Palliative CareIPBGNCT03703687
Impact of a Gratitude-based Intervention in Palliative Care (IPBG)
A study testing Gratitude intervention in people with Palliative Care, run by Centre Hospitalier Universitaire Vaudois at 3 sites in Switzerland.
Trial summary
This is a pilot study consisting of mixed-methods, pre-post evaluation of a gratitude intervention (gratitude letter and visit) on palliative care patients and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- Gratitude intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 27 Nov 2018to 8 Oct 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Only patients fulfilling all of the following inclusion criteria are eligible for the study:
- Age >18
- progressive disease
- reduced life expectancy
- enrolment in palliative care
- stable state for the previous 24h assessed by the physician or the nurse in charge of the patient
- informed consent signed by patient
- For each patient, the identification of a close family or friend caregiver (fulfilling the below criteria*) and who accepts to participate in the trial (by signing an informed consent)
In this research, a caregiver is defined as "a person who devotes time to help a family member or a friend affected in her/his health or autonomy. The caregiver assures, in a non-professional and regular way, a presence and a support to help her/him in his difficulties and assures her/his safety. The caregiver can be a friend, a family member or a neighbour" (Vaud canton definition). This definition will be the basis for the palliative patient to identify his caregiver.
The presence of any one of the following exclusion criteria will lead to exclusion of the patient:
- Person completely isolated socially, no family or friend caregiver identified
- Significant cognitive or psychiatric disorders which would affect the ability to give informed consent for this research
- Severe communication problems (foreign language, deafness, etc.).
Only caregivers fulfilling all of the following inclusion criteria are eligible for the study:
- Age >18
- Identified as the caregiver by the palliative patient (see above)
- prior agreement of the patient for the participation of the caregiver
The presence of any one of the following exclusion criteria will lead to exclusion of the caregivers:
- Psychiatric and cognitive disorders which would affect the ability to give informed consent for this research based on the information reported by the clinical team in charge of the patient and the personal evaluation of the research collaborator.
- Communication problems (foreign language, deafness, etc.).
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Rive-Neuve Foundation
Blonay, Canton of Vaud, 1807
Fribourg University hospital, Unité et Accueil de jour de soins palliatifs
Fribourg, 1708
Lausanne University hospital, Palliative and supportive care service
Lausanne, Canton of Vaud, 1011
About this study
Official title: Impact of a Gratitude-based Intervention on Patients and Caregivers in a Palliative Care Context: a Pilot Study
This is a pilot study consisting of mixed-methods, pre-post evaluation of a gratitude intervention (gratitude letter and visit) on palliative care patients and their caregivers.
Read the detailed description
Study background and aims:
Gratitude, defined as an "other-oriented" emotion, has shown to impact significantly on many relevant dimensions for palliative care (e.g. well-being, psychological distress and the quality of relationships). Various psychological interventions focused on the enhancement of the feeling of gratitude have been developed and assessed but mostly in non-clinical populations and never taking into account the relationship dimension as an outcome.
The fact that the relational component has never been addressed in interventional studies is all the more surprising since several experimental and non-clinical studies have clearly shown an association between gratitude and feeling of social affiliation, relational commitment, satisfaction with relationships or partner reciprocal maintenance behaviours. These results appear to be very promising for palliative care since interpersonal (and particularly familial) relationships are crucial for palliative care patients: the relational sphere represents a major predictor contributing to both their meaning in life and their quality of life. We hypothesize that considering this concept in palliative care could benefit both the patients and their relatives.
Thus, the purpose of this research is to conduct a pilot study before a possible randomized controlled multicenter trial whose final aim will be to examine whether a gratitude-based intervention in a palliative care setting can increase the quality of life and the quality of the relationship of patients and their caregivers and decrease their psychological distress and burden.
