Clinical trial NCT02723799: Hope Promotion Program: Effectiveness in Palliative Patients
Official title: Promoting Hope at the End of Life: Effectiveness of a Hope Intervention Program in Palliative Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronically Ill
Keywords: Hope
Quality of Life
Comfort
Lead sponsor: Instituto Politécnico de Leiria
Sponsor class: OTHER
Collaborators: name: Universidade Católica Portuguesa
First posted: 2016-03-30
Enrollment: 26
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: This study aims to:

I. Develop and pilot test the effectiveness of a Hope Promotion Program compared with the standard treatment protocol, in hope, comfort and quality of life, based on a population of palliative patients followed at Oncology day care unit.

II. Evaluate perceptions and acceptability of Hope Promotion Program among palliative patients submitted to the intervention program.

Detailed description: Background: Hope is essential in the experience of living with advanced chronic disease. Maintaining hope in situations of physical, psychological, spiritual and social suffering requires expertise and can be very difficult to achieve without the help of professionals, leading to hopelessness, despair and desire to hasten death (Rodin et al., 2007;Breitbart, 2000; Monforte-Royo, et al., 2012) The research team has designed an intervention program - Hope Promotion Program (HPP) to increase hope, comfort and quality of life in palliative patients. HPP consists of a three session's individual interventions carried out by the researcher in patients homes. The first session includes viewing the film Hopeful Living, produced by the research team, inspired by Duggleby et al, (2007) which features palliative patients, caregivers and health professionals describing their experiences of hope. The second session consists of patients' expression of feelings and emotions related with experience of living with a chronic advanced disease and the choice of a hope activity from the Hope activity book - a collection of hope activities specially designed for people living with an advanced chronic disease. The third session includes a relaxation activity and a plan to include hope exercise in patients' activities of daily living.

This project was designed according to the literature review of hope interventions and have the potential to become part of palliative care interventions evidenced based.

Aims: The purpose of this study is to evaluate the acceptability and feasibility and collect preliminary data on the effectiveness of the Hope Promotion Program for persons in palliative situation residing at home.

Moreover this project will allow to a) Obtain relevant information about hope, comfort and quality of life of palliative patients; b) Tailor therapeutic strategies to individual needs; c) increase hope, comfort and quality of life in patients at the end of life.

Sample: Patients with a chronic advanced disease in palliative situation, recruited from Oncology day care units of two district hospital in the centre of Portugal. Inclusion criterion for participants are: a) 18 years of age and older, b) Portuguese speaking, c) have cognitive capacity to participate in the study (MMSE\>15) and d) have agreed to participate in the study. An interview with a nurse precede the inclusion in the study to explain the study and obtain written informed consent.

Design: This study is designed as a mix-methods randomized clinical trial (Quantitative +Qualitative) design. Patients eligible, are randomly assigned to one of two groups: 1) treatment (Hope Promotion Program delivered by a nurse in three sessions during one week), 2) usual care group.

In all groups, demographic information and measures of hope (Herth Hope Index), quality of life (McGillQOL), Comfort (Hospice Comfort Questionnaire) will be collected by a trained research nurse at baseline, day 15 and one month. Participants in group 1 (treatment group) will be asked to describe what they were thinking about when doing the hope activities on day 15 and one month using qualitative interviews. At one month all participants will be interviewed using open ended audiotaped questions to help evaluate the program and study procedures.

Eligibility criteria: Inclusion Criteria:

* Portuguese speaking
* Have a chronic advanced disease non-responding to treatment, metastatic disease, episodes of non-controlled symptoms
* Have health care assistance by a health care team in an outpatient setting
* Cognitive ability to answer the questionnaires (MMSE\>15 for illiterate participants, \>22 for participants with 11 years of schooling, \>27 for participants with more than 11 years of schooling)
* Consenting to voluntarily participate in the study.

Exclusion Criteria:

* Patients with high suffering from uncontrolled and recurrent presence of symptoms (nausea, vomiting, pain),
* Patients with performance status under 30, due to their particularly vulnerability, intervention would need energy required to vital functions.

Primary outcomes:
measure: Hope measured by the Portuguese version of Herth Hope Index
timeFrame: Change from baseline at day 15 and 30
Secondary outcomes:
measure: Comfort measured by Portuguese version of Hospice Comfort Questionnaire
timeFrame: Change from baseline at day 15 and 30
measure: Quality of Life measured by the Portuguese version of McGill Quality of Life Questionnaire (MQOL-PT-DC)
timeFrame: Change from baseline at day 15 and 30
Other outcomes:
Locations:
Study officials:
References:
citation: Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.