Dyadic Coping in Breast and Prostate Cancer Patients and Their Spouses
Recruitment status was: Not yet recruiting
|First Received Date ICMJE||September 26, 2007|
|Last Updated Date||September 26, 2007|
|Start Date ICMJE||October 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Dyadic Coping in Breast and Prostate Cancer Patients and Their Spouses|
|Official Title ICMJE||Dyadic Coping in Breast and Prostate Cancer Patients and Their Spouses - A Pilot Stdy|
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:
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, i.e. how do the coping patterns of the patient and his/her 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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||40|
|Estimated Completion Date||August 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00536055|
|Other Study ID Numbers ICMJE||TASMC - 07 - BC-07309|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Tel-Aviv Sourasky Medical Center|
|Collaborators ICMJE||Herzog Hospital|
|PRS Account||Tel-Aviv Sourasky Medical Center|
|Verification Date||September 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP