<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03021603</url>
  </required_header>
  <id_info>
    <org_study_id>HSEARS20160205005</org_study_id>
    <nct_id>NCT03021603</nct_id>
  </id_info>
  <brief_title>Evaluation on the Effects of a Brief Hope Intervention to the Symptoms in the Palliative Care Patients</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims. This paper describes the study protocol of a manualized brief positive intervention&#xD;
      (BHI). In addition, it reports the on the modification of a hope intervention based on the&#xD;
      theoretical proposition - hope theory, and its feasibility when applying to palliative cancer&#xD;
      and non-cancer patients.&#xD;
&#xD;
      Background. Hope was found to account for therapeutic changes in clients with depressive&#xD;
      symptoms or chronic pain. Nevertheless, little is known about the integration of such active&#xD;
      ingredients to brief and low intensity psycho-therapeutic interventions to patients receiving&#xD;
      palliative care were not adequately tested.&#xD;
&#xD;
      Design. The study included two stages: (1) manual development, and (2) a single blinded&#xD;
      randomized controlled trial.&#xD;
&#xD;
      Methods. Participants will be randomly assigned in equal number into either the brief hope&#xD;
      intervention or the controlled arm on completion of the baseline assessment. Participants of&#xD;
      the intervention group will be receiving the four-week intervention, while those allocated to&#xD;
      the control arm will be receiving the routine care and social chats. The intervention is a&#xD;
      manualized program that consists of four sessions at weekly intervals (two face to face&#xD;
      sessions and two telephone follow up in between). The core content is modified from an eight&#xD;
      sessions hope therapy. Expert panel feedback and trial on targeted populations were&#xD;
      completed. Four participants received the program to determine its acceptability prior to&#xD;
      feasibility testing. The process and practical considerations were evaluated to allow&#xD;
      refinement of the program and to ensure the quality of intervention.&#xD;
&#xD;
      Outcome measures comprise of changes in state hope score and the depression scores measured&#xD;
      respectively by State Hope Scale and Centre for Epidemiological Study Depression Scale. The&#xD;
      secondary outcomes are the common signs and symptoms in cancer patients measured by The&#xD;
      Condensed Memorial Symptom Assessment Scale. Data collection will be done prior to the&#xD;
      intervention (baseline), immediately and one month after the intervention. Additional use of&#xD;
      qualitative interview to explore their experiences in the intervention, including&#xD;
      satisfaction with the intervention and the treatment fidelity will be conducted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction According to the Medical Research Council guidance, there are four critical&#xD;
      steps to systematically establish a standardize intervention content and mode of delivery&#xD;
      through phased approach. Theory and evidence-based practice, feasibility or piloting to test&#xD;
      the procedure, estimate recruitment/retention, determining sample size, evaluation and&#xD;
      implementation are the four keys of the best practice described in the guideline. In this&#xD;
      article, we reported three steps in developing an evidence-based intervention, namely brief&#xD;
      hope intervention that addresses the management of cancer and palliative care patients: (1)&#xD;
      preparation of the present program, (2) description of the protocol of the feasibility test,&#xD;
      and (3) an experimental study using wait list control design.&#xD;
&#xD;
      Background Hope intervention is grounded on positive psychology and is mapped onto&#xD;
      cognitive-behavioral therapy. It aligns with the 2014-2018 Oncology Nursing Society research&#xD;
      priorities, which indicated the need for evaluating the efficacy of integrating protective&#xD;
      factors, such as hope, to the care delivery to the patient and family caregivers. In a&#xD;
      similar vein, growing evidence has shown the increasing needs of quality palliative care for&#xD;
      non-cancer patients, who suffer from complex illnesses and progressing to end-of-life. These&#xD;
      patients having unpredictable disease trajectories, significant loss and grief, and&#xD;
      anticipated death would lead to depression and hopelessness. As such, the intervention should&#xD;
      be extended to non-cancer patients in their last phase of life. The goal of health-promoting&#xD;
      palliative care is to create a supportive environment and strengthen actions that intervene&#xD;
      along the journey of care giving, loss and death and dying. In a systematic review, hope was&#xD;
      found to account for therapeutic changes in clients with depressive symptoms or chronic pain.&#xD;
      Nevertheless, such active ingredients of the psychotherapy are not standard elements of&#xD;
      multi-modal care management. This warrants the field testing of the present brief hope&#xD;
