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NCT Number: NCT02543541

A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials

The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family. The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers. The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment. The team can make referrals to other specialists. Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.

Secondary Objective(s):

  • To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.

Exploratory:

  • To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
  • To compare caregiver burden and quality of life between the study arms.

Who can participate

Healthy volunteers accepted: Yes

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

Patient Inclusion Criteria:

  • Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
  • Patients are eligible to enroll on this study with or without the enrollment of their caregiver.

Patient Exclusion Criteria:

  • Patients diagnosed with a hematologic malignancy.

Caregiver Inclusion Criteria:

  • Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
  • Caregivers must be willing to complete surveys at baseline and on monthly basis.

Caregiver Exclusion Criteria:

  • Caregivers who are solely professional, paid caregivers

Treatment and study plan

Structured palliative care

Behavioral

Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.

Standard supportive care

Behavioral

Supportive care for the patient and caregiver will be provided by the treating oncologist.

Primary outcomes

  1. Average total MSAS score

    Time frame: Up to 6 months

    Assessment of patient burden

  2. Average total FACT-G score

    Time frame: Up to 6 months

    Measure patient quality of life

  3. Reason for study discontinuation (Patient reported outcome)

    Time frame: Up to 6 months

    Measure of central tendency for why patients discontinued the phase I study. Patient reported outcomes for reason for study discontinuation will be qualitatively assessed

  4. Duration on Study

    Time frame: Up to 6 months

    Measure of central tendency of the duration patients were on the phase I study. Duration on study will serve as the primary objective for sample size determination

  5. Adverse events

    Time frame: Up to 6 months

    Measure of central tendency of adverse events. AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities). The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed. An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE * GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event. These scores will be compared between study arms

Secondary outcomes

  1. Mean number of hours of palliative care services

    Time frame: Up to 6 months

    Mean number of hours utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency

  2. Type of palliative care services

    Time frame: Up to 6 months

    Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency

Other outcomes

  1. Frequency of adverse events of patients receiving structured and usual supportive care

    Time frame: Up to 6 months

  2. Average days on study

    Time frame: Up to 6 months

  3. Change in FACT-G score

    Time frame: From baseline to last contact, up to 6 months

    Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care

  4. Change in MSAS score

    Time frame: From baseline to last contact, up to 6 months

    Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care

  5. Change in CRA score

    Time frame: From baseline to last contact, up to 6 months

    Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care

  6. Change in QOLLTI-F score

    Time frame: From baseline to last contact, up to 6 months

    Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2015
Registry last updated
Apr 23, 2019

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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