Clinical trial NCT03021603: Evaluation on the Effects of a Brief Hope Intervention to the Symptoms in the Palliative Care Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological
Keywords: Hope
psychotherapy
palliative
low-intensity intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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?

Optimal Length of Hope Intervention Preliminary evidence was found. Literature showed that the role and value of hope at the early counseling sessions enhanced a literal shift to experience a sense of worthiness. Focused hope intervention (90 minutes) has led to higher level of hope and increase in perceived life meaning. The statistical robustness is supported by the comparable effect sizes achieved by both the eight 2-hours sessions and the 90-minute single session in previous studies on hope therapy. The effect sizes on the agency and pathway hope scale scores were 0.65 and 0.38 respectively in the long intervention, and were 0.43 and 0.38 in the brief interventions. One large scale brief positive psychology intervention with hope-based intervention (single session plus one booster session) recruited 1,734 participants from the community, showed positive significant changes in well-being and family happiness (ES 0.11-0.14) (Zhou et al., 2015). Encouraging results were also demonstrated is other studies, which has tested a brief meaning in life intervention for advanced cancer Chinese patients (2-sessions: 30-60 and 15-30 minutes respectively). It showed improvement in quality of life and existential distress. Wong, Wong, \& Chang (2015) also found a four-sessions program (one visit plus three telephone follow up) effective in reducing hospital readmission in community dwelling patients with chronic illnesses. Nevertheless, there is insufficient evidence on the optimal length of hope intervention for cancer and palliative patients that would produce the desired effect. Thus the present study results could underpin effective palliative care provision across a range of services from hospitalization to discharge facilitation.

Aims The primary research question is whether brief hope intervention would improve the hopeful state and reduce physical symptoms and/or depression level of patients receiving palliative care. Fidelity was assured at the design level and in intervention delivery to establish a standardized procedure, skill adequacy and translating the intervention from research into clinical practice.

Intervention Description of the intervention The present Brief Hope Intervention is a four-weeks individual intervention, helping participants to develop positive thoughts through skills in goal setting, problem solving and positive self-talk. The program consists of four sessions in total: two face-to-face sessions (1-hour) and two telephone follow up sessions (30 minutes) in between. This serves to create the momentum and continuity of intervention. The first session is the core intervention and the final face-to-face session is a summary talk. Two telephone follow up will review their progress and encourage the practice of hope exercises. Hope enhancement strategies included sharing and recalling past successes, hope-based goal mapping exercises, examining possible pathways to reach the targeted goals, hope visualization exercise and positive self-talk. A booklet will be prepared for the participants for reviewing their planned goals and recording achieved targets. Successful experiences and solutions to perceived barriers are entered. Such take-home exercise helps to extend the participants' practice of hope-based skills into their daily living.

Design and Randomization This study is a randomized controlled trial. On completion of the baseline assessment and the screening procedure, eligible participants will be randomly assigned in equal number into either a brief hope intervention or the control group using sets of computer-generated random numbers. The research assistant conducting the assessments will be blinded to the treatment type. However, participants are inevitably aware of the conditions they have been randomized to. To reduce expectancy effects of the advantages of the program, the control arm is casted as a social intervention. Figure 1 presented the data collection using the Consolidated Standards of Reporting Trials, which will be done before the commencement of the intervention (Time1), immediately post-intervention (Time2) and one month after the completion of program (Time 3).

Participants Chinese cancer and non-cancer patients in Hong Kong, who have completed the curative treatment regimen (surgery and/or chemotherapy and/or radiotherapy) or not eligible for the aforementioned treatment, but receiving palliative care will be invited to join the study.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Clinically diagnosed to have cancer or patients receiving palliative care
3. Willing to participate in face-to-face activities and telephone follow up
4. Alert and oriented, able to sustain for approximately one hour of attention and interaction
5. Communicable in Cantonese, able to read and write Chinese
6. Could be reached by phone

Exclusion Criteria:

Patients having one or above of the below conditions will be excluded from the study.

1. Patients who have planned operation or further chemotherapy and/or radiotherapy within three months
2. Patients who are unable to communicate in Cantonese
3. Patient who has hearing deficit
4. Patient who are disoriented, delirious or cognitively impaired
5. Patients who have been or is receiving counseling or psychotherapy
6. Patients who are clinically depressed diagnosed by medical doctors

Primary outcomes:
measure: State Hope Scale (SHS)
timeFrame: 4 weeks
Secondary outcomes:
measure: The Condensed Memorial Symptom Assessment Scale (CMSAS)
timeFrame: 4 weeks
Other outcomes:
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 4 weeks
measure: Healthcare Resource Utilization
timeFrame: 3 months
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Chan Kitty, PhD
role: PRINCIPAL_INVESTIGATOR
References: