Nurse-Led Quality of Life Study-Phase I

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

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Behavioral: Quality of Life Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Debra Lundquist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-Led 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.	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.

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Oncology Nursing Society
• Investigators: Principal Investigator: Debra Lundquist, PhD, RN, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life
• Other Study ID Numbers: 22-695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No