Effect of Gender on Distress and Fatigue in Cancer Patients
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | E.O. Ospedali Galliera | Genova | Italy | 16128 |
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
- 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.
- Bultz BD, Carlson LE. Emotional distress: the sixth vital sign--future directions in cancer care. Psychooncology. 2006 Feb;15(2):93-5.
- Faller H, Weis J, Koch U, Brähler E, Härter 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.
- 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. Epub 2005 Jun 4.
- 028/2019