Clinical trial · Observational
Effect of Gender on Distress and Fatigue in Cancer Patients
Effect of Gender on Distress and Fatigue Over Time in Cancer Patients. A Prospective Longitudinal Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychological session | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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)
- interventionNames
- Other: Psychological session
- label
- 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)
- interventionNames
- Other: Psychological session
Primary outcomes (1)
- measure
- Cancer distress
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDBultz 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
- BACKGROUNDMoro 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
- BACKGROUNDFaller 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
- BACKGROUNDBoyes 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
- BACKGROUNDRondanina 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