The specific aims of this pilot study are:
(i) to realize a cross-cultural translation of outcome measures that are not yet available in French (ii) to establish the feasibility of the study design (iii) to investigate the appropriateness of the gratitude concept and the gratitude-based intervention in the palliative care context, and finally (iv) to explore the sensitivity to change of our selected measures in order to calculate a sample size.
Procedure and measures:
Quantitative data will be collected at baseline (T0) and post-intervention (T1) with validated questionnaires. The intervention will last for one week. Five to ten days after T1, qualitative data will be collected from semi-structured interviews with the participants and from the content of the gratitude letters to explore their representations of the gratitude concept and their perception of the intervention.
The intervention includes the following steps:
- Patients and caregivers recruitment: The clinical team (treating physician or advanced practice nurse) at each recruitment site will identify 10 patient-caregivers dyads. A research collaborator will then be in charge of giving information and get consent
- Data collection at T0: Before the intervention, patients and their caregivers who agreed to participate will meet the research collaborator to fill quantitative questionnaires.
- Intervention - 1-week duration: The intervention will be proposed to both the patient and the caregiver and consists of two steps: the "gratitude letter" and the "gratitude visit". In the "gratitude letter", the participant (at least one of the patient or the caregiver) writes about his feelings of gratitude through a letter, based on a written instruction. The "gratitude visit" consists of an extension of the gratitude letter where the writer of the letter (i) either personally reads the letter to the beneficent or (ii) gives it to him and asks him to read it in his presence or later in his absence.
- Data collection at T1: 5 to 10 days after the intervention itself, the patient and the caregiver, will meet with the research collaborator again to participate to a second quantitative assessment, similar to T0.
- Qualitative assessment: 5 to 15 days after T1: This part is facultative. During the qualitative interviews, the following topics will be explored: their meanings of the term "gratitude"; experiences of gratitude; their experience of the intervention itself; obstacles and facilitators of the intervention; the impact of the intervention for themselves and for their relationship.
- Conditions
- Palliative Care
- Being tested
- Gratitude intervention
- Keywords
- palliative care, gratitude, positive psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gratitude interventionBehavioural
Also called gratitude letter, gratitude visit
The intervention will be proposed to both the patient and the caregiver and consists of two steps: the "gratitude letter" and the "gratitude visit". In the "gratitude letter", the individual writes about his feelings of gratitude through a letter, based on a written instruction. The "gratitude visit" consists of an extension of the gratitude letter where the writer of the letter (i) either personally reads the letter to the beneficent or (ii) gives it to him and asks him to read it in his presence or later in his absence.
| Study group | Role | What they receive |
|---|---|---|
| Gratitude intervention | Experimental | The intervention will be proposed to both the patient and the caregiver and consists of two steps: the "gratitude letter" and the "gratitude visit". In the "gratitude letter", the individual writes about his feelings of gratitude through a letter, based on a written instruction. The "gratitude visit" consists of an extension of the gratitude letter where the writer of the letter (i) either personally reads the letter to the beneficent or (ii) gives it to him and asks him to read it in his presence or later in his absence. Receives: Behavioral: Gratitude intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relationship quality for patients and caregivers
The quality of the relationship between the palliative patient and his/her caregiver will be measured with the Couple Satisfaction Index (CSI-4; "total score" range from 0 to 21, higher scores indicating a better quality of relationship).
Measured: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in relationship quality for patients and caregivers
The quality of the relationship between the palliative patient and his/her caregiver will be also measured with the Positive Negative Relationship Quality Scale (PNRQ; "positive subscale" range from 0 to 48 and "negative subscale" range from 0 to 48, with higher scores indicating higher quality of relationship).
Measured: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Secondary outcomes (6)
Change in subjective quality of life for patients
The quality of life will be measured with the McGill Quality of Life scale Revised version (MQOL-R; all subscales range from 0 to 10: "global quality of life", "physical", "psychological", "existential", "relationships", and "total score", with higher scores indicating higher quality of life)
Measured: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in subjective quality of life for caregivers
The quality of life will be measured with the Quality of Life in Life-Threatening Illness - Family Carer Version 2 (QOLLTI-F V2; all subscales range from 0 to 10: "global quality of life", "environment", "patient condition", "own condition", "outlook", "quality of care", "relationships", "financial worries", and "total score", with higher scores indicating higher quality of life)
Measured: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in psychological distress for patients
Psychological distress will be measured with the Hospital Anxiety and Depression Scale (HADS; "total score" range from 0 to 42; "anxiety subscale" from 0 to 21, and "depression subscale" from 0 to 21, with higher scores indicating higher distress)
Measured: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in psychological distress for caregivers
Psychological distress will be measured with the Brief Symptom Inventory 18 (BSI 18; "total score" range from 0 to 72, "somatic subscale" range from 0 to 24, "depression subscale" range from 0 to 24, "anxiety subscale" from 0 to 12; and "panic subscale" from 0 to 12, with higher scores indicating higher distress).
Measured: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in burden for patients
Burden will be measured with the Self Perceived Burden Scale (SPBS, "total score" range from 10 to 50, with higher scores indicating higher burden).
Measured: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in burden for caregivers
Burden will be measured with the 10-item short version of the Burden Scale for Family Caregivers (BSFC-s, "total score" from 0 to 30, with higher score indicating higher burden).
Measured: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start27 Nov 2018
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical trial has a single arm: all the dyads will go through all the steps (apart from the qualitative assessment which are facultatives).
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu BERNARD, Centre Hospitalier Universitaire Vaudois
- Investigators
- Mathieu Bernard, Principal investigator, Palliative and Supportive care service of the Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703687
- Sponsor's protocol ID
- IPBG2018-2020
- Acronym
- IPBG
- Status last verified
- Dec 2020
- First submitted
- 28 Sep 2018
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided up to now
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Gratitude-based Intervention on Patients and Caregivers in a Palliative Care Context: a Pilot Study
- ClinicalTrials.gov ID
- NCT03703687
- Acronym / sponsor ID
- IPBG / IPBG2018-2020
- Conditions
- Palliative Care
- Keywords
- palliative care, gratitude, positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 12 Oct 2018 (actual)
- 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 is a pilot study consisting of mixed-methods, pre-post evaluation of a gratitude intervention (gratitude letter and visit) on palliative care patients and their caregivers.
Detailed description
Study background and aims:
Gratitude, defined as an "other-oriented" emotion, has shown to impact significantly on many relevant dimensions for palliative care (e.g. well-being, psychological distress and the quality of relationships). Various psychological interventions focused on the enhancement of the feeling of gratitude have been developed and assessed but mostly in non-clinical populations and never taking into account the relationship dimension as an outcome.
The fact that the relational component has never been addressed in interventional studies is all the more surprising since several experimental and non-clinical studies have clearly shown an association between gratitude and feeling of social affiliation, relational commitment, satisfaction with relationships or partner reciprocal maintenance behaviours. These results appear to be very promising for palliative care since interpersonal (and particularly familial) relationships are crucial for palliative care patients: the relational sphere represents a major predictor contributing to both their meaning in life and their quality of life. We hypothesize that considering this concept in palliative care could benefit both the patients and their relatives.
Thus, the purpose of this research is to conduct a pilot study before a possible randomized controlled multicenter trial whose final aim will be to examine whether a gratitude-based intervention in a palliative care setting can increase the quality of life and the quality of the relationship of patients and their caregivers and decrease their psychological distress and burden.
The specific aims of this pilot study are:
(i) to realize a cross-cultural translation of outcome measures that are not yet available in French (ii) to establish the feasibility of the study design (iii) to investigate the appropriateness of the gratitude concept and the gratitude-based intervention in the palliative care context, and finally (iv) to explore the sensitivity to change of our selected measures in order to calculate a sample size.
