An Intervention to Improve Outcomes in Patients With Advanced Cancer

Study Overview
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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.

Official Title
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An Intervention to Improve Outcomes in Patients With Advanced Cancer

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Symptom Education
* Behavioral: Intervention


Participation Criteria
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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- Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Information/Education Group<br>Assistance in using Symptom Management Toolkit | Behavioral: Symptom Education<br>* 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.<br>|
| Experimental: Nurse Intervention<br>Participants are given intensive nurse contacts to reduce uncertainty and maximize problem solving, and later, to transition to the treatment phase of their cancer. | Behavioral: Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncertainty | The MUIS-C contains 23 Likert scale items with scores that range from 1= strongly disagree to 5= strongly agree. | 1 month post baseline | 
| Uncertainty | The MUIS-C is a 23-item scale that asks the respondent to rate items on a scale of 1=strongly disagree to 5= strongly agree. | 3 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HADS- Anxiety | 7 items are rated on a 4-point scale. | 1 month post baseline | 
| HADS-Anxiety | 7 items are rated on a 4-point scale. | 3 months post baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial, symptom education, advanced cancer