An Intervention to Improve Outcomes in Patients With Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-08-31

Brief Summary

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1.) To integrate discharge planning into an intervention provided by advanced practice nurses (APRNs)for patients with advanced cancer, 2.) To evaluate the effects of the intervention, and 3.) To explore the reach, adoption, and implementation of the intervention to facilitate the transition of patients from surgery/biopsy/chemotherapy to medical oncology in a comprehensive cancer center.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Information/Education Group

Assistance in using Symptom Management Toolkit

Group Type ACTIVE_COMPARATOR

Symptom Education

Intervention Type BEHAVIORAL

Participants are given a Symptom Education Toolkit at baseline and at each visit thereafter (1 month and 3 month) are encouraged to use the Toolkit for symptoms they are experiencing. They are also encouraged to use resources available to them.

Nurse Intervention

Participants are given intensive nurse contacts to reduce uncertainty and maximize problem solving, and later, to transition to the treatment phase of their cancer.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

Participants are visited/contacted by an intervention nurse ten times over a 12-week period for the purpose of helping them to manage uncertainty and distress,to boost their problem-solving skills, and to transition to treatment.

Interventions

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Symptom Education

Participants are given a Symptom Education Toolkit at baseline and at each visit thereafter (1 month and 3 month) are encouraged to use the Toolkit for symptoms they are experiencing. They are also encouraged to use resources available to them.

Intervention Type BEHAVIORAL

Intervention

Participants are visited/contacted by an intervention nurse ten times over a 12-week period for the purpose of helping them to manage uncertainty and distress,to boost their problem-solving skills, and to transition to treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* primary diagnosis of advanced lung, GI, Head \& Neck, and Lung cancers
* post-surgical/or post-biopsy with physician's order for cancer treatment
* age 21 years or older
* lives within 50 of Yale New Haven Hospital
* has 2 or more co-morbid conditions
* has an emotional distress thermometer score of greater than or equal to 4-

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No