Quality of Life
Conditions
Keywords
Quality of Life
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.
Interventions
BEHAVIORALQuality of Life Intervention
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.
Sponsors
Oncology Nursing Society
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Intervention Acceptability | Baseline to 3 months | Acceptability is defined as \> 70% of patients, caregivers, and clinicians report favorable responses to the acceptability questions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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 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. |
| 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 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. |
| Survival | Through study completion, an average of two years | Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots. |
| 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. |
| 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 | 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 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. |
| 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 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. |
Countries
United States
Outcome results
None listed