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Evaluation on the Effects of a Brief Hope Intervention to the Symptoms in the Palliative Care Patients

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ClinicalTrials.gov Identifier: NCT03021603
Recruitment Status : Not yet recruiting
First Posted : January 16, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
CHAN Kitty, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Psychological Behavioral: Brief Hope Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Intervention Group

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.

Behavioral: Brief Hope Intervention

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.


Experimental: Control Group

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

Behavioral: Brief Hope Intervention

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.





Primary Outcome Measures :
  1. State Hope Scale (SHS) [ Time Frame: 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.


Secondary Outcome Measures :
  1. The Condensed Memorial Symptom Assessment Scale (CMSAS) [ Time Frame: 4 weeks ]
    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.


Other Outcome Measures:
  1. Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: 4 weeks ]
    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.

  2. Healthcare Resource Utilization [ Time Frame: 3 months ]
    Hospital readmission rate, emergency room utilization and mortality rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021603


Contacts
Contact: Kitty Chan, PhD 85227666883 kitty.yy.chan@polyu.edu.hk

Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Chan Kitty, PhD The Hong Kong Polytechnic University

Responsible Party: CHAN Kitty, Lecturer, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03021603     History of Changes
Other Study ID Numbers: HSEARS20160205005
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication of results in May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHAN Kitty, The Hong Kong Polytechnic University:
Hope
psychotherapy
palliative
low-intensity intervention