Quality of LifeNCT05853614
Nurse-Led Quality of Life Study-Phase I
A study testing Quality of Life Intervention in people with Quality of Life, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Quality of Life Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: A Nurse-Led Intervention to Enhance Quality of Life Among Early Phase Clinical Trial Participants: A Pilot Study
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).
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Quality of Life Intervention
- Keywords
- Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Quality of Life Intervention | Experimental | 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. Receives: Behavioral: Quality of Life Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline to 3 months
Intervention Acceptability
Acceptability is defined as > 70% of patients, caregivers, and clinicians report favorable responses to the acceptability questions.
Measured: Baseline to 3 months
Secondary outcomes (18)
Change in Quality of Life (QOL)
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.
Measured: Baseline to 3 months
Change in Symptom Burden
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.
Measured: Baseline to 3 months
Change in Symptom Management
Assessed by PROMIS - Self Efficacy for Managing Symptoms, a 4-item set of person-centered measures that evaluates and monitors physical health.
Measured: Baseline to 3 months
Change in Hope
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.
Measured: Baseline to 3 months
Change in Coping
Assessed by Brief Cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.
Measured: Baseline to 3 months
Change in Social Isolation
Assessed by PROMIS - Social Isolation, a 4-item set of person-centered measures that evaluates and monitors social wellbeing.
Measured: Baseline to 3 months
Change in Financial Well-Being
Assessed by Comprehensive Score for Financial Toxicity (COST), an 11-item instrument measures financial toxicity.
Measured: Baseline to 3 months
Change in Anxiety
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).
Measured: Baseline to 3 months
Change in Depression
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).
Measured: Baseline to 3 months
Change in Prognostic Awareness
Assessed by Prognostic Awareness Impact Scale (PAIS), a 34-item instrument measuring prognostic awareness and its psychological and behavioral impact.
Measured: Baseline to 3 months
Change in Spiritual Wellbeing
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.
Measured: Baseline to 3 months
Change in Perception of the Nurse-Patient Relationship
Assessed by the RELATE scale, a 17-item instrument that measures patient perceptions of the nurse-patient relationship.
Measured: At 3 months
Survival
Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Measured: Through study completion, an average of two years
Number of Days on Trial
Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Measured: Through study completion, an average of two years
Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period
Measured: 1 year
Number of Emergency Department Visits
Measured: Through study completion, an average of two years
Utilization of Supportive Care Services
Calculated by log rank test, cox proportional hazard modeling, and Kaplan Meyer plots.
Measured: Through study completion, an average of two years
Percentage of Hospice Utilization
Measured: Through study completion, an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start15 Apr 2023
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oncology Nursing Society
- Responsible party
- Principal investigator, Debra Marie Lundquist, R.N., Massachusetts General Hospital
- Investigators
- Debra Lundquist, PhD, RN, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853614
- Sponsor's protocol ID
- 22-695
- Status last verified
- Nov 2025
- First submitted
- 13 Apr 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-Led Intervention to Enhance Quality of Life Among Early Phase Clinical Trial Participants: A Pilot Study
- ClinicalTrials.gov ID
- NCT05853614
- Acronym / sponsor ID
- 22-695
- Conditions
- Quality of Life
- Keywords
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Oncology Nursing Society
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Quality of Life Intervention | Experimental | Behavioral: Quality of Life InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life InterventionComprised 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. | Behavioural | Nurse-Led Quality of Life Intervention |
Primary outcome
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
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.
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.
18 secondary outcomes
Change in Quality of Life (QOL)
Time frame: Baseline to 3 months
Change in Symptom Burden
Time frame: Baseline to 3 months
Change in Symptom Management
Time frame: Baseline to 3 months
Change in Hope
Time frame: Baseline to 3 months
Change in Coping
Time frame: Baseline to 3 months
Change in Social Isolation
Time frame: Baseline to 3 months
Change in Financial Well-Being
Time frame: Baseline to 3 months
Change in Anxiety
Time frame: Baseline to 3 months
Change in Depression
Time frame: Baseline to 3 months
Change in Prognostic Awareness
Time frame: Baseline to 3 months
Change in Spiritual Wellbeing
Time frame: Baseline to 3 months
Change in Perception of the Nurse-Patient Relationship
Time frame: At 3 months
Survival
Time frame: Through study completion, an average of two years
Number of Days on Trial
Time frame: Through study completion, an average of two years
Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period
Time frame: 1 year
Number of Emergency Department Visits
Time frame: Through study completion, an average of two years
Utilization of Supportive Care Services
Time frame: Through study completion, an average of two years
Percentage of Hospice Utilization
Time frame: Through study completion, an average of two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Lundquist, PhD, RN principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life Intervention in people with Quality of Life, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participant Enrollment (time frame: At screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.