Impact of a Gratitude-based Intervention in Palliative Care (IPBG) (IPBG)

December 17, 2020 updated by: Mathieu BERNARD, Centre Hospitalier Universitaire Vaudois

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 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
  2. Data collection at T0: Before the intervention, patients and their caregivers who agreed to participate will meet the research collaborator to fill quantitative questionnaires.
  3. 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.
  4. 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.
  5. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Fribourg, Switzerland, 1708
        • Fribourg University hospital, Unité et Accueil de jour de soins palliatifs
    • Vaud
      • Blonay, Vaud, Switzerland, 1807
        • Rive-Neuve Foundation
      • Lausanne, Vaud, Switzerland, 1011
        • Lausanne University hospital, Palliative and supportive care service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Gratitude intervention
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.
Behavioral: Gratitude intervention
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.
Other Names:
  • gratitude letter
  • gratitude visit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
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).
Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in subjective quality of life for patients
Time Frame: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
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)
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
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)
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
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)
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
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).
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
Burden will be measured with the Self Perceived Burden Scale (SPBS, "total score" range from 10 to 50, with higher scores indicating higher burden).
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
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).
Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Vaudois

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mathieu Bernard, Palliative and Supportive care service of the Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IPBG2018-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided up to now

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Palliative Care

Clinical Trials on Gratitude intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings