Effect of Gender on Distress and Fatigue in Cancer Patients

Cancer Clinical Trial

Official title:

Effect of Gender on Distress and Fatigue Over Time in Cancer Patients. A Prospective Longitudinal Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122052
• Other study ID #: 028/2019
• Status: Recruiting
• Start date: November 28, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: Gabriella Rondanina, PhD
• Phone: +393356668299
• Email: gabriella.rondanina[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 31, 2025
• Est. primary completion date: September 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Fatigue

Intervention

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.

Locations

Country	Name	City	State
Italy	E.O. Ospedali Galliera	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Ospedali Galliera

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2022 Nov 7. doi: 10.1007/s11764-022-01291-z. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cancer fatigue	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	3 years