Effect of Gender on Distress and Fatigue in Cancer Patients

Sponsor
Ente Ospedaliero Ospedali Galliera (Other)
Overall Status
Recruiting
CT.gov ID
NCT05122052
Collaborator
(none)
500
Enrollment
1
Location
47.1
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Distress in cancer patients has been shown to be higher in females than males, but the behavior of distress during time in longitudinal prospective studies has not been studied, nor is it known if there are differences related to gender during time. These differences may have important therapeutic implications in terms of selective psychological support as cancer progresses during individual trajectories.

The aim of the present study is to examine the effect of gender during time on psychological distress and fatigue in cancer patients across a broad range of cancer types. It is hypothesized that women will report higher psychological distress than men at initial visit but a reversed trend will be observed during follow-up as a result of different coping capabilities between men and women.

Patients attending a cancer outpatient clinic are invited to undergo a psychological session immediately before the medical visit. Distress is assessed by the Distress thermometer and fatigue by the ESAS-r scale at the end of the session. Patients will undergo follow-up visits to assess changes during time and possible time by gender interactions.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Psychological session

Detailed Description

Distress and fatigue in cancer patients are important factors affecting treatment compliance and efficacy and quality of life. The prevalence of moderate or severe emotional distress in cancer patients ranges from 30 to 45% depending on a point of assessment. The National Comprehensive Cancer Network indicates that all cancer patients should undergo a distress measurement as the sixth vital parameter to prevent more serious psychological disorders, including anxiety, depression and coping disturbances. Several studies indicate that patients undergoing psychotherapy or psychosocial support to relieve cancer distress have better disease coping, a reduction of fatigue, anxiety and depression and an improvement in quality of live and possibly survival.

Distress in cancer patients has been shown to be higher in females than males, but the behavior of distress during time in longitudinal prospective studies has not been studied, nor is it known if there are differences related to gender during time. These differences may have important therapeutic implications in terms of selective psychological support as cancer progresses during individual trajectories.

The aim of the present study is to examine the effect of gender during time on psychological distress and fatigue in cancer patients across a broad range of cancer types. It is hypothesized that women will report higher psychological distress than men at initial visit but a reversed trend will be observed during follow-up as a result of different coping capabilities between men and women.

Patients attending a cancer outpatient clinic are invited to undergo a psychological session immediately before the medical visit. Distress is assessed by the Distress thermometer and fatigue by the ESAS-r scale at the end of the session. Patients will undergo follow-up visits to assess changes during time and possible time by gender interactions.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Gender on Distress and Fatigue Over Time in Cancer Patients. A Prospective Longitudinal Study.
Actual Study Start Date :
Nov 28, 2018
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Women with cancer

Patients with cancer of any site and stage defined as feminine both from the biological (female sex) and psychosocial point of view (feminine gender)

Other: Psychological session
Just before the oncology visit, each patient is invited to undergo a psychological session of 20-30 minutes. During the session with a psycho-oncologist the following tasks are addressed: 1) favor emotional expression identifying the most difficult issues to promote mechanisms of elaboration of living experiences; 2) offer a containment of intense emotions; 3) assess awareness of diagnosis and prognosis; 4) favor expression of fears of treatment expectancy; 5) favor expression of difficulties on the inability to cope with prior commitments after the disease; 6) assess family and friend network; 7) improve the patient medic communication and relationship. At the end of the session, the distress thermometer and ESAS-r scale are compiled together with the demographic characteristics. All outstanding issues that are relevant to the therapeutic plan are then discussed between the psychotherapist and the medic before the oncology visit together with delivery of the DT and ESASr scale result.

Men with cancer

Patients with cancer of any site and stage defined as masculine both from the biological (male sex) and psychosocial point of view (masculine gender)

Other: Psychological session
Just before the oncology visit, each patient is invited to undergo a psychological session of 20-30 minutes. During the session with a psycho-oncologist the following tasks are addressed: 1) favor emotional expression identifying the most difficult issues to promote mechanisms of elaboration of living experiences; 2) offer a containment of intense emotions; 3) assess awareness of diagnosis and prognosis; 4) favor expression of fears of treatment expectancy; 5) favor expression of difficulties on the inability to cope with prior commitments after the disease; 6) assess family and friend network; 7) improve the patient medic communication and relationship. At the end of the session, the distress thermometer and ESAS-r scale are compiled together with the demographic characteristics. All outstanding issues that are relevant to the therapeutic plan are then discussed between the psychotherapist and the medic before the oncology visit together with delivery of the DT and ESASr scale result.

Outcome Measures

Primary Outcome Measures

  1. Cancer distress [3 years]

    The patient rates his/her level of distress over the past week after the psychological session. The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a single-item tool using a 0 (no distress) to 10 (extreme distress)-point Likert scale resembling a thermometer. Additionally, the patient is prompted to identify sources of distress using a 39-item supplemental list of potential sources of distress, including the following domains: emotional, physical, practical, family, and spiritual/religious problems. DT scores are categorized in three levels, 0-3, low, 4-6, moderate, 7-10, severe. The DT has demonstrated adequate reliability and has been translated and validated into numerous languages, including Italian.

Secondary Outcome Measures

  1. Cancer fatigue [3 years]

    The Edmonton Symptom Assessment System (ESAS) represents one of the first symptom batteries in palliative care to support symptom assessment in many centers worldwide. A revised ESAS numeric rating scale (ESAS-r) consisting of 9 core symptoms (pain, tiredness, nausea, depression, anxious, drowsiness, appetite, feeling of well being, shortness of breath) and an optional 10th symptom has more recently been developed. Specifically, ESAS-r stated the time frame of symptom assessment as "now", added brief explanations for tiredness ("lack of energy"), drowsiness ("feeling sleepy"), depression ("feeling sad") and anxiety ("feeling nervous") and well-being ("how you feel overall"), changed "appetite" to "lack of appetite", adjusted the order of symptoms, removed the horizontal line over the numbers and shaded alternate items in gray for readability, and sugge

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with cancer of any site and stage willing to undergo a psychological interview before the medical visit.
Exclusion Criteria:
  • None

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1E.O. Ospedali GallieraGenovaItaly16128

Sponsors and Collaborators

  • Ente Ospedaliero Ospedali Galliera

Investigators

  • Study Chair: Gabriella Rondanina, PhD, Ente Ospedaliero Ospedali Galliera

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Andrea DeCensi, Director of Medical Oncology, Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier:
NCT05122052
Other Study ID Numbers:
  • 028/2019
First Posted:
Nov 16, 2021
Last Update Posted:
Dec 3, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andrea DeCensi, Director of Medical Oncology, Ente Ospedaliero Ospedali Galliera
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021