Impact of a Resource-based Life Review Intervention on Advanced Cancer Patients

NCT ID: NCT04254926

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-06

Study Completion Date

2021-08-18

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Revie ⊕ intervention early

participants randomized into (i) the intervention group (IG) receive the Revie ⊕ intervention early on.

Group Type EXPERIMENTAL

Revie ⊕

Intervention Type BEHAVIORAL

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.

Revie ⊕ intervention later

The control group (CG) receives the same intervention Revie ⊕ but later on (i.e., after eight weeks).

Group Type EXPERIMENTAL

Revie ⊕

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krebsforschung Schweiz, Bern, Switzerland

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

School of Health Sciences Geneva

OTHER

Sponsor Role lead

Responsible Party

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Gora Da Rocha

Professor assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sophie Pautex, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Hopitaux Universitaires de Genève

Geneva, , Switzerland

Site Status

Haute école de santé

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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da Rocha Rodrigues MG, Pautex S, Zumstein-Shaha M. Revie plus sign in circle: An intervention promoting the dignity of individuals with advanced cancer: A feasibility study. Eur J Oncol Nurs. 2019 Apr;39:81-89. doi: 10.1016/j.ejon.2019.01.006. Epub 2019 Jan 30.

Reference Type BACKGROUND
PMID: 30850142 (View on PubMed)

Da Rocha Rodrigues MG, Colin S, Shaha M, Pautex S. [The acceptability of the intervention Revie plus sign in circle : the nurses' perceptions and experiences]. Rech Soins Infirm. 2016 Dec;(127):55-70. doi: 10.3917/rsi.127.0055. French.

Reference Type BACKGROUND
PMID: 28186482 (View on PubMed)

Da Rocha Rodrigues MG, Pautex S, Shaha M. Revie plus sign in circle: 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. Pilot Feasibility Stud. 2016 Oct 19;2:63. doi: 10.1186/s40814-016-0101-z. eCollection 2016.

Reference Type BACKGROUND
PMID: 27965878 (View on PubMed)

Da Rocha Rodrigues G, Warne DW, Scuderi L, Lilla D, Stanic J, Pautex S. Revie plus sign in circle: Impact of a resource-based life review intervention on patients with advanced cancer: A waitlist controlled trial. Eur J Oncol Nurs. 2024 Feb;68:102506. doi: 10.1016/j.ejon.2024.102506. Epub 2024 Jan 6.

Reference Type DERIVED
PMID: 38301385 (View on PubMed)

Other Identifiers

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KFS-4390-02-2018

Identifier Type: -

Identifier Source: org_study_id

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