Effect of Gender on Distress and Fatigue in Cancer Patients

NCT05122052 | Completed

• 1 other identifier: 028/2019
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Cancer

Keywords

distress; gender; fatigue; time; effect modification

Outcome Measures

Primary Outcomes (1)

• Cancer distress

  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.

  3 years

Secondary Outcomes (1)

• Cancer fatigue

  3 years

Study Arms (2)

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

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

Interventions

Psychological session OTHER

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; Women with cancer

Eligibility Criteria

• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer of any site and stage willing to undergo a psychological interview before the medical visit.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Ente Ospedaliero Ospedali Galliera: lead

Study Sites (1)

E.O. Ospedali Galliera

Genova, Italy, 16128, Italy

Location

Related Publications (5)

• Bultz BD, Carlson LE. Emotional distress: the sixth vital sign--future directions in cancer care. Psychooncology. 2006 Feb;15(2):93-5. doi: 10.1002/pon.1022. No abstract available.

  PMID: 16444764 BACKGROUND

• Moro C, Brunelli C, Miccinesi G, Fallai M, Morino P, Piazza M, Labianca R, Ripamonti C. Edmonton symptom assessment scale: Italian validation in two palliative care settings. Support Care Cancer. 2006 Jan;14(1):30-7. doi: 10.1007/s00520-005-0834-3. Epub 2005 Jun 4.

  PMID: 15937688 BACKGROUND

• Faller H, Weis J, Koch U, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Boehncke A, Hund B, Reuter K, Richard M, Sehner S, Szalai C, Wittchen HU, Mehnert A. Perceived need for psychosocial support depending on emotional distress and mental comorbidity in men and women with cancer. J Psychosom Res. 2016 Feb;81:24-30. doi: 10.1016/j.jpsychores.2015.12.004. Epub 2015 Dec 15.

  PMID: 26800635 BACKGROUND

• Boyes A, Newell S, Girgis A, McElduff P, Sanson-Fisher R. Does routine assessment and real-time feedback improve cancer patients' psychosocial well-being? Eur J Cancer Care (Engl). 2006 May;15(2):163-71. doi: 10.1111/j.1365-2354.2005.00633.x.

  PMID: 16643264 BACKGROUND

• Rondanina G, Siri G, Marra D, DeCensi A. Effect of sex on psychological distress and fatigue over time in a prospective cohort of cancer survivors. J Cancer Surviv. 2024 Apr;18(2):586-595. doi: 10.1007/s11764-022-01291-z. Epub 2022 Nov 7.

  PMID: 36344904 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Coitus; Fatigue

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriella Rondanina, PhD

  Ente Ospedaliero Ospedali Galliera

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Oncology

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: November 28, 2018
• Primary Completion: September 7, 2024
• Study Completion: March 31, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared 3 months following the publication of the article and they will remain available for 36 months.
• Access Criteria: The investigators who would like to use the data have to prepare a proposal that needs to be approved the Steering committee. The aim of the access to study data needs to be specified in the proposal. Proposals should be sent to the Principal investigator (andrea.decensi@galliera.it). To gain access, data requestors will need to sign a data access agreement.

Locations

IT (1)