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

NCT03021603 | Unknown

• 1 other identifier: HSEARS20160205005
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychological

Keywords

Hope; psychotherapy; palliative; low-intensity intervention

Outcome Measures

Primary Outcomes (1)

• State Hope Scale (SHS)

  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.

  4 weeks

Secondary Outcomes (1)

• The Condensed Memorial Symptom Assessment Scale (CMSAS)

  4 weeks

Other Outcomes (2)

• Center for Epidemiological Studies Depression Scale (CES-D)

  4 weeks

• Healthcare Resource Utilization

  3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

EXPERIMENTAL

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

Interventions

Brief Hope Intervention BEHAVIORAL

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Officials

• Chan Kitty, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kitty Chan, PhD

CONTACT

85227666883; kitty.yy.chan@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 16, 2017
• Study Start: March 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 1, 2018
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share