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出境医 / 临床实验 / Quality of Life and Physical Fitness After Immune Checkpoint Inhibitors

Quality of Life and Physical Fitness After Immune Checkpoint Inhibitors

Study Description
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.


Condition or disease
Melanoma Non Small Cell Lung Cancer

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 Design
Layout table for study information
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
Arms and Interventions
Group/Cohort
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.
Outcome Measures
Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. cognitive function [ Time Frame: 3 years ]
    Hopkins Verbal Learning Test-Revised (HVLT-R);

  2. cognitive function [ Time Frame: 3 years ]
    Controlled Oral Word Association Test (COWA);

  3. cognitive function [ Time Frame: 3 years ]
    Trail Making Test (TMT)

  4. Physical fitness [ Time Frame: 3 years ]
    six-minute walk test (6MWT)

  5. endocrine function [ Time Frame: 3 years ]
    measurement of gonadal and pituitary function in blood

  6. Quality of life of caregivers [ Time Frame: 3 years ]
    Caregiver Quality of Life Index-Cancer (CQOLC)

  7. muscle strength [ Time Frame: 3 years ]
    Maximal voluntary isometric muscle force of the right and left extremity of extension of the knee, flexion of the knee, flexion of the elbow, extension of the elbow and grip-strength of the hand will be measured using a hand-held dynamometer.


Biospecimen Retention:   Samples With DNA
vena punction

Eligibility Criteria
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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
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.
Criteria

Inclusion Criteria:

  1. Patient 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.
  2. Age ≥18 years at time of immune checkpoint inhibitor treatment
  3. All previous or subsequent therapies allowed, including (brain) irradiation, surgery for metastases, chemotherapy, and targeted therapy, provided stable clinical situation at time of inclusion

Exclusion Criteria:

  1. Switch of systemic therapy or local antitumor intervention (surgery, radiotherapy) during last 2 months
  2. Inability to understand or abide to the study protocol
  3. Debilitating psychiatric illness
  4. Previous treatment for malignancy other than melanoma (excluding non-melanoma skin cancer, cervical intra-epithelial neoplasia (CIN) or carcinoma in situ of breast)
Contacts and Locations

Contacts
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Contact: J. Nuver, MD, PhD +31 50 361 2821 j.nuver@umcg.nl

Locations
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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         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Layout table for investigator information
Principal Investigator: J. Nuver, MD, PhD University Medical Center Groningen
Tracking Information
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
 (submitted: May 9, 2019)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 9, 2019)
  • cognitive function [ Time Frame: 3 years ]
    Hopkins Verbal Learning Test-Revised (HVLT-R);
  • cognitive function [ Time Frame: 3 years ]
    Controlled Oral Word Association Test (COWA);
  • cognitive function [ Time Frame: 3 years ]
    Trail Making Test (TMT)
  • Physical fitness [ Time Frame: 3 years ]
    six-minute walk test (6MWT)
  • endocrine function [ Time Frame: 3 years ]
    measurement of gonadal and pituitary function in blood
  • Quality of life of caregivers [ Time Frame: 3 years ]
    Caregiver Quality of Life Index-Cancer (CQOLC)
  • muscle strength [ Time Frame: 3 years ]
    Maximal voluntary isometric muscle force of the right and left extremity of extension of the knee, flexion of the knee, flexion of the elbow, extension of the elbow and grip-strength of the hand will be measured using a hand-held dynamometer.
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.

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
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
vena punction
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
  • Melanoma
  • Non Small Cell Lung Cancer
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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 9, 2019)
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:

  1. Patient 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.
  2. Age ≥18 years at time of immune checkpoint inhibitor treatment
  3. All previous or subsequent therapies allowed, including (brain) irradiation, surgery for metastases, chemotherapy, and targeted therapy, provided stable clinical situation at time of inclusion

Exclusion Criteria:

  1. Switch of systemic therapy or local antitumor intervention (surgery, radiotherapy) during last 2 months
  2. Inability to understand or abide to the study protocol
  3. Debilitating psychiatric illness
  4. Previous treatment for malignancy other than melanoma (excluding non-melanoma skin cancer, cervical intra-epithelial neoplasia (CIN) or carcinoma in situ of breast)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: J. Nuver, MD, PhD +31 50 361 2821 j.nuver@umcg.nl
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party J. Nuver, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
Investigators
Principal Investigator: J. Nuver, MD, PhD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date February 2021

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