NCT00734513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
Last Updated

October 26, 2023

Status Verified

August 1, 2008

Enrollment Period

5.2 years

First QC Date

August 13, 2008

Last Update Submit

October 24, 2023

Conditions

Cancer of the GI System-stages II III and IV

Keywords

GI CancerEmotional DisclosureBehavioral InterventionPartnerCouples

Outcome Measures

Primary Outcomes (1)

  • Patient's psychological adjustment

    Immediately after treatment and 8 weeks after completion of treatment

Secondary Outcomes (4)

  • Patient's physical and functional well-being

    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).

    Immediately after treatment and 8 weeks after completion of treatment

  • Partners' psychological well-being and caregiver strain

    Immediately after treatment and 8 weeks after completion of treatment

  • Gender and marital satisfaction as moderators of the effects of partner-assisted ED.

    Immediately after treatment and 8 weeks after completion of treatment

Study Arms (2)

1

EXPERIMENTAL

Partner-assisted Emotional Disclosure

Behavioral: Partner-assisted emotional disclosure

2

ACTIVE COMPARATOR

Cancer Education

Behavioral: Cancer Education

Interventions

Partner-assisted emotional disclosureBEHAVIORAL

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.

Also known as: Emotional Disclosure
1
Cancer EducationBEHAVIORAL

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.

Also known as: Education
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Laura Porter, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

January 1, 2003

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 26, 2023

Record last verified: 2008-08

Locations

US(1)