Ignite Creation Date:
2024-05-05 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00536055
Status:
UNKNOWN
Last Update Posted:
2007-09-27
First Post:
2007-09-26
Brief Title:
Dyadic Coping in Breast and Prostate Cancer Patients and Their Spouses
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Dyadic Coping in Breast and Prostate Cancer Patients and Their Spouses - A Pilot Stdy
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to focus on dyadic coping as one of the main factors that enhance resilience in adjustment to cancer while also assessing other protective factors for coping with traumatic events
Specifically the study aims are
1 To assess the level of post traumatic distress functional impairment and depression among breast and prostate cancer patients and their spouses
2 To assess resiliency factors such as flexibility self efficacy and ego resilience among breast and prostate cancer patients and their spouses
3 To examine the pattern of dyadic coping at 3 time points at the beginning and end of radiation therapy and at six-week follow-up
4 To examine the relationships between dyadic coping and level of posttraumatic distress and the resilience factors over time in 3 repeated measures Different aspects of coping with the trauma of cancer and its treatment may be assessed Measures of strength and distress amongst patients and their spouses may enable a fuller picture of what types of responses exist which interventions may be most beneficial and what other factors may relate to positive coping increased resilience and quality of life such as flexibility and the nature of the couples dyadic coping
Specifically the study aims are
1 To assess the level of post traumatic distress functional impairment and depression among breast and prostate cancer patients and their spouses
2 To assess resiliency factors such as flexibility self efficacy and ego resilience among breast and prostate cancer patients and their spouses
3 To examine the pattern of dyadic coping at 3 time points at the beginning and end of radiation therapy and at six-week follow-up
4 To examine the relationships between dyadic coping and level of posttraumatic distress and the resilience factors over time in 3 repeated measures Different aspects of coping with the trauma of cancer and its treatment may be assessed Measures of strength and distress amongst patients and their spouses may enable a fuller picture of what types of responses exist which interventions may be most beneficial and what other factors may relate to positive coping increased resilience and quality of life such as flexibility and the nature of the couples dyadic coping
Detailed Description:
Introduction
In the proposed study we will investigate the risk and protective factors for healthy coping amongst breast and prostrate cancer patients and their spouses A special focus will be on dyadic coping patterns ie how do the coping patterns of the patient and hisher spouse correlate and how does the spousal response facilitate or impede the outcome of coping of the patient
Different aspects of coping with the trauma of cancer and its treatment may be assessed Measures of strength and distress amongst patients and their spouses may enable a fuller picture of what types of responses exist which interventions may be most beneficial and what other factors may relate to positive coping increased resilience and quality of life such as flexibility and the nature of the couples dyadic coping
All new incoming married patients to the Institute of Radiotherapy at the Tel Aviv Sourasky Medical Center from September to January 2007 will be presented with the request to participate in this research Overall we plan to recruit 40 breast and prostate cancer patients and their spouses
Measures
1 Demographic and medical questionnaire adapted to the type of illness
2 Exposure to trauma Participants exposure to possible traumatic events was assessed by The Trauma History Scale created by Pat-Horenczyk in 2004 based on the Posttraumatic Diagnostic Scale PDS by Foa Cashman Jaycox and Perry 1997
3 Posttraumatic Stress Diagnostic Scale PDS A self-report assessment that meets all the criteria of the DSM-IV for diagnosis of PTSD developed by Foa Cashman Jaycox Perry 1997
4 Depression questionnaire CESD The Centre For Epidemiological Studies Depression Scale CES-D
5 Flexibility Questionnaire The Flexibility Scale was developed by Bonanno and Pat-Horenczyk in 2006 and translated into Hebrew
6 Dyadic coping The quality of adjustment in the marital relationship will be measured using the Dyadic Adjustment Scale DAS This 32 item measure is widely used in clinical and research settings and consists of four subscales Dyadic Consensus Dyadic Satisfaction Dyadic Cohesion and Affectional Expression
