Nurse-Led Quality of Life Study-Phase I

Mass General Brigham

Status: Completed

Conditions: Quality of Life

Treatments: Behavioral: Quality of Life Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05853614

22-695

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Nurse-Led Quality of Life Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Quality of Life Intervention