Clinical trial NCT05853614: Nurse-Led Quality of Life Study-Phase I
Official title: A Nurse-Led Intervention to Enhance Quality of Life Among Early Phase Clinical Trial Participants: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Keywords: Quality of Life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Society
First posted: 2023-05-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Rate of Participant Enrollment
timeFrame: At screening
measure: Rate of Participant Assessment Completion
timeFrame: Baseline to 3 months
measure: Intervention Acceptability
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in Quality of Life (QOL)
timeFrame: Baseline to 3 months
measure: Change in Symptom Burden
timeFrame: Baseline to 3 months
measure: Change in Symptom Management
timeFrame: Baseline to 3 months
measure: Change in Hope
timeFrame: Baseline to 3 months
measure: Change in Coping
timeFrame: Baseline to 3 months
measure: Change in Social Isolation
timeFrame: Baseline to 3 months
measure: Change in Financial Well-Being
timeFrame: Baseline to 3 months
measure: Change in Anxiety
timeFrame: Baseline to 3 months
measure: Change in Depression
timeFrame: Baseline to 3 months
measure: Change in Prognostic Awareness
timeFrame: Baseline to 3 months
measure: Change in Spiritual Wellbeing
timeFrame: Baseline to 3 months
measure: Change in Perception of the Nurse-Patient Relationship
timeFrame: At 3 months
measure: Survival
timeFrame: Through study completion, an average of two years
measure: Number of Days on Trial
timeFrame: Through study completion, an average of two years
measure: Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period
timeFrame: 1 year
measure: Number of Emergency Department Visits
timeFrame: Through study completion, an average of two years
measure: Utilization of Supportive Care Services
timeFrame: Through study completion, an average of two years
measure: Percentage of Hospice Utilization
timeFrame: Through study completion, an average of two years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Debra Lundquist
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Debra Lundquist, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: