Clinical trial NCT04254926: Impact of a Resource-based Life Review Intervention on Advanced Cancer Patients
Official title: " Revie ⊕" Impact of a Resource-based Life Review Intervention on Patients With Advanced Cancer in an Outpatient Oncology Center: a Waitlist Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: resource-based
self-esteem
life review intervention
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
Collaborators: name: Krebsforschung Schweiz, Bern, Switzerland
name: University Hospital, Geneva
First posted: 2020-02-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Self-esteem
timeFrame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months
Secondary outcomes:
measure: Spiritual well-being
timeFrame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months
measure: Personal development
timeFrame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months
measure: Satisfaction with life
timeFrame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months
measure: The patient's perception of their interaction with the nurse
timeFrame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Genève
city: Geneva
country: Switzerland
facility: Haute école de santé
Study officials:
affiliation: University Hospital, Geneva
name: Sophie Pautex, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.