Partner-Assisted Emotional Disclosure for GI Cancer

October 24, 2023 updated by: Duke University

Partner Assisted Emotional Disclosure for GI Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient's psychological adjustment
Time Frame: Immediately after treatment and 8 weeks after completion of treatment
Immediately after treatment and 8 weeks after completion of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient's physical and functional well-being
Time Frame: Immediately after treatment and 8 weeks after completion of treatment
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
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
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
Immediately after treatment and 8 weeks after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Laura Porter, Ph.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimated)

August 14, 2008

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00011905
  • 1R01CA10073-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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