Nurse-Led Quality of Life Study-Phase I

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
A Nurse-Led Intervention to Enhance Quality of Life Among Early Phase Clinical Trial Participants: A Pilot Study

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Quality of Life Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient Inclusion Criteria: -> 18 years of age. Adults with cancer enrolled on an EP-CT in the Termeer Center at Massachusetts General Hospital. Able to read and respond to questions in English. Caregiver Inclusion Criteria: A relative or friend of the eligible patient whom the patient identifies as being involved in their medical care. -> 18 years of age. Verbally fluent in English. Clinician Inclusion Criteria: Clinician must be an oncology nurse. CRN for a minimum of 18 months. fulltime employee in the Termeer Center.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-Led Quality of Life Intervention<br>Participants and caregivers will complete study procedures as outlined: Completion of surveys at four timepoints (baseline, one month, two months, and three months) Three visits on-site with trained clinical research nursing staff. Semi-structured exit interviews with participants and caregivers. | Behavioral: Quality of Life Intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Baseline to 3 months | 
| Intervention Acceptability | Acceptability is defined as > 70% of patients, caregivers, and clinicians report favorable responses to the acceptability questions. | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline to 3 months | 
| 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. | 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. | 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. | Baseline to 3 months | 
| Change in Financial Well-Being | Assessed by Comprehensive Score for Financial Toxicity (COST), an 11-item instrument measures financial toxicity. | 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). | 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). | 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. | 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. | 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. | At 3 months | 
| Survival | Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots. | 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. | Through study completion, an average of two years | 
| Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period |  | 1 year | 
| Number of Emergency Department Visits |  | 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. | Through study completion, an average of two years | 
| Percentage of Hospice Utilization |  | Through study completion, an average of two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life