Breast CancerNCT00536055
Dyadic Coping in Breast and Prostate Cancer Patients and Their Spouses
An observational study of Breast Cancer and Prostate Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Dyadic Coping
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyadic pairs (not necessarily married, but in couples)
- One member of the couple has breast cancer or prostate cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- To assess the level of post traumatic distress, functional impairment and depression among breast and prostate cancer patients and their spouses.
- To assess resiliency factors such as flexibility, self efficacy and ego resilience among breast and prostate cancer patients and their spouses.
- 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.
- 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.
Read the 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, 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.
Measures:
- Demographic and medical questionnaire (adapted to the type of illness).
- 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).
- 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).
- Depression questionnaire (CESD, The Centre For Epidemiological Studies Depression Scale (CES-D).
- Flexibility Questionnaire: The Flexibility Scale was developed by Bonanno and Pat-Horenczyk in (2006) and translated into Hebrew.
- 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.
- 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.
- 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.
- Conditions
- Breast Cancer, Prostate Cancer, Dyadic Coping
- Keywords
- breast cancer, prostate cancer, dyadic coping
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startOct 2007
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Herzog Hospital
- Investigators
- Benjamin W Corn, M.D., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536055
- Sponsor's protocol ID
- TASMC - 07 - BC-07309
- Status last verified
- Sep 2007
- First submitted
- 26 Sep 2007
- Last updated
- 27 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Coping in Breast and Prostate Cancer Patients and Their Spouses - A Pilot Stdy
- ClinicalTrials.gov ID
- NCT00536055
- Acronym / sponsor ID
- TASMC - 07 - BC-07309
- Conditions
- Breast Cancer, Prostate Cancer, Dyadic Coping
- Keywords
- breast cancer, prostate cancer, dyadic coping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Herzog Hospital
- Study start
- Oct 2007
- Study completion
- Aug 2008 (estimated)
- First posted
- 27 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the level of post traumatic distress, functional impairment and depression among breast and prostate cancer patients and their spouses.
- To assess resiliency factors such as flexibility, self efficacy and ego resilience among breast and prostate cancer patients and their spouses.
- 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.
- 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, 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.
Measures:
- Demographic and medical questionnaire (adapted to the type of illness).
- 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).
- 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).
- Depression questionnaire (CESD, The Centre For Epidemiological Studies Depression Scale (CES-D).
- Flexibility Questionnaire: The Flexibility Scale was developed by Bonanno and Pat-Horenczyk in (2006) and translated into Hebrew.
- 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.
- 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.
- 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 design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dyadic pairs (not necessarily married, but in couples)
- One member of the couple has breast cancer or prostate cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin W Corn, M.D. principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin W Corn, M.D. (03-6947285, bencorn@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2007.