Clinical trial NCT00734513: Partner-Assisted Emotional Disclosure for GI Cancer
Official title: Partner Assisted Emotional Disclosure for GI Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the GI System-stages II III and IV
Keywords: GI Cancer
Emotional Disclosure
Behavioral Intervention
Partner
Couples
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient's psychological adjustment
timeFrame: Immediately after treatment and 8 weeks after completion of treatment
Secondary outcomes:
measure: Patient's physical and functional well-being
timeFrame: Immediately after treatment and 8 weeks after completion of treatment
measure: 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).
timeFrame: Immediately after treatment and 8 weeks after completion of treatment
measure: Partners' psychological well-being and caregiver strain
timeFrame: Immediately after treatment and 8 weeks after completion of treatment
measure: Gender and marital satisfaction as moderators of the effects of partner-assisted ED.
timeFrame: Immediately after treatment and 8 weeks after completion of treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Laura Porter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: