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Partner Assisted Emotional Disclosure for GI Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Cancer of the GI System; Stages II, III, and IV.

Thank you

Trial Information

Partner Assisted Emotional Disclosure for GI Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Patient's psychological adjustment

Outcome Time Frame:

Immediately after treatment and 8 weeks after completion of treatment

Safety Issue:

No

Principal Investigator

Laura Porter, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00011905

NCT ID:

NCT00734513

Start Date:

January 2003

Completion Date:

March 2008

Related Keywords:

  • Cancer of the GI System; Stages II, III, and IV.
  • GI Cancer
  • Emotional Disclosure
  • Behavioral Intervention
  • Partner
  • Couples

Name

Location

Duke University Medical Center Durham, North Carolina  27710