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OpenTrials
Completed

NCT Number: NCT01272024

An Intervention to Improve Outcomes in Patients With Advanced Cancer

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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Key information

Conditions

Cancer Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yale New Haven Hospital/Smilow Cancer Hospital

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symptom Education

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.

Intervention

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.

Primary outcomes

  1. Uncertainty

    Time frame: 1 month post baseline

    The MUIS-C contains 23 Likert scale items with scores that range from 1= strongly disagree to 5= strongly agree.

  2. Uncertainty

    Time frame: 3 months post-baseline

    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.

Secondary outcomes

  1. HADS- Anxiety

    Time frame: 1 month post baseline

    7 items are rated on a 4-point scale.

  2. HADS-Anxiety

    Time frame: 3 months post baseline.

    7 items are rated on a 4-point scale.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: TEAMS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2011
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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