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
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Apr 2023
Typical duration for not_applicable quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2023
CompletedStudy Start
First participant enrolled
April 15, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2025
CompletedNovember 28, 2025
November 1, 2025
2 years
April 13, 2023
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (18)
Change in Quality of Life (QOL)
Baseline to 3 months
Change in Symptom Burden
Baseline to 3 months
Change in Symptom Management
Baseline to 3 months
Change in Hope
Baseline to 3 months
Change in Coping
Baseline to 3 months
- +13 more secondary outcomes
Study Arms (1)
Nurse-Led Quality of Life Intervention
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \> 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.
- 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 must be an oncology nurse.
- CRN for a minimum of 18 months.
- fulltime employee in the Termeer Center.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Oncology Nursing Societycollaborator
Study Sites (1)
Debra Lundquist
Boston, Massachusetts, 02215, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Debra Lundquist, PhD, RN
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 13, 2023
First Posted
May 11, 2023
Study Start
April 15, 2023
Primary Completion
April 15, 2025
Study Completion
April 15, 2025
Last Updated
November 28, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.