Plain English Summary
Background and study aims
A new life review intervention (programme) "Revie ⊕" for adults with advanced cancer has been developed. It consists of sharing significant events about a person's life history and supporting personal development by focusing on positive changes that have occurred since being diagnosed with cancer. Based on this information, a booklet is created, in which photos, poems, or another important text can be included. Once completed, the booklets are given to the participants. The focus of the intervention is to help patients approach the end-of-life in a more positive and dignified way. It can contribute to personal development and a better overall level of satisfaction with life. This study aims to evaluate the feasibility of Revie ⊕ .
Who can participate?
Adults (aged 18 or older) with advanced cancer.
What does the study involve?
The intervention involves a patient having two sessions with a nurse. In the first session (which takes one hour) the patient is asked to share significant events in their life, discuss their concerns about death and dying, their vision of life and their relationships and focus on positive changes that have occurred since the cancer diagnosis. Drawing on this information, a booklet is created. In the second session (15-30 minutes), this booklet is presented, completed, and finalized. Patients can include photos, poems, or another text that they deem important. Once completed, the booklets are given to the participants.
What are possible benefits and risks for participating?
Patients may benefit from the intervention by promoting dignity, increasing their personal development an overall life satisfaction. The risk of adverse events during the intervention is estimated to be low. Nevertheless if a distress is perceived, the person can benefit from a consultation by a psychologist.
Where is the study run from?
Geneva University Hospital (Switzerland)
When is the study starting and how long is it expected to run?
August 2013 to January 2017
Who is funding the study?
HES-SO University of Applied Sciences and Arts Western Switzerland, School of Health Sciences, Geneva (Switzerland)
Who is the main contact?
Maria Goreti da Rocha Rodrigues
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Maria Goreti da Rocha Rodrigues
ORCID ID
http://orcid.org/0000-0001-7136-8345
Contact details
47 Avenue de Champel
Geneva
1206
Switzerland
Type
Scientific
Additional contact
Dr Maya Shaha
ORCID ID
Contact details
Rue de la Corniche 10
Lausanne
1010
Switzerland
Type
Scientific
Additional contact
Dr Sophie Pautex
ORCID ID
Contact details
4
rue Gabrielle-Perret-Gentil
Geneva
1211
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15-037
Study information
Scientific title
Revie ⊕: the influence of a life review intervention including a positive, patient-centered approach towards enhancing the personal dignity of patients with advanced cancer. A study protocol for a feasibility study using a mixed method investigation
Acronym
Revie ⊕
Study hypothesis
To evaluate the feasibility and preliminary efficacy of a novel intervention, Revie ⊕, to promote the dignity of patients with advanced cancer
Ethics approval
Swiss Ethics Committees on research involving humans, Geneva, 04/06/2015, ref: 15-037
Study design
Pilot pre-post feasibility study using a mixed method approach, i.e. an embedded concurrent design with both quantitative and qualitative parts.
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
See additional files
Condition
Advanced cancer patients, palliative care
Intervention
Life review intervention using a patient-centered positive approach. The intervention encompasses two sessions between a nurse and a patient. In the first session (60 minutes) the participant is firstly asked to share significant events in his life and secondly personal development is supported by focusing on positive changes that have occurred since the cancer diagnosis. In this first intervention five domains are addressed, namely:
1. Reflecting on the patient's life story and specific significant events;
2. Focusing on the positive changes that have occurred since the disease diagnosis;
3. Patients telling their values and vision of life and their relationship with others;
4. Discussing significant issues,
5. Discussing the patient’s deepest concerns and their thoughts about death and dying.
Drawing on this information, a booklet is created. In the second session (15-30 minutes), this booklet is presented, completed, and finalized. Patients can include photos, poems, or another text that they deem important. Once completed, the booklets are given to the participants.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Number of participants recruited: timepoint: end of recruitment: May 2016
2. Intervention retention rates. timepoint: end of recruitment: May 2016
3. Acceptability of the intervention for patients: semi-directed interview about the process and questionnaire about acceptability (T2 post- intervention)
4. Acceptability for nurses delivering the intervention in terms of fidelity (adherence structured content), resources mobilized, and practice change. Diary , focus group and questionnaire end of recruitment: May 2016
Secondary outcome measures
1. Sense of dignity, with The Patient Dignity Inventory (PDI) questionnaire (T0 baseline + T2 post intervention)
2. Post traumatic growth, with The Post-Traumatic Growth Inventory (PTGI) (T0 baseline + T2 post intervention)
3. Satisfaction with life, with The Satisfaction with Life Scale (SWLS) (T0 baseline + T2 post intervention)
Overall trial start date
31/08/2013
Overall trial end date
30/01/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults (aged 18 years or older) with advanced cancer (T3 or T4, or the presence of metastases)
2. Adequate health status to participate in the study, as determined by clinical consensus between nurses and physicians
3. Able to cognitively understand
4. Consent to inclusion in the study
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
N=40
Participant exclusion criteria
1. Patients diagnosed with cognitive disorders related to memory loss or disturbances of speech that would not allow for a constructive exchange,
2. with insufficient command of the French language to complete the study questionnaires.
Recruitment start date
15/04/2015
Recruitment end date
30/04/2016
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Geneva (Hôpital Universitaire de Genève)
Geneva
122 Genève 14
Switzerland
Sponsor information
Organisation
University Institute of Training and Care Research (IUFRS) (Institut Universitaire de Formation et de Recherche en Soins)
Sponsor details
Biopôle 2
Route de la Corniche 10
Lausanne
1010
Switzerland
+41 21 314 58 15
iufrs@unil.ch
Sponsor type
University/education
Website
https://www.unil.ch/sciences-infirmieres/fr/home/menuinst/iufrs.html
Funders
Funder type
University/education
Funder name
HES-SO University of Applied Sciences and Arts Western Switzerland, School of Health Sciences, Geneva, Switzerland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. March 2016: submitted to be published in the journal Pilot and Feasibility Studies. : “Revie + The influence of a life review intervention including a positive, patient-centered approach towards enhancing the personal dignity of patients with advanced cancer. A study protocol for a feasibility study using a mixed method investigation”
2. September 2016: manuscript on the development of the intervention and link with the theoretical framework
3. November 2016: a manuscript on the results of the study
Intention to publish date
30/11/2016
Participant level data
Stored in repository
Results - basic reporting
Publication summary
2016 protocol in: http://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0101-z
Publication citations
Additional files
- ISRCTN12497093_PIS_French.docx uploaded 25/05/2016