Partner-Assisted Emotional Disclosure for GI Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00734513
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : November 25, 2016
Information provided by (Responsible Party):
Duke University

Brief Summary:
The long-range goal of this research is to develop better ways of helping GI cancer patients and their caregivers cope more effectively with the demands of the disease. The study is designed to test the hypothesis that a partner-assisted emotional disclosure intervention will be more effective in enhancing patient' psychological adjustment than a cancer education condition.

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: 1
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
Cancer Education
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

Primary Outcome Measures :
  1. Patient's psychological adjustment [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ]

Secondary Outcome Measures :
  1. Patient's physical and functional well-being [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ]
  2. 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 ]
  3. Partners' psychological well-being and caregiver strain [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • cancer of the GI system (esophagus, stomach, pancreas, liver, or colorectal; Stage II, III or IV), a life-expectancy of at least 6 months, living with a spouse or intimate partner in a committed relationship, English speaking, and an identified medical oncologist.

Exclusion Criteria:

  • None other than absence of inclusion criteria specified above

Information from the National Library of Medicine

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 identifier (NCT number): NCT00734513

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Principal Investigator: Laura Porter, Ph.D. Duke University

Responsible Party: Duke University Identifier: NCT00734513     History of Changes
Other Study ID Numbers: Pro00011905
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: August 2008

Keywords provided by Duke University:
GI Cancer
Emotional Disclosure
Behavioral Intervention