      intervention in patients receiving palliative care.&#xD;
&#xD;
      Hope Theory Hope theory is adopted as the framework in the present study, where hope was&#xD;
      believed as the central agent to facilitate the change process. It focuses on three core&#xD;
      features: (1) goal setting (goals), (2) problem solving (pathways) and (3) positive self-talk&#xD;
      (agency). These elements underlie the key hope strategies used in the intervention. By&#xD;
      increasing hope level, the likelihood of therapeutic change will be increased. Its current&#xD;
      emphasis complemented the traditional cognitive behavioral therapy by shifting the primary&#xD;
      focus on positive potentials as the starting point, thereby promoting meaning in life,&#xD;
      fostering personal strengths, positive changes and improving well-being.&#xD;
&#xD;
      Some believed that being overly optimistic is harmful. However, nurturing hope was found to&#xD;
      be one of the significant elements in staying positive in the coping experiences of Chinese&#xD;
      couples living with cancer. Evidence has shown that high-hope individuals were found to be&#xD;
      more creative and effective problem solvers. More important, a number of studies have&#xD;
      reported the positive effect of hope in newly diagnosed cancer patient, for example, health,&#xD;
      quality of life, self-esteem, reduced major cancer symptoms, such as pain, fatigue, cough,&#xD;
      and depression in lung cancer patients or promoting positive changes in breast cancer&#xD;
      patients. However, many of these researches are cross-sectional surveys or qualitative&#xD;
      studies; others are mindfulness-based or spiritual-based interventions where hope is only one&#xD;
      of the active components in the program. Whether improving the hopeful state of cancer&#xD;
      patients and palliative care patients would lead to better clinical outcomes remains under&#xD;
      explored.&#xD;
&#xD;
      Brief Hope Intervention The present study aimed to examine the effectiveness of a brief hope&#xD;
      intervention in improving the hope level and the physical and mental health of cancer and&#xD;
      non-cancer Hong Kong Chinese patients who are receiving palliative care. This low intensity&#xD;
      psychological intervention can be delivered by caregiver such as nurses to address the needs&#xD;
      of these patients and to build their mental and/or physical abilities. Additionally, the&#xD;
      skills could be streamlined in daily nursing practice and an ongoing self-help strategy.&#xD;
      Would brief hope intervention be as effective as the standard session in clinical population?&#xD;
&#xD;
      Optimal Length of Hope Intervention Preliminary evidence was found. Literature showed that&#xD;
      the role and value of hope at the early counseling sessions enhanced a literal shift to&#xD;
      experience a sense of worthiness. Focused hope intervention (90 minutes) has led to higher&#xD;
      level of hope and increase in perceived life meaning. The statistical robustness is supported&#xD;
      by the comparable effect sizes achieved by both the eight 2-hours sessions and the 90-minute&#xD;
      single session in previous studies on hope therapy. The effect sizes on the agency and&#xD;
      pathway hope scale scores were 0.65 and 0.38 respectively in the long intervention, and were&#xD;
      0.43 and 0.38 in the brief interventions. One large scale brief positive psychology&#xD;
      intervention with hope-based intervention (single session plus one booster session) recruited&#xD;
      1,734 participants from the community, showed positive significant changes in well-being and&#xD;
      family happiness (ES 0.11-0.14) (Zhou et al., 2015). Encouraging results were also&#xD;
      demonstrated is other studies, which has tested a brief meaning in life intervention for&#xD;
      advanced cancer Chinese patients (2-sessions: 30-60 and 15-30 minutes respectively). It&#xD;
      showed improvement in quality of life and existential distress. Wong, Wong, &amp; Chang (2015)&#xD;
      also found a four-sessions program (one visit plus three telephone follow up) effective in&#xD;
      reducing hospital readmission in community dwelling patients with chronic illnesses.&#xD;
      Nevertheless, there is insufficient evidence on the optimal length of hope intervention for&#xD;
      cancer and palliative patients that would produce the desired effect. Thus the present study&#xD;
      results could underpin effective palliative care provision across a range of services from&#xD;
      hospitalization to discharge facilitation.&#xD;
&#xD;
      Aims The primary research question is whether brief hope intervention would improve the&#xD;
      hopeful state and reduce physical symptoms and/or depression level of patients receiving&#xD;
      palliative care. Fidelity was assured at the design level and in intervention delivery to&#xD;
      establish a standardized procedure, skill adequacy and translating the intervention from&#xD;
      research into clinical practice.&#xD;
&#xD;
      Intervention Description of the intervention The present Brief Hope Intervention is a&#xD;
