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

NCT03703687 | Completed DMC

• 1 other identifier: IPBG2018-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Palliative Care

Keywords

palliative care; gratitude; positive psychology

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention

Secondary Outcomes (6)

• Change in subjective quality of life for patients

  Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention

• Change in subjective quality of life for caregivers

  Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention

• Change in psychological distress for patients

  Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention

• Change in psychological distress for caregivers

  Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention

• Change in burden for patients

  Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention

Study Arms (1)

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.

Behavioral: Gratitude intervention

Interventions

Gratitude intervention BEHAVIORAL

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.

Also known as: gratitude letter, gratitude visit

Gratitude intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).
• Age \>18
• Identified as the caregiver by the palliative patient (see above)
• prior agreement of the patient for the participation of the caregiver
• 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.).

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (3)

Rive-Neuve Foundation

Blonay, Canton of Vaud, 1807, Switzerland

Location

Lausanne University hospital, Palliative and supportive care service

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Fribourg University hospital, Unité et Accueil de jour de soins palliatifs

Fribourg, 1708, Switzerland

Location

Study Officials

• Mathieu Bernard

  Palliative and Supportive care service of the Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Research Unit of the palliative and supportive care service

Model Details: This clinical trial has a single arm: all the dyads will go through all the steps (apart from the qualitative assessment which are facultatives).

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 12, 2018
• Study Start: November 27, 2018
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

CH (3)