Chronically IllHPPNCT02723799
Hope Promotion Program: Effectiveness in Palliative Patients
A study testing Hope Promotion Program (HPP) and Standard Treatment Protocol in people with Chronically Ill, run by Instituto Politécnico de Leiria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronically Ill
- What is being tested?
- Hope Promotion Program (HPP) and Standard Treatment Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Promoting Hope at the End of Life: Effectiveness of a Hope Intervention Program in Palliative Patients
This study aims to:
- 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.
Read the 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.
- Conditions
- Chronically Ill
- Being tested
- Hope Promotion Program (HPP), Standard Treatment Protocol
- Keywords
- Hope, Quality of Life, Comfort
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hope Promotion Program (HPP)Behavioural
HPP is based on literature review and qualitative research in hope at the end-of-life. The film "Hopeful living" reflects the findings of the grounded theory study. Hope activity book is the final product of the literature review on hope interventions and its activities were tested in their feasibility and suitability in our previous research with persons with advanced cancer and their families.
Standard Treatment ProtocolOther
Regular assessment and care by the hospital outpatient health care team.
| Study group | Role | What they receive |
|---|---|---|
| Hope Promotion Program (HPP) | Experimental | Plus to the standard treatment protocol, all the participants in this group attend the HPP, consisting of a three individual session's carried out by the nurse in patients' homes. It includes viewing the film Hopeful Living, enrolling in a hope activity from the Hope activity book, a relaxation activity and a negotiated plan to exercise hope in a regular basis. Receives: Behavioral: Hope Promotion Program (HPP); Other: Standard Treatment Protocol |
| Standard Treatment Protocol | Other | Participants in this group has not access to a hope intervention. Data collection for outcome variables is the same as the participants in the other arms. Receives: Other: Standard Treatment Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hope measured by the Portuguese version of Herth Hope Index
Hope is measured by the Portuguese version of Herth Hope Index for chronic conditions (HHI-PT-DC). The HHI-PT-DC is a 10 item (1-4 point) Likert scale that delineates two sub-scales of hope: a) temporality, trust and interconnection, b) positive readiness and expectancy. The HHI-PT-DC takes approximately 5 minutes to complete. Summative scores range from 10-40, with a higher score denoting greater hope.
Measured: Change from baseline at day 15 and 30
Secondary outcomes (2)
Comfort measured by Portuguese version of Hospice Comfort Questionnaire
Comfort is measured by Portuguese version of Hospice Comfort Questionnaire, based on holistic comfort questionnaire, developed by Kolcaba (HCQ-PT-DC). This instrument is composed by 26 items (1-6 points) Likert-scale that addresses the three states of comfort: relief, ease and transcendence. The higher the score, the higher the subjects' reported comfort.
Measured: Change from baseline at day 15 and 30
Quality of Life measured by the Portuguese version of McGill Quality of Life Questionnaire (MQOL-PT-DC)
Quality of Life is measured by the Portuguese version of McGill Quality of Life Questionnaire (MQOL-PT-DC). The MQOL-PT-DC is a quality of life assessment measure reflecting 4 domains of quality of life: physical health, psychological symptoms, existential well-being, and support. The MQOL-PT-DC is comprised of 16 items, assessed in a self-rating numerical scale (0-10) and Single Item Scale (0-10) to assess subjective quality of life. Higher scores indicates better QOL.
Measured: Change from baseline at day 15 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Católica Portuguesa
- Responsible party
- Principal investigator, Ana Querido, Instituto Politécnico de Leiria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723799
- Sponsor's protocol ID
- Ana Querido - IPLeiria
- Acronym
- HPP
- Status last verified
- Jan 2023
- First submitted
- 14 Mar 2016
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35802350
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Hope at the End of Life: Effectiveness of a Hope Intervention Program in Palliative Patients
- ClinicalTrials.gov ID
- NCT02723799
- Acronym / sponsor ID
- HPP / Ana Querido - IPLeiria
- Conditions
- Chronically Ill
- Keywords
- Hope, Quality of Life, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Collaborators
- Universidade Católica Portuguesa
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hope Promotion Program (HPP) | Experimental | Behavioral: Hope Promotion Program (HPP), Other: Standard Treatment ProtocolPlus to the standard treatment protocol, all the participants in this group attend the HPP, consisting of a three individual session's carried out by the nurse in patients' homes. It includes viewing the film Hopeful Living, enrolling in a hope activity from the Hope activity book, a relaxation activity and a negotiated plan to exercise hope in a regular basis. |
| Standard Treatment Protocol | Other | Other: Standard Treatment ProtocolParticipants in this group has not access to a hope intervention. Data collection for outcome variables is the same as the participants in the other arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hope Promotion Program (HPP)HPP is based on literature review and qualitative research in hope at the end-of-life. The film "Hopeful living" reflects the findings of the grounded theory study. Hope activity book is the final product of the literature review on hope interventions and its activities were tested in their feasibility and suitability in our previous research with persons with advanced cancer and their families. | Behavioural | Hope Promotion Program (HPP) |
| Standard Treatment ProtocolRegular assessment and care by the hospital outpatient health care team. | Other | Hope Promotion Program (HPP), Standard Treatment Protocol |
Primary outcome
Hope measured by the Portuguese version of Herth Hope Index
Time frame: Change from baseline at day 15 and 30
Hope is measured by the Portuguese version of Herth Hope Index for chronic conditions (HHI-PT-DC). The HHI-PT-DC is a 10 item (1-4 point) Likert scale that delineates two sub-scales of hope: a) temporality, trust and interconnection, b) positive readiness and expectancy. The HHI-PT-DC takes approximately 5 minutes to complete. Summative scores range from 10-40, with a higher score denoting greater hope.
2 secondary outcomes
Comfort measured by Portuguese version of Hospice Comfort Questionnaire
Time frame: Change from baseline at day 15 and 30
Quality of Life measured by the Portuguese version of McGill Quality of Life Questionnaire (MQOL-PT-DC)
Time frame: Change from baseline at day 15 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Derived from this study: PubMed 35802350Ryan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hope Promotion Program (HPP) and Standard Treatment Protocol in people with Chronically Ill, run by Instituto Politécnico de Leiria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hope measured by the Portuguese version of Herth Hope Index (time frame: Change from baseline at day 15 and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02723799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.