Impact of a Resource-based Life Review Intervention on Advanced Cancer Patients (Revie⊕)

June 7, 2023 updated by: Gora Da Rocha, School of Health Sciences Geneva

" Revie ⊕" Impact of a Resource-based Life Review Intervention on Patients With Advanced Cancer in an Outpatient Oncology Center: a Waitlist Randomized Controlled Trial

The main objective of the present study is to evaluate the effects of the Revie ⊕ intervention on the self-esteem of patients diagnosed with an advanced cancer. A pragmatic, two-arm parallel-group, waitlist randomized controlled trial is conducted. The study takes place in the oncology department of the University Hospitals of Geneva at 3 outpatient units.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of the present study is to evaluate the effects of the Revie ⊕ intervention on the self-esteem of patients diagnosed with an advanced cancer. The secondary objectives are to evaluate the effects of the Revie ⊕ intervention on spiritual well-being, personal development, life satisfaction, and the perception of the interaction with the nurses. A pragmatic, two-arm parallel-group, waitlist randomized controlled trial (WLRCT) is conducted in which participants are randomized into (i) intervention, or (ii) waitlist control groups. The intervention group (IG) receives the Revie ⊕ intervention early on and the control group (CG) the same intervention but later on (i.e., after eight weeks).This monocentric study takes place in the oncology department of the University Hospitals of Geneva (HUG) at two outpatient units (planned n=102; 51 per group).

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • 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
      • Geneva, Switzerland, 1200
        • Hôpitaux Universitaires de Genève
      • Geneva, Switzerland, 1206
        • Haute Ecole de Santé

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18 years with and advanced cancer,
  • whose general health status is adequate for participation in the study based on a clinical assessment by the nurse / doctor; and
  • who consent to participate in the study.

Exclusion Criteria:

  • documented cognitive impairment that compromises capacity for discernment,
  • command of French is insufficient for reading, writing, or conversing.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Revie ⊕ intervention early
participants randomized into (i) the intervention group (IG) receive the Revie ⊕ intervention early on.
Behavioral: Revie ⊕
Revie ⊕ is a positive approach centered on the resources and strengths of the patient, and it consists of an intervention that focuses on the individual's life review. Revie ⊕ allows specialist nurses to discuss life events with cancer patients, to identify the significant elements, and to explore how the diagnosis has changed their values and preferences. The intervention is geared toward working with the patient to discover their potential, to identify their strategies for coping with the events of their life, and to thereby accompany them in achieving a better understanding of themselves and what defines their identity. The intervention also allows their concerns surrounding death to be addressed, in addition to providing clarity in regard to the life projects. In the end, as a conclusion to the intervention, the patient is provided a booklet recounting the salient features of their life review along with photographs, quotes, or images.
Experimental: Revie ⊕ intervention later
The control group (CG) receives the same intervention Revie ⊕ but later on (i.e., after eight weeks).
Behavioral: Revie ⊕
Revie ⊕ is a positive approach centered on the resources and strengths of the patient, and it consists of an intervention that focuses on the individual's life review. Revie ⊕ allows specialist nurses to discuss life events with cancer patients, to identify the significant elements, and to explore how the diagnosis has changed their values and preferences. The intervention is geared toward working with the patient to discover their potential, to identify their strategies for coping with the events of their life, and to thereby accompany them in achieving a better understanding of themselves and what defines their identity. The intervention also allows their concerns surrounding death to be addressed, in addition to providing clarity in regard to the life projects. In the end, as a conclusion to the intervention, the patient is provided a booklet recounting the salient features of their life review along with photographs, quotes, or images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-esteem
Time Frame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months

Self-esteem will be measured by the Rosenberg Self-Esteem Scale (RSE, 10 items) developed in 1965 (French version).

Minimum value = 1 Maximum value = 4. A score above 30 points corresponds to a high level of self-esteem, between 20 and 30 points indicates a moderate self-esteem, and a score of less than 20 points reflects a low self-esteem.
Baseline, change from Baseline at 2 months, change from Baseline at 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spiritual well-being
Time Frame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months

Spiritual well-being will be measured by the Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp).

Minimum value = 0 Maximum value = 4. The higher the score, the better the spiritual well-being.
Baseline, change from Baseline at 2 months, change from Baseline at 4 months
Personal development
Time Frame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months
Personal development will be measured by the Post-Traumatic Growth Inventory (PTGI) instrument developed by Tedeschi and Calhoun in 1996 Minimum value = 1 Maximum value = 6. A high score means a high level of development.
Baseline, change from Baseline at 2 months, change from Baseline at 4 months
Satisfaction with life
Time Frame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months

Satisfaction with life will be measured with the Satisfaction With Life Scale (SWLS) instrument developed by Pavot and Diener in 1985.

Minimum value = 1 Maximum value = 7. A high score means a high level of satisfaction with life.
Baseline, change from Baseline at 2 months, change from Baseline at 4 months
The patient's perception of their interaction with the nurse
Time Frame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months
The Nurse-Patient-Interaction Scale (NPIS) questionnaire developed by Haugan in 2012 will be used to evaluate the patient's perception of their interaction with the nurse Minimum value = 1 Maximum value = 10. A high score means a great appreciation of interaction.
Baseline, change from Baseline at 2 months, change from Baseline at 4 months

Collaborators and Investigators

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

Sponsor

School of Health Sciences Geneva

Collaborators

University Hospital, Geneva
Krebsforschung Schweiz, Bern, Switzerland

Investigators

  • Principal Investigator: Sophie Pautex, Professor, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 6, 2019

Primary Completion (Actual)

August 18, 2021

Study Completion (Actual)

August 18, 2021

Study Registration Dates

First Submitted

December 14, 2019

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFS-4390-02-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

this has to be specified later

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.

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