Nurse-Led Quality of Life Study-Phase I

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05853614
• Other study ID #: 22-695
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 15, 2025

Study information

• Verified date: May 2023
• Source: Massachusetts General Hospital
• Contact: Debra Lundquist, PhD, RN
• Phone: (617) 724-7700
• Email: debra.lundquist[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: April 15, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• Quality 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.

Locations

Country	Name	City	State
United States	Debra Lundquist	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Oncology Nursing Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Intervention Acceptability	Acceptability is defined as > 70% of patients, caregivers, and clinicians report favorable responses to the acceptability questions.	Baseline to 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Financial Well-Being	Assessed by Comprehensive Score for Financial Toxicity (COST), an 11-item instrument measures financial toxicity.	Baseline to 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Survival	Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.	Through study completion, an average of two years
Secondary	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
Secondary	Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period		1 year
Secondary	Number of Emergency Department Visits		Through study completion, an average of two years
Secondary	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
Secondary	Percentage of Hospice Utilization		Through study completion, an average of two years