Procedure and measures:
Quantitative data will be collected at baseline (T0) and post-intervention (T1) with validated questionnaires. The intervention will last for one week. Five to ten days after T1, qualitative data will be collected from semi-structured interviews with the participants and from the content of the gratitude letters to explore their representations of the gratitude concept and their perception of the intervention.
The intervention includes the following steps:
- Patients and caregivers recruitment: The clinical team (treating physician or advanced practice nurse) at each recruitment site will identify 10 patient-caregivers dyads. A research collaborator will then be in charge of giving information and get consent
- Data collection at T0: Before the intervention, patients and their caregivers who agreed to participate will meet the research collaborator to fill quantitative questionnaires.
- Intervention - 1-week duration: The intervention will be proposed to both the patient and the caregiver and consists of two steps: the "gratitude letter" and the "gratitude visit". In the "gratitude letter", the participant (at least one of the patient or the caregiver) writes about his feelings of gratitude through a letter, based on a written instruction. The "gratitude visit" consists of an extension of the gratitude letter where the writer of the letter (i) either personally reads the letter to the beneficent or (ii) gives it to him and asks him to read it in his presence or later in his absence.
- Data collection at T1: 5 to 10 days after the intervention itself, the patient and the caregiver, will meet with the research collaborator again to participate to a second quantitative assessment, similar to T0.
- Qualitative assessment: 5 to 15 days after T1: This part is facultative. During the qualitative interviews, the following topics will be explored: their meanings of the term "gratitude"; experiences of gratitude; their experience of the intervention itself; obstacles and facilitators of the intervention; the impact of the intervention for themselves and for their relationship.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical trial has a single arm: all the dyads will go through all the steps (apart from the qualitative assessment which are facultatives).
| Arm | Type | Receives |
|---|---|---|
| Gratitude intervention | Experimental | Behavioral: Gratitude interventionThe intervention will be proposed to both the patient and the caregiver and consists of two steps: the "gratitude letter" and the "gratitude visit". In the "gratitude letter", the individual writes about his feelings of gratitude through a letter, based on a written instruction. The "gratitude visit" consists of an extension of the gratitude letter where the writer of the letter (i) either personally reads the letter to the beneficent or (ii) gives it to him and asks him to read it in his presence or later in his absence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Gratitude interventionAlso: gratitude letter, gratitude visitThe intervention will be proposed to both the patient and the caregiver and consists of two steps: the "gratitude letter" and the "gratitude visit". In the "gratitude letter", the individual writes about his feelings of gratitude through a letter, based on a written instruction. The "gratitude visit" consists of an extension of the gratitude letter where the writer of the letter (i) either personally reads the letter to the beneficent or (ii) gives it to him and asks him to read it in his presence or later in his absence. | Behavioural | Gratitude intervention |
Primary outcome
Change in relationship quality for patients and caregivers
Time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
The quality of the relationship between the palliative patient and his/her caregiver will be measured with the Couple Satisfaction Index (CSI-4; "total score" range from 0 to 21, higher scores indicating a better quality of relationship).
Change in relationship quality for patients and caregivers
Time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
The quality of the relationship between the palliative patient and his/her caregiver will be also measured with the Positive Negative Relationship Quality Scale (PNRQ; "positive subscale" range from 0 to 48 and "negative subscale" range from 0 to 48, with higher scores indicating higher quality of relationship).
6 secondary outcomes
Change in subjective quality of life for patients
Time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in subjective quality of life for caregivers
Time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in psychological distress for patients
Time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in psychological distress for caregivers
Time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in burden for patients
Time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
Change in burden for caregivers
Time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
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 19 Dec 2020.
- Individual participant dataSharing planned: Undecided. Undecided up to now
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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.
Mathieu Bernard principal investigator
Palliative and Supportive care service of the Centre Hospitalier Universitaire Vaudois
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude intervention in people with Palliative Care, run by Centre Hospitalier Universitaire Vaudois at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in relationship quality for patients and caregivers (time frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2020.