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Advanced CancerRevie⊕NCT04254926

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

A study testing Revie ⊕ in people with Advanced Cancer, run by School of Health Sciences Geneva at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Revie ⊕
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
2 sitesSwitzerland
Study dates
6 Apr 2019to 18 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Hopitaux Universitaires de Genève

    Geneva, 1200

  • Haute école de santé

    Geneva, 1206

Other trials in Switzerland

About this study

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

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.

Read the 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).

Conditions
Advanced Cancer
Being tested
Revie ⊕
Keywords
resource-based, self-esteem, life review intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Revie ⊕Behavioural

    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.

Study groups in NCT04254926
Study groupRoleWhat they receive
Revie ⊕ intervention earlyExperimentalparticipants randomized into (i) the intervention group (IG) receive the Revie ⊕ intervention early on.
Receives: Behavioral: Revie ⊕
Revie ⊕ intervention laterExperimentalThe control group (CG) receives the same intervention Revie ⊕ but later on (i.e., after eight weeks).
Receives: Behavioral: Revie ⊕

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Spiritual well-being

    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.

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

  2. Personal development

    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.

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

  3. Satisfaction with life

    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.

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

  4. The patient's perception of their interaction with the nurse

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start6 Apr 2019
  3. Primary completion18 Aug 2021
  4. Study completion18 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04254926
Sponsor's protocol ID
KFS-4390-02-2018
Acronym
Revie⊕
Status last verified
Jun 2023
First submitted
14 Dec 2019
Last updated
8 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: this has to be specified later

Publications

  • 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.

    PubMed 30850142

  • 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.

    PubMed 28186482

  • 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.

    PubMed 27965878

  • 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.

    PubMed 38301385

Questions about this trial

What is this clinical trial studying?

A study testing Revie ⊕ in people with Advanced Cancer, run by School of Health Sciences Geneva at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-esteem (time frame: Baseline, change from Baseline at 2 months, change from Baseline at 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04254926, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.

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