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Partner-Assisted Emotional Disclosure for GI Cancer

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Duke University

Status

Completed

Conditions

Cancer of the GI System-stages II III and IV

Treatments

Behavioral: Cancer Education
Behavioral: Partner-assisted emotional disclosure

Study type

Interventional

Funder types

Other

Identifiers

NCT00734513
Pro00011905
1R01CA10073-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

1
Experimental group
Description:
Partner-assisted Emotional Disclosure
Treatment:
Behavioral: Partner-assisted emotional disclosure
2
Active Comparator group
Description:
Cancer Education
Treatment:
Behavioral: Cancer Education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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