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

NCT04254926 | Completed DMC

• 1 other identifier: KFS-4390-02-2018
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

resource-based; self-esteem; life review intervention

Outcome Measures

Primary Outcomes (1)

• Self-esteem

  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 Outcomes (4)

• Spiritual well-being

  Baseline, change from Baseline at 2 months, change from Baseline at 4 months

• Personal development

  Baseline, change from Baseline at 2 months, change from Baseline at 4 months

• 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

  Baseline, change from Baseline at 2 months, change from Baseline at 4 months

Study Arms (2)

Revie ⊕ intervention early

EXPERIMENTAL

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

Behavioral: Revie ⊕

Revie ⊕ intervention later

EXPERIMENTAL

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

Behavioral: Revie ⊕

Interventions

Revie ⊕ 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 early; Revie ⊕ intervention later

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• School of Health Sciences Geneva: lead
• Krebsforschung Schweiz, Bern, Switzerland: collaborator
• University Hospital, Geneva: collaborator

Study Sites (2)

Hopitaux Universitaires de Genève

Geneva, 1200, Switzerland

Location

Haute école de santé

Geneva, 1206, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 30850142 BACKGROUND

• 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.

  PMID: 28186482 BACKGROUND

• 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.

  PMID: 27965878 BACKGROUND

• 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.

  PMID: 38301385 DERIVED

Study Officials

• Sophie Pautex, Professor

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor assistant

Model Details: 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).

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: February 5, 2020
• Study Start: April 6, 2019
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)