CancerFACT-ICMNCT02651831
Development and Validation of a Health-related Quality of Life Instrument
An observational study of Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Focus groups and individual interviews and Questionnaire
- How many people
- 85 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jan 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be patients who are receiving treatment that modulates immune checkpoints and clinicians with expertise in this area.
Who may be able to join
- Patient Criteria
- Cancer diagnosis (any type, advanced or metastatic stage);
- Treatment with an agent or agents that modulate an immune checkpoint (any line of therapy);
- Age ≥ 18;
- English-speaking;
- ECOG PS 0-3
Show all 12Show fewer
- Able to complete questionnaires independently
- Able to provide informed consent.
- Completed treatment within a year of enrolment
- Clinician Criteria
- Must either treat patients with ICMs or manage side effects of patients treated with ICMs
- Be able to attend interviews and participate in discussions as part of the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- Focus groups and individual interviews, Questionnaire
- Keywords
- ICMs, Immune checkpoint modulators
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groups and individual interviewsOther
Focus groups conducted to explore general experiences, insights and concerns of those receiving ICM therapies. Individual semi-structured interviews to provide in-depth data on the themes identified in the focus groups.
QuestionnaireOther
Health related quality of life questionnaire (FACT-ICM) to be completed by patients
| Study group | Role | What they receive |
|---|---|---|
| 1A: Content Validation | Up to 4 focus groups of 6-10 cancer patients each will be conducted each lasting approximately 90 mins. An additional 10 to 15 patients will undergo individual semi-structured interviews each lasting around 60 minutes.
10-12 expert clinicians experienced in treating patients with ICMs or managing ICM toxicities will participate in a survey, and group or individual interviews. Receives: Other: Focus groups and individual interviews | |
| 1B: Face Validity | Patients who have been and are being treated with ICMs to complete draft questionnaire (FACT-ICM). Some patients who were involved in the first round of interviews will be re-interviewed, and interview naïve patients will also be included. Receives: Other: Questionnaire | |
| 2A: To measure test-retest reliability | Patients to complete FACT-ICM at at two time points separated by 5 to 14 days. Receives: Other: Questionnaire | |
| 2B: To confirm construct validity | To evaluate discriminative properties of FACT-ICM, scores will be compared between pre-defined groups of patients where differences are expected. Receives: Other: Questionnaire | |
| 2C: To determine responsiveness and MCID | Responsiveness testing: Patients will complete FACT-ICM within a week of starting treatment, then while on treatment and within 30 days after end of treatment (EOT) with ICMs.
MCID testing: In addition to the FACT-ICM score, patients undergoing serial assessment for responsiveness will also indicate how much better or worse they are using a 5-point rating scale. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmatory factor analysis of FACT-ICM PRO tool variables compared to content analysis and qualitative descriptives of patient focus groups and interviews in target group
Measured: 6 months
Secondary outcomes (4)
Change of score for each domain and also the total FACT-ICM score at baseline to 5-14 days for patients with minimal change in status
Measured: 5-14 days
Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected
Measured: 6 months
FACT-ICM change scores from baseline to within 30 days after end of treatment
Measured: Baseline, an average of 3 months, and within 30 days after end of treatment
Change in MCID values from baseline to within 30 days after end of treatment
Measured: Baseline, an average of 3 months, and within 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionJan 2024
- Study completionJan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651831
- Sponsor's protocol ID
- FACT-ICM
- Acronym
- FACT-ICM
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2016
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02651831
- Acronym / sponsor ID
- FACT-ICM / FACT-ICM
- Conditions
- Cancer
- Keywords
- ICMs, Immune checkpoint modulators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2024 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 11 Jan 2016 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1A: Content Validation | – | Other: Focus groups and individual interviewsUp to 4 focus groups of 6-10 cancer patients each will be conducted each lasting approximately 90 mins. An additional 10 to 15 patients will undergo individual semi-structured interviews each lasting around 60 minutes. 10-12 expert clinicians experienced in treating patients with ICMs or managing ICM toxicities will participate in a survey, and group or individual interviews. |
| 1B: Face Validity | – | Other: QuestionnairePatients who have been and are being treated with ICMs to complete draft questionnaire (FACT-ICM). Some patients who were involved in the first round of interviews will be re-interviewed, and interview naïve patients will also be included. |
| 2A: To measure test-retest reliability | – | Other: QuestionnairePatients to complete FACT-ICM at at two time points separated by 5 to 14 days. |
| 2B: To confirm construct validity | – | Other: QuestionnaireTo evaluate discriminative properties of FACT-ICM, scores will be compared between pre-defined groups of patients where differences are expected. |
| 2C: To determine responsiveness and MCID | – | Other: QuestionnaireResponsiveness testing: Patients will complete FACT-ICM within a week of starting treatment, then while on treatment and within 30 days after end of treatment (EOT) with ICMs. MCID testing: In addition to the FACT-ICM score, patients undergoing serial assessment for responsiveness will also indicate how much better or worse they are using a 5-point rating scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients who are receiving treatment that modulates immune checkpoints and clinicians with expertise in this area.
Key inclusion criteria (12 listed)
- Patient Criteria
- Cancer diagnosis (any type, advanced or metastatic stage);
- Treatment with an agent or agents that modulate an immune checkpoint (any line of therapy);
- Age ≥ 18;
- English-speaking;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Focus groups and individual interviewsFocus groups conducted to explore general experiences, insights and concerns of those receiving ICM therapies. Individual semi-structured interviews to provide in-depth data on the themes identified in the focus groups. | Other | 1A: Content Validation |
| QuestionnaireHealth related quality of life questionnaire (FACT-ICM) to be completed by patients | Other | 1B: Face Validity, 2A: To measure test-retest reliability, 2B: To confirm construct validity, 2C: To determine responsiveness and MCID |
Primary outcome
Confirmatory factor analysis of FACT-ICM PRO tool variables compared to content analysis and qualitative descriptives of patient focus groups and interviews in target group
Time frame: 6 months
4 secondary outcomes
Change of score for each domain and also the total FACT-ICM score at baseline to 5-14 days for patients with minimal change in status
Time frame: 5-14 days
Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected
Time frame: 6 months
FACT-ICM change scores from baseline to within 30 days after end of treatment
Time frame: Baseline, an average of 3 months, and within 30 days after end of treatment
Change in MCID values from baseline to within 30 days after end of treatment
Time frame: Baseline, an average of 3 months, and within 30 days after treatment
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 17 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. 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 17 Jan 2024. 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 Canada. 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?
Confirmatory factor analysis of FACT-ICM PRO tool variables compared to content analysis and qualitative descriptives of patient focus groups and interviews in target group (time frame: 6 months). 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 17 Jan 2024.