Cancer Clinical Trial
Official title:
Development and Validation of a Health-related Quality of Life Instrument: Functional Assessment of Cancer Therapy - Immune Checkpoint Modulators, an Investigator Initiated Study (FACT-ICM).
This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint modulator (ICM) therapy. This instrument could be used to in clinical trials to evaluate HRQOL for patients treated with novel ICMs and ICM combinations that might ultimately influence decisions about regulatory approval, as well as improved understanding of chronic treatment effects on patient well-being, understanding reasons for treatment non-adherence, and developing strategies to improve adherence and evaluating clinical outcomes.
Immune Checkpoint Modulators (ICMs) are associated with significant adverse events. Currently there are no validated patient reported outcome (PRO) tools to assess health related quality of life (HRQOL) specifically in patients receiving ICMs. HRQOL is a multidimensional concept of a patient's perceived well-being that can be affected by disease and treatment. There is an urgent need to assess the impact of ICMs on HRQOL, to better understand the balance between efficacy and toxicity with these agents. This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint inhibitor (ICM) therapy (FACT-ICM). The core domains of the FACT-ICM will include physical, emotional, family and social, and functional well being. In addition, the proposed study will develop a toxicity sub-scale related to resultant toxicities from ICM therapy. The HRQOL will be developed through focus groups and interviews with patients treated with ICMs, and clinicians treating patients with ICMs, to understand how treatment with ICMs impacts HRQOL, as well as explore general experiences, insights and concerns of those receiving ICM therapies. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
| Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
| Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
| Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
| Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
| Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
| Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
| Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
| Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
| Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|