Nurse-Led Quality of Life Study-Phase I
- Conditions
- Quality of Life
- Interventions
- Behavioral: Quality of Life Intervention
- Registration Number
- NCT05853614
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
-> 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nurse-Led Quality of Life Intervention Quality of Life Intervention 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.
- Primary Outcome Measures
Name Time Method Intervention Acceptability Baseline to 3 months Acceptability is defined as \> 70% of patients, caregivers, and clinicians report favorable responses to the acceptability questions.
Rate of Participant Enrollment At screening 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
Rate of Participant Assessment Completion Baseline to 3 months 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.
- Secondary Outcome Measures
Name Time Method Change in Quality of Life (QOL) Baseline to 3 months 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.
Change in Coping Baseline to 3 months Assessed by Brief Cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.
Change in Financial Well-Being Baseline to 3 months Assessed by Comprehensive Score for Financial Toxicity (COST), an 11-item instrument measures financial toxicity.
Change in Symptom Burden Baseline to 3 months 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.
Change in Social Isolation Baseline to 3 months Assessed by PROMIS - Social Isolation, a 4-item set of person-centered measures that evaluates and monitors social wellbeing.
Change in Prognostic Awareness Baseline to 3 months Assessed by Prognostic Awareness Impact Scale (PAIS), a 34-item instrument measuring prognostic awareness and its psychological and behavioral impact.
Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period 1 year Number of Emergency Department Visits Through study completion, an average of two years Change in Anxiety Baseline to 3 months 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).
Change in Spiritual Wellbeing Baseline to 3 months 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.
Utilization of Supportive Care Services Through study completion, an average of two years Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Change in Symptom Management Baseline to 3 months Assessed by PROMIS - Self Efficacy for Managing Symptoms, a 4-item set of person-centered measures that evaluates and monitors physical health.
Change in Hope Baseline to 3 months 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.
Number of Days on Trial Through study completion, an average of two years Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Survival Through study completion, an average of two years Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Percentage of Hospice Utilization Through study completion, an average of two years Change in Depression Baseline to 3 months 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).
Change in Perception of the Nurse-Patient Relationship At 3 months Assessed by the RELATE scale, a 17-item instrument that measures patient perceptions of the nurse-patient relationship.
Trial Locations
- Locations (1)
Debra Lundquist
🇺🇸Boston, Massachusetts, United States