      four-weeks individual intervention, helping participants to develop positive thoughts through&#xD;
      skills in goal setting, problem solving and positive self-talk. The program consists of four&#xD;
      sessions in total: two face-to-face sessions (1-hour) and two telephone follow up sessions&#xD;
      (30 minutes) in between. This serves to create the momentum and continuity of intervention.&#xD;
      The first session is the core intervention and the final face-to-face session is a summary&#xD;
      talk. Two telephone follow up will review their progress and encourage the practice of hope&#xD;
      exercises. Hope enhancement strategies included sharing and recalling past successes,&#xD;
      hope-based goal mapping exercises, examining possible pathways to reach the targeted goals,&#xD;
      hope visualization exercise and positive self-talk. A booklet will be prepared for the&#xD;
      participants for reviewing their planned goals and recording achieved targets. Successful&#xD;
      experiences and solutions to perceived barriers are entered. Such take-home exercise helps to&#xD;
      extend the participants' practice of hope-based skills into their daily living.&#xD;
&#xD;
      Design and Randomization This study is a randomized controlled trial. On completion of the&#xD;
      baseline assessment and the screening procedure, eligible participants will be randomly&#xD;
      assigned in equal number into either a brief hope intervention or the control group using&#xD;
      sets of computer-generated random numbers. The research assistant conducting the assessments&#xD;
      will be blinded to the treatment type. However, participants are inevitably aware of the&#xD;
      conditions they have been randomized to. To reduce expectancy effects of the advantages of&#xD;
      the program, the control arm is casted as a social intervention. Figure 1 presented the data&#xD;
      collection using the Consolidated Standards of Reporting Trials, which will be done before&#xD;
      the commencement of the intervention (Time1), immediately post-intervention (Time2) and one&#xD;
      month after the completion of program (Time 3).&#xD;
&#xD;
      Participants Chinese cancer and non-cancer patients in Hong Kong, who have completed the&#xD;
      curative treatment regimen (surgery and/or chemotherapy and/or radiotherapy) or not eligible&#xD;
      for the aforementioned treatment, but receiving palliative care will be invited to join the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>State Hope Scale (SHS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Condensed Memorial Symptom Assessment Scale (CMSAS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The CMSAS a an abbreviated version of the short form MSAS-SF (Chinese version). The instrument measures 14 prevalent symptoms and comprises of two subscales: (1) Physical Symptom (CMSAS PHYS -11 items), (2) Psychological Symptom (CMSAS PSYCH - 3 items), and total score of the CMSAS (CMSAS SUM). Physical symptoms included lack of energy, lack of appetite, pain, dry mouth, weight loss, feeling drowsy, shortness of breath, constipation, difficulty sleeping, difficulty concentrating, and nausea. The psychological symptoms include worrying, feeling sad, and feeling nervous. The items were scored on a 5-point Likert scale from 0 = not at all to 4 = very much.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Center for Epidemiological Studies Depression Scale (CES-D)</measure>
    <time_frame>4 weeks</time_frame>
    <description>CES-D is a 20-item self-report scale measures the frequency of occurrence of depressed mood within one week is in a response format of 4-point Likert scale. The four options are 'rarely or none of the time' (less than 1 days); &quot;some or a little of the time' (1-2 days), &quot;occasionally or a moderate amount of the time&quot; (3-4 days); and &quot;most or all of the time&quot; (5-7 days). Total scores ranging from 0 to 60, with higher ratings denoting higher frequency of depressive symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare Resource Utilization</measure>
    <time_frame>3 months</time_frame>
    <description>Hospital readmission rate, emergency room utilization and mortality rate</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Psychological</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a 4-week Brief Hope Intervention&#xD;
Four sessions in total:&#xD;
two face-to-face sessions (1-hour) and two telephone follow up sessions (30 mins) in between.&#xD;
Homework : A booklet is prepared for the participants for reviewing their planned goals and recording achieved targets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard care:&#xD;
Clinic follow up and normal hospital care. Logistic call and social communication On completion of the 4-week standard care, the 4-session brief hope intervention will be offered</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Hope Intervention</intervention_name>
    <description>The present Brief Hope Intervention (BHI) is a four-weeks individual intervention:&#xD;
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.&#xD;
Purpose: help participants to develop positive thoughts.&#xD;
