Partner-Assisted Emotional Disclosure for GI Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734513
First received: August 13, 2008
Last updated: April 9, 2013
Last verified: August 2008
  Purpose

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 Intervention
Cancer of the GI System; Stages II, III, and IV.
Behavioral: Partner-assisted emotional disclosure
Behavioral: Cancer Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Partner Assisted Emotional Disclosure for GI Cancer

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Patient's psychological adjustment [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's physical and functional well-being [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Partners' psychological well-being and caregiver strain [ Time Frame: Immediately after treatment and 8 weeks after completion of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: January 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734513

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734513     History of Changes
Other Study ID Numbers: Pro00011905, 1R01CA10073-01A1
Study First Received: August 13, 2008
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014