively impaired
- •Patients who have been or is receiving counseling or psychotherapy
- •Patients who are clinically depressed diagnosed by medical doctors
结局指标
主要结局
State Hope Scale (SHS)
时间窗: 4 weeks
The SHS is a self-report instrument consisting of 6 items (Snyder et al., 1996) used to assess the two ongoing hope indices related to the pathways and agency of hopeful thinking. For instance, 'I can think of many ways to reach my current goals'. It takes approximately 5 minutes to complete. It is rated on an 8-point scale with 1 = definitely false and 8 = definitely true.
次要结局
- The Condensed Memorial Symptom Assessment Scale (CMSAS)(4 weeks)
研究者
CHAN Kitty
Lecturer
The Hong Kong Polytechnic University
