Condition category
Cancer
Date applied
04/05/2016
Date assigned
13/05/2016
Last edited
08/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Editorial Notes

08/11/2016: Publication reference added. 25/05/2016: Uploaded participant information sheet.