Rationale: Tremendous anti-tumor effects have been achieved using immune checkpoint inhibitors for melanoma and NSCLC with long lasting responses of more than 2 years in a substantial subgroup of patients. However, we are still largely unaware of the health-related quality of life of these patients. We should carefully and thoroughly assess the long-term burden of disease and treatment toxicity.
Objective: Primary Objective: to investigate health-related quality of life (HRQoL) of patients surviving 2 years or more after the first cycle of an immune checkpoint inhibitor for melanoma or NSCLC. Secondary Objectives: to assess neurocognitive function, endocrine function, cardiovascular risk, physical fitness, mood disorders, sexual problems, work participation in patients surviving 2 years or more after the first cycle of immune checkpoint inhibitor; to assess quality of life of the caregivers of these patients.
Study design: Observational cross-sectional study. Study population: Patients (age ≥18 years) with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both).
Main study parameters/endpoints: health-related quality of life (HRQoL) as measured using the EORTC Quality of life questionnaire (QLQ-C30). Secondary study parameters: possible late effects (neurocognitive dysfunction, endocrine disorders, dermatologic complaints, sexual disorders and infertility, increased cardiovascular risk, and fatigue), physical fitness, psychosocial issues related to work/education, mood disorders (anxiety and depression), patient and treatment-related factors potentially influencing development of late effects, well-being, and quality of life of caregivers.
Condition or disease |
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Melanoma Non Small Cell Lung Cancer |
Study Type : | Observational |
Estimated Enrollment : | 225 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Quality of Life, Cognitive Function, and Physical Fitness of Melanoma and NSCLC Patients Surviving More Than 2 Years After Immune Checkpoint Inhibitor Therapy |
Actual Study Start Date : | October 4, 2018 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2021 |
Group/Cohort |
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Patients with melanoma or NSCLC
Patients (age ≥18 years) with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) within the Department of Medical Oncology or Pulmonary Oncology of the UMCG.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: J. Nuver, MD, PhD | +31 50 361 2821 | j.nuver@umcg.nl |
Netherlands | |
University Medical Center Groningen | Recruiting |
Groningen, Netherlands, 9713 GZ | |
Contact: J. Nuver, MD, PhD +31 50 361 2821 j.nuver@umcg.nl | |
Principal Investigator: J. Nuver, MD, PhD |
Principal Investigator: | J. Nuver, MD, PhD | University Medical Center Groningen |
Tracking Information | |||||
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First Submitted Date | March 5, 2018 | ||||
First Posted Date | May 10, 2019 | ||||
Last Update Posted Date | February 2, 2021 | ||||
Actual Study Start Date | October 4, 2018 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Health-related quality of life (HRQoL) [ Time Frame: 3 years ] European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core questionnaire (QLQ-C30)
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Quality of Life and Physical Fitness After Immune Checkpoint Inhibitors | ||||
Official Title | Quality of Life, Cognitive Function, and Physical Fitness of Melanoma and NSCLC Patients Surviving More Than 2 Years After Immune Checkpoint Inhibitor Therapy | ||||
Brief Summary |
Rationale: Tremendous anti-tumor effects have been achieved using immune checkpoint inhibitors for melanoma and NSCLC with long lasting responses of more than 2 years in a substantial subgroup of patients. However, we are still largely unaware of the health-related quality of life of these patients. We should carefully and thoroughly assess the long-term burden of disease and treatment toxicity. Objective: Primary Objective: to investigate health-related quality of life (HRQoL) of patients surviving 2 years or more after the first cycle of an immune checkpoint inhibitor for melanoma or NSCLC. Secondary Objectives: to assess neurocognitive function, endocrine function, cardiovascular risk, physical fitness, mood disorders, sexual problems, work participation in patients surviving 2 years or more after the first cycle of immune checkpoint inhibitor; to assess quality of life of the caregivers of these patients. Study design: Observational cross-sectional study. Study population: Patients (age ≥18 years) with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both). Main study parameters/endpoints: health-related quality of life (HRQoL) as measured using the EORTC Quality of life questionnaire (QLQ-C30). Secondary study parameters: possible late effects (neurocognitive dysfunction, endocrine disorders, dermatologic complaints, sexual disorders and infertility, increased cardiovascular risk, and fatigue), physical fitness, psychosocial issues related to work/education, mood disorders (anxiety and depression), patient and treatment-related factors potentially influencing development of late effects, well-being, and quality of life of caregivers. |
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Detailed Description | Participation in the study will include one study visit of approximately 2.5 hours. If possible, the study visit will be combined with a regular follow-up visit. Vena puncture is the only invasive procedure, with low risk of adverse effects. Blood will be drawn after an overnight fast. To minimize the duration of the visit, patients will be offered to fill out the questionnaires at home. Individual adverse test results will be reported to a participants' treating physician to enable treatment or follow-up as indicated. The results of the full study group will be used to guide future interventions and support for melanoma and NSCLC patients. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description:
vena punction
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Sampling Method | Probability Sample | ||||
Study Population | An estimated 80 adult patients with advanced melanoma and 250 patients with NSCLC are treated with immune checkpoint inhibitors in the UMCG each year. Around 20% of these patients are expected to survive ≥2 years since their first cycle of immune checkpoint inhibitor. Patients will be recruited and study measurements will be performed within 3 year after start of study. We expect to include 25 melanoma and 50 NSCLC patients per treatment year. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Patients with melanoma or NSCLC
Patients (age ≥18 years) with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) within the Department of Medical Oncology or Pulmonary Oncology of the UMCG.
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
225 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | June 2021 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03946007 | ||||
Other Study ID Numbers | 201800146 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | J. Nuver, University Medical Center Groningen | ||||
Study Sponsor | University Medical Center Groningen | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University Medical Center Groningen | ||||
Verification Date | February 2021 |