The programme consists of four sessions:&#xD;
Two face-to-face sessions (1-hour) and two telephone follow up (30 mins) Homework: A booklet is prepared for the participants for reviewing their planned goals and recording achieved targets.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Clinically diagnosed to have cancer or patients receiving palliative care&#xD;
&#xD;
          3. Willing to participate in face-to-face activities and telephone follow up&#xD;
&#xD;
          4. Alert and oriented, able to sustain for approximately one hour of attention and&#xD;
             interaction&#xD;
&#xD;
          5. Communicable in Cantonese, able to read and write Chinese&#xD;
&#xD;
          6. Could be reached by phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients having one or above of the below conditions will be excluded from the study.&#xD;
&#xD;
          1. Patients who have planned operation or further chemotherapy and/or radiotherapy within&#xD;
             three months&#xD;
&#xD;
          2. Patients who are unable to communicate in Cantonese&#xD;
&#xD;
          3. Patient who has hearing deficit&#xD;
&#xD;
          4. Patient who are disoriented, delirious or cognitively impaired&#xD;
&#xD;
          5. Patients who have been or is receiving counseling or psychotherapy&#xD;
&#xD;
          6. Patients who are clinically depressed diagnosed by medical doctors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chan Kitty, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kitty Chan, PhD</last_name>
    <phone>85227666883</phone>
    <email>kitty.yy.chan@polyu.edu.hk</email>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>CHAN Kitty</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Hope</keyword>
  <keyword>psychotherapy</keyword>
  <keyword>palliative</keyword>
  <keyword>low-intensity intervention</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publication of results in May 2018</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03021603
org study id: HSEARS20160205005
nct id: NCT03021603
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: State Hope Scale (SHS)
time frame: 4 weeks
description: 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.
measure: The Condensed Memorial Symptom Assessment Scale (CMSAS)
time frame: 4 weeks
description: The CMSAS a an abbreviated version of the short form MSAS-SF (Chinese version). The instrument measures 14 prevalent symptoms and comprises of two subscales: (1) Physical Symptom (CMSAS PHYS -11 items), (2) Psychological Symptom (CMSAS PSYCH - 3 items), and total score of the CMSAS (CMSAS SUM). Physical symptoms included lack of energy, lack of appetite, pain, dry mouth, weight loss, feeling drowsy, shortness of breath, constipation, difficulty sleeping, difficulty concentrating, and nausea. The psychological symptoms include worrying, feeling sad, and feeling nervous. The items were scored on a 5-point Likert scale from 0 = not at all to 4 = very much.
measure: Center for Epidemiological Studies Depression Scale (CES-D)
time frame: 4 weeks
description: CES-D is a 20-item self-report scale measures the frequency of occurrence of depressed mood within one week is in a response format of 4-point Likert scale. The four options are 'rarely or none of the time' (less than 1 days); "some or a little of the time' (1-2 days), "occasionally or a moderate amount of the time" (3-4 days); and "most or all of the time" (5-7 days). Total scores ranging from 0 to 60, with higher ratings denoting higher frequency of depressive symptoms.
measure: Healthcare Resource Utilization
time frame: 3 months
description: Hospital readmission rate, emergency room utilization and mortality rate
arm group label: Intervention Group
arm group type: Experimental
description: This is a 4-week Brief Hope Intervention
Four sessions in total:
two face-to-face sessions (1-hour) and two telephone follow up sessions (30 mins) in between.
Homework : A booklet is prepared for the participants for reviewing their planned goals and recording achieved targets.
arm group label: Control Group
arm group type: Experimental
description: Standard care:
Clinic follow up and normal hospital care. Logistic call and social communication On completion of the 4-week standard care, the 4-session brief hope intervention will be offered
intervention type: Behavioral
intervention name: Brief Hope Intervention
description: The present Brief Hope Intervention (BHI) is a four-weeks individual intervention:
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.
Purpose: help participants to develop positive thoughts.
The programme consists of four sessions:
Two face-to-face sessions (1-hour) and two telephone follow up (30 mins) Homework: A booklet is prepared for the participants for reviewing their planned goals and recording achieved targets.
arm group label: Control Group
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chan Kitty, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
last name: Kitty Chan, PhD
phone: 85227666883
email: kitty.yy.chan@polyu.edu.hk
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: CHAN Kitty
investigator title: Lecturer
sharing ipd: Yes
ipd description: Publication of results in May 2018