ClinicalTrials.Veeva

Menu

Effect of Gender on Distress and Fatigue in Cancer Patients

E

Ente Ospedaliero Ospedali Galliera

Status

Completed

Conditions

Cancer

Treatments

Other: Psychological session

Study type

Observational

Funder types

Other

Identifiers

NCT05122052
028/2019

Details and patient eligibility

About

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. We will also investigate if psychological factors (distress, anxiety and depression) affected antibody response and markers of COVID-19 vaccine activation (C-reactive protein, CRP and D-dimer) after 6 months from initial vaccination.

Caregivers will also be interviewed to measure their burden with the Zarit Burden Interview.

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.

Full 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.

In a subset of patients, we will also investigate if psychological factors (distress, anxiety and depression) affected antibody response and markers of COVID-19 vaccine activation (C-reactive protein, CRP and D-dimer) after 6 months from initial vaccination.

Caregivers will also be interviewed with the Zarit questionnaire, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire The 29-item instrument is included in Zarit et al., 1980. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).

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.

Enrollment

500 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with cancer of any site and stage willing to undergo a psychological interview before the medical visit, including those receiving COVID-19 vaccine.

Exclusion criteria

  • None

Trial design

500 participants in 2 patient groups

Women with cancer
Description:
Patients with cancer of any site and stage defined as feminine both from the biological (female sex) and psychosocial point of view (feminine gender)
Treatment:
Other: Psychological session
Men with cancer
Description:
Patients with cancer of any site and stage defined as masculine both from the biological (male sex) and psychosocial point of view (masculine gender)
Treatment:
Other: Psychological session

Trial contacts and locations

1

Loading...

Central trial contact

Gabriella Rondanina, PhD; Andrea De Censi, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems