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OpenTrials
Completed

NCT Number: NCT03293849

A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors

In this randomized clinical trial, patients with Stage IV solid tumors will be enrolled in a patient navigator-led generalist palliative and supportive care intervention or in usual care led by their treating physician. The patient navigator will assess the patient's palliative and supportive care needs using standardized quality of life and symptoms questionnaires and present this assessment to a multidisciplinary team composed of oncologists and palliative care specialist. The multidisciplinary team will develop a personalized supportive care plan for the patient which will then be presented and discussed by the patient navigator. Those interventions which are accepted by the patient will be implemented by the patient navigator, who will also provide education and teaching. The patient navigator will also help eligible patients complete advanced directives according to local rules and regulations. The patient navigator will follow the patients both in person and by telephone to ensure that the recommended interventions have been implemented. Three months after enrollment the patients will undergo quality of life and symptom assessment once again, and the implementation of interventions will be recorded.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients 18 years of age and older
  • Newly diagnosed stage IV solid tumor
  • Recurrent stage IV solid tumor

Exclusion criteria

  • Homeless persons
  • History of drug abuse or alcoholism
  • Patients suffering from major psychotic disorders or uncontrolled psychiatric disorders
  • Mentally disabled patients
  • Incarcerated patients

Treatment and study plan

Patient Navigation

Other

The patient navigator will discuss the results and supportive care recommended interventions of the multidisciplinary team with the patient. Those interventions which are accepted by patient are initiated when possible, and referrals are made as planned. The study patient navigator will review advance directive planning with those patients who are candidates to complete an advanced directive under Mexican law, and will facilitate the resources to complete the advance directive.

Primary outcomes

  1. Referrals to Supportive Care Services

    Time frame: Three months

    Proportion of patients who agree to participate in the patient navigation program, complete the initial assessment, meet with the patient navigator to discuss advanced care planning and supportive care interventions and obtain the appropriate referrals and consultations.

Secondary outcomes

  1. Rate of advanced directive completion

    Time frame: Three months

    Obtaining a signed advanced directive

  2. Implementation of planned supportive care interventions

    Time frame: Three months

    Documentation of the planned interventions on the patient's medical record at end-of-study

  3. Changes in QOL

    Time frame: Three months

    Changes in QOL measured using the FACT-G from baseline.

  4. Changes in self-reported pain

    Time frame: Three months

    Changes in self reported pain measured using the BPI scale from baseline.

  5. Use of chemotherapy at the end of life

    Time frame: 18 months

    Interval between last administration of chemotherapy and death

  6. Healthcare utilization

    Time frame: 18 months

    Sum of hospital admissions, emergency room admissions and ICU admissions during the study period

  7. Survival

    Time frame: 18 months

    Overall survival (defined as time from study enrollment to last recorded visit or death)

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • Global Cancer Institute

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2017
Registry last updated
Feb 12, 2020

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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