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Completed

NCT Number: NCT05853614

Nurse-Led Quality of Life Study-Phase I

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).

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Key information

Conditions

Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Debra Lundquist

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of Life Intervention

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.

Primary outcomes

  1. Rate of Participant Enrollment

    Time frame: At screening

    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

  2. Rate of Participant Assessment Completion

    Time frame: Baseline to 3 months

    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.

  3. Intervention Acceptability

    Time frame: Baseline to 3 months

    Acceptability is defined as > 70% of patients, caregivers, and clinicians report favorable responses to the acceptability questions.

Secondary outcomes

  1. Change in Quality of Life (QOL)

    Time frame: Baseline to 3 months

    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.

  2. Change in Symptom Burden

    Time frame: Baseline to 3 months

    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.

  3. Change in Symptom Management

    Time frame: Baseline to 3 months

    Assessed by PROMIS - Self Efficacy for Managing Symptoms, a 4-item set of person-centered measures that evaluates and monitors physical health.

  4. Change in Hope

    Time frame: Baseline to 3 months

    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.

  5. Change in Coping

    Time frame: Baseline to 3 months

    Assessed by Brief Cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.

  6. Change in Social Isolation

    Time frame: Baseline to 3 months

    Assessed by PROMIS - Social Isolation, a 4-item set of person-centered measures that evaluates and monitors social wellbeing.

  7. Change in Financial Well-Being

    Time frame: Baseline to 3 months

    Assessed by Comprehensive Score for Financial Toxicity (COST), an 11-item instrument measures financial toxicity.

  8. Change in Anxiety

    Time frame: Baseline to 3 months

    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).

  9. Change in Depression

    Time frame: Baseline to 3 months

    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).

  10. Change in Prognostic Awareness

    Time frame: Baseline to 3 months

    Assessed by Prognostic Awareness Impact Scale (PAIS), a 34-item instrument measuring prognostic awareness and its psychological and behavioral impact.

  11. Change in Spiritual Wellbeing

    Time frame: Baseline to 3 months

    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.

  12. Change in Perception of the Nurse-Patient Relationship

    Time frame: At 3 months

    Assessed by the RELATE scale, a 17-item instrument that measures patient perceptions of the nurse-patient relationship.

  13. Survival

    Time frame: Through study completion, an average of two years

    Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.

  14. Number of Days on Trial

    Time frame: Through study completion, an average of two years

    Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.

  15. Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period

    Time frame: 1 year

  16. Number of Emergency Department Visits

    Time frame: Through study completion, an average of two years

  17. Utilization of Supportive Care Services

    Time frame: Through study completion, an average of two years

    Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.

  18. Percentage of Hospice Utilization

    Time frame: Through study completion, an average of two years

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Oncology Nursing Society

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 11, 2023
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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