7 Self efficacy The GSE General perceived self efficacy scale was developed by Zeidner Jerusalem Schwarzer 1993 and includes 10 items which measure positive self statements with regards to a variety of coping requirements
8 Ego Resilience The short 14 item version of Ego-Resiliency Scale was presented in 1996 by Block Kremen 1996
Procedure
Physicians working at the Institute of Radiotherapy at the Tel Aviv Sourasky Medical Center will inform all potential participants about the purpose of the study Those who show interest and match the inclusion criteria will be asked to sign the informed consent with the doctor who will provide more detailed information The research assistant will set up a meeting at the Medical Center with the each interested couple individually with each couple to fill out the questionnaires The approximate time for filling out the entire battery is 30 minutes In order to participate both patients and their spouses must agree to fill out the questionnaires at the three time points
In the informed consent it will be specified that participants who may experience distress following the questionnaire or as a result of the research will be offered short individual or couple counseling as needed by the psychosocial staff of the Institute of Radiotherapy
In the proposed study we will investigate the risk and protective factors for healthy coping amongst breast and prostrate cancer patients and their spouses A special focus will be on dyadic coping patterns ie how do the coping patterns of the patient and hisher spouse correlate and how does the spousal response facilitate or impede the outcome of coping of the patient
Different aspects of coping with the trauma of cancer and its treatment may be assessed Measures of strength and distress amongst patients and their spouses may enable a fuller picture of what types of responses exist which interventions may be most beneficial and what other factors may relate to positive coping increased resilience and quality of life such as flexibility and the nature of the couples dyadic coping
All new incoming married patients to the Institute of Radiotherapy at the Tel Aviv Sourasky Medical Center from September to January 2007 will be presented with the request to participate in this research Overall we plan to recruit 40 breast and prostate cancer patients and their spouses
Measures
1 Demographic and medical questionnaire adapted to the type of illness
2 Exposure to trauma Participants exposure to possible traumatic events was assessed by The Trauma History Scale created by Pat-Horenczyk in 2004 based on the Posttraumatic Diagnostic Scale PDS by Foa Cashman Jaycox and Perry 1997
3 Posttraumatic Stress Diagnostic Scale PDS A self-report assessment that meets all the criteria of the DSM-IV for diagnosis of PTSD developed by Foa Cashman Jaycox Perry 1997
4 Depression questionnaire CESD The Centre For Epidemiological Studies Depression Scale CES-D
5 Flexibility Questionnaire The Flexibility Scale was developed by Bonanno and Pat-Horenczyk in 2006 and translated into Hebrew
6 Dyadic coping The quality of adjustment in the marital relationship will be measured using the Dyadic Adjustment Scale DAS This 32 item measure is widely used in clinical and research settings and consists of four subscales Dyadic Consensus Dyadic Satisfaction Dyadic Cohesion and Affectional Expression
7 Self efficacy The GSE General perceived self efficacy scale was developed by Zeidner Jerusalem Schwarzer 1993 and includes 10 items which measure positive self statements with regards to a variety of coping requirements
8 Ego Resilience The short 14 item version of Ego-Resiliency Scale was presented in 1996 by Block Kremen 1996
Procedure
Physicians working at the Institute of Radiotherapy at the Tel Aviv Sourasky Medical Center will inform all potential participants about the purpose of the study Those who show interest and match the inclusion criteria will be asked to sign the informed consent with the doctor who will provide more detailed information The research assistant will set up a meeting at the Medical Center with the each interested couple individually with each couple to fill out the questionnaires The approximate time for filling out the entire battery is 30 minutes In order to participate both patients and their spouses must agree to fill out the questionnaires at the three time points
In the informed consent it will be specified that participants who may experience distress following the questionnaire or as a result of the research will be offered short individual or couple counseling as needed by the psychosocial staff of the Institute of Radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None