Partner-Assisted Emotional Disclosure for GI Cancer
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|ClinicalTrials.gov Identifier: NCT00734513|
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : November 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the GI System-stages II III and IV||Behavioral: Partner-assisted emotional disclosure Behavioral: Cancer Education||Not Applicable|
The diagnosis and treatment of GI cancer is a traumatic and life-altering event. Many patients with GI cancer experience significant emotional distress and disruptions in their social relationships as well as multiple physical symptoms and limitations in physical activities. There is evidence that cancer patients who are able to confide their feelings and concerns about the cancer experience with supportive others, particularly their partners, fare better. patients who are able to discuss cancer openly with their partners report fewer emotional and physical complaints, and higher levels of self-esteem and perceived control. However, there are a number of barriers that often inhibit discussion of cancer-related feelings. The proposed study will examine the effect of a new partner-assisted emotional disclosure (ED) protocol for patients with GI cancer.
In this study, 200 patients diagnosed with GI cancer and their partners will be recruited to participate. The couples will be randomly assigned to one of two conditions: 1) partner-assisted emotional disclosure, or 2) cancer education. Assessment measures will be collected at evaluations conducted before and after treatment and at 8 weeks post treatment. All evaluations will be conducted over the phone. Information will also be collected from the physician and/or the patient's medical record at each of the three evaluations. Audiotapes of the partner-assisted emotional disclosure sessions will be transcribed and 10-minute segments will be randomly selected and analyzed to assess the extent to which patients express emotions and partners verbally reflect the partner's feeling in an empathic manner.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Partner Assisted Emotional Disclosure for GI Cancer|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Partner-assisted Emotional Disclosure
Behavioral: Partner-assisted emotional disclosure
Patients and partners in the partner-assisted emotional disclosure condition will attend four weekly face-to-face sessions with a therapist. The first session will last 75 minutes and will focus on training in skills to facilitate the patient's disclosure. The subsequent 3 sessions will last 45 minutes each. In these sessions, the therapist will briefly review the strategies and provide feedback from the previous session and the patient will spend 30 minutes talking about their cancer-related concerns to the partner.
Other Name: Emotional Disclosure
Active Comparator: 2
Behavioral: Cancer Education
The cancer education protocol consists of four weekly face-to-face sessions for education about living with GI cancer. The cancer education sessions will be delivered to patients and their partners and use a presentation and discussion format. Handouts and discussion sessions will center on the following topics: Orientation to Duke Cancer Care and the treatment team; suggestions for communicating with health care providers; resources for health information, psychosocial support, and financial concerns; evaluating health information on the internet; the impact of cancer on different domains of quality of life; and suggestions for maintaining quality of life.
Other Name: Education
- Patient's psychological adjustment [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ]
- Patient's physical and functional well-being [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ]
- Communication quality between the patient and partner (i.e.level of disclosure, helpfulness of disclosure, and perceived empathy from the partner, and decreased partner avoidance and criticism). [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ]
- Partners' psychological well-being and caregiver strain [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ]
- Gender and marital satisfaction as moderators of the effects of partner-assisted ED. [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734513
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Laura Porter, Ph.D.||Duke University|