The purpose of this study is to pilot test a brief, population-specific nurse-led, quality of life (QOL) intervention with early phase cancer clinical trial (EP-CT) participants. The name of the intervention used in this research study is: -Nurse-Led Quality of Life Intervention (comprised of nurse-patient relationship, assessment and monitoring of participant QOL, and interdisciplinary team meetings led by the CRN (clinical research nurse).
This is a single-site study evaluating the feasibility and acceptability as well as patient-reported and clinical outcomes of a nurse-led, quality of life intervention with EP-CT participants. The research study procedures include obtaining consent to participate, meeting with research nurses monthly for three months, completing questionnaires, and an interview with the study staff at the end of the study. Participation in this research study is expected to be for a total of six months. It is expected that about 35 people, 25 caregivers, and 10 clinicians will take part in this research study. The Oncology Nursing Foundation is supporting this research study by providing funding.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Comprised of three components: (1) establishment of clinical research nurse (CRN) and patient relationship, (2) assessment and monitoring of physical, psychological, social, and spiritual well-being and patient-reported outcomes, and (3) weekly, interdisciplinary team meetings led by CRN.
Debra Lundquist
Boston, Massachusetts, United States
Rate of Participant Enrollment
The study will be feasible if at least 60% (95% confidence interval of +/-12%) enrollment of approached and eligible patients agree to participate in the study and sign informed consent
Time frame: At screening
Rate of Participant Assessment Completion
This study will be feasible if at least 70% (95% confidence interval of +/- 15%) of enrolled participants will complete a minimum of 60% of their patient-reported symptom assessments within the study period.
Time frame: Baseline to 3 months
Intervention Acceptability
Acceptability is defined as \> 70% of patients, caregivers, and clinicians report favorable responses to the acceptability questions.
Time frame: Baseline to 3 months
Change in Quality of Life (QOL)
Assessed by Functional Assessment of Cancer Therapy-General (FACT-G), a questionnaire comprised of 27 items with scale ratings validated to measure physical, emotional, social, and functional well-being of clinical trial participants.
Time frame: Baseline to 3 months
Change in Symptom Burden
Assessed through the Edmonton Symptom Assessment- revised scale (ESAS-R), a 10-item measure to assess symptoms. The ESAS-R score range 0-100 with higher scores indicating worse symptom burden.
Time frame: Baseline to 3 months
Change in Symptom Management
Assessed by PROMIS - Self Efficacy for Managing Symptoms, a 4-item set of person-centered measures that evaluates and monitors physical health.
Time frame: Baseline to 3 months
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Change in Hope
Assessed by the Herth Hope Index (HHI), which measures various dimensions of hope using a 4-point Likert scale that ranges from 1 (strongly disagree) to 4 (strongly agree) with items #3 and #6 reverse-coded.
Time frame: Baseline to 3 months
Change in Coping
Assessed by Brief Cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.
Time frame: Baseline to 3 months
Change in Social Isolation
Assessed by PROMIS - Social Isolation, a 4-item set of person-centered measures that evaluates and monitors social wellbeing.
Time frame: Baseline to 3 months
Change in Financial Well-Being
Assessed by Comprehensive Score for Financial Toxicity (COST), an 11-item instrument measures financial toxicity.
Time frame: Baseline to 3 months
Change in Anxiety
Assessed by Patient Health Questionnaire-4 (PHQ-4), a brief self-report validated questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).
Time frame: Baseline to 3 months
Change in Depression
Assessed by Patient Health Questionnaire-4 (PHQ-4), a brief self-report validated questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).
Time frame: Baseline to 3 months
Change in Prognostic Awareness
Assessed by Prognostic Awareness Impact Scale (PAIS), a 34-item instrument measuring prognostic awareness and its psychological and behavioral impact.
Time frame: Baseline to 3 months
Change in Spiritual Wellbeing
Assessed by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT - Sp), a 12-item questionnaire that measures spiritual well-being in cancer and other chronic illnesses.
Time frame: Baseline to 3 months
Change in Perception of the Nurse-Patient Relationship
Assessed by the RELATE scale, a 17-item instrument that measures patient perceptions of the nurse-patient relationship.
Time frame: At 3 months
Survival
Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Time frame: Through study completion, an average of two years
Number of Days on Trial
Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Time frame: Through study completion, an average of two years
Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period
Time frame: 1 year
Number of Emergency Department Visits
Time frame: Through study completion, an average of two years
Utilization of Supportive Care Services
Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Time frame: Through study completion, an average of two years
Percentage of Hospice Utilization
Time frame: Through study completion, an average of two years