Nurse-Led Quality of Life Study-Phase I

NCT ID: NCT05853614

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2025-04-15

Brief Summary

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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

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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.

Conditions

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Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Quality of Life Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oncology Nursing Society

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Debra Marie Lundquist, R.N.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Debra Lundquist, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Debra Lundquist

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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22-695

Identifier Type: -

Identifier Source: org_study_id

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