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NCT Number: NCT04254926

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

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haute école de santé, Geneva, Switzerland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

School of Health Sciences Geneva

Other

Collaborators

  • Krebsforschung Schweiz, Bern, Switzerland
  • University Hospital, Geneva

Registry information

Official study 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

Acronym: Revie⊕

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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