Colorectal NeoplasmsDEQOLAGENCT02672657
Determinants of Quality Of Life in AGEd Cancer Patients
An observational study of Colorectal Neoplasms and Prostatic Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Neoplasms, Prostatic Neoplasms
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2016to Dec 2019
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients presenting at the participating hospitals with newly diagnosed colorectal or prostate cancer and referred by an oncologist, surgeon, radiotherapist, or other specialist to the hospital geriatric oncology clinics for a multidimensional geriatric assessment before the initiation of cancer treatment will be eligible for inclusion, regardless of stage at diagnosis and plans for treatment
Who may be able to join
- Aged 70 or more
- With a new histologically confirmed diagnosis of colorectal or prostate cancer
- With a Comprehensive Geriatric Assessment (CGA) performed before the initiation of cancer treatment
- Having expressed their oral non-opposition to participate in the study
- Affiliated to a health insurance scheme
Who cannot join
- Expected survival inferior to 6 months, based on the clinical appreciation from the physician in charge of the enrollment
- Cancer recurrence in patients previously treated
- Physical, cognitive or linguistic incapacity to complete questionnaires
- Caregivers Inclusion criteria
- Aged 18 or more
- Nonprofessionally, partially or fully helping the patient in daily activities and accompanying the patient to visits; familial ties with the patient are not required (spouse, child, friend or neighbor)
Show all 9Show fewer
- In contact with the patient more than once a week
- Defined by the patient during the inclusion visit as the main caregiver
- Physical, cognitive or linguistic incapacity to complete questionnaires
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital Henri Mondor
Créteil, 94010
Philippe Caillet, (0)1 49 81 24 86 ext. +33, philippe.caillet@hmn.aphp.fr
- Recruiting
CHRU Nancy
Nancy, 54000
Jean Yves Niemier, (0)3 83 15 32 20 ext. +33, jy.niemier@chu-nancy.fr
- Recruiting
Hôpital Saint Louis
Paris, 75010
Pierre Mongiat-Artus, (0)1 42 49 96 23 ext. +33, pierre.mongiat-artus@sls.aphp.fr
About this study
Official title: Assessing the Evolution and Determinants of Quality of Life in Elderly Cancer Patients and Their Caregivers: a Prospective Multicenter Observational Cohort Study.
Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in older patients with cancer. Such determinants may include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features, but also practical organization of care -frequency, geographical distance, supporting measures -, or psychosocial and material support - social network, housing conditions and contextual neighborhood features. Comparatively to dementia or cancer in younger patients, little is known in the oncogeriatric field of the impact on caregivers' perceived burden and HRQol of the support they provide to patients. Further, the potential interactions between patients' and caregivers' HRQoL remain largely unknown, while caregivers are often themselves old with chronic diseases and/or daily living activities' limitations.
The DEQOLAGE study is a prospective observational cohort study that aims to describe the HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first year following the diagnosis of the disease as well as the HRQoL and burden in their main caregivers. This study will allow a comprehensive assessment of multiple determinants of HRQoL operating at different levels, including individual (cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features), contextual (social network, housing conditions and contextual neighborhood features) and organizational factors (frequency, geographical distance, supporting measures). We also hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and perceived burden. Quality of life measurement will be based on two recent scales specifically designed for the elderly to confirm their psychometric properties and in-field feasibility.
- Conditions
- Colorectal Neoplasms, Prostatic Neoplasms
- Keywords
- Health-Related Quality of life, Cancer, Elderly, Caregivers
- Medical subject headings
- Colorectal Neoplasms, Prostatic Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HRQoL of patients and their caregivers as assessed by the generic WHOQOL-BREF questionnaires
Measured: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients and their caregivers if aged >70 years as assessed by the WHOQOL-OLD questionnaire
Measured: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients as assessed by the specific EORTC-QLQ C30 questionnaire
Measured: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients as assessed by the specific EORTC QLQ-ELD14 questionnaire
Measured: At baseline, 3, 6, and 12 months
Changes in burden of patients' caregivers as assessed by the Zarit burden inventory questionnaire
Measured: At baseline, 3, 6, and 12 months
Secondary outcomes (5)
Psychometric properties of the HRQoL questionnaire WHOQOL-OLD (validity, reliability, sensitivity to change, feasibility)
Measured: At baseline, 3, 6, and 12 months
Psychometric properties of the HRQoL questionnaire EORTC QLQ-ELD14 (validity, reliability, sensitivity to change, feasibility)
Measured: At baseline, 3, 6, and 12 months
Prognostic value of baseline HRQoL measurements on cancer progression-free survival
Measured: At baseline, 3, 6, and 12 months
Prognostic value of baseline HRQoL measurements on overall survival
Measured: At baseline, 3, 6, and 12 months
Prognostic value of baseline HRQoL measurements on patient's functional decline, defined as any decrease in the ADL scale
Measured: At baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Paris 12 Val de Marne University, Research Team APEMAC EA4360, University of Lorraine, Unité de Recherche Clinique Mondor, Hôpital Henri Mondor, Institut de Cancérologie de Lorraine, Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne, Quality of life and cancer clinical research platform, Ligue contre le cancer, France, Conseil Régional de Lorraine, France
- Responsible party
- Sponsor
- Investigators
- Christine Perret-Guillaume, Study chair, Central Hospital, Nancy, FranceElena Paillaud, Study chair, Hôpital Albert Chenevier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672657
- Sponsor's protocol ID
- 2014-A00317-40
- Acronym
- DEQOLAGE
- Status last verified
- Aug 2016
- First submitted
- 14 Jan 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Evolution and Determinants of Quality of Life in Elderly Cancer Patients and Their Caregivers: a Prospective Multicenter Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT02672657
- Acronym / sponsor ID
- DEQOLAGE / 2014-A00317-40
- Conditions
- Colorectal Neoplasms, Prostatic Neoplasms
- Keywords
- Health-Related Quality of life, Cancer, Elderly, Caregivers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Paris 12 Val de Marne University, Research Team APEMAC EA4360, University of Lorraine, Unité de Recherche Clinique Mondor, Hôpital Henri Mondor, Institut de Cancérologie de Lorraine, Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne, Quality of life and cancer clinical research platform, Ligue contre le cancer, France, Conseil Régional de Lorraine, France
- Study start
- Feb 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 3 Feb 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.
Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in older patients with cancer. Such determinants may include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features, but also practical organization of care -frequency, geographical distance, supporting measures -, or psychosocial and material support - social network, housing conditions and contextual neighborhood features. Comparatively to dementia or cancer in younger patients, little is known in the oncogeriatric field of the impact on caregivers' perceived burden and HRQol of the support they provide to patients. Further, the potential interactions between patients' and caregivers' HRQoL remain largely unknown, while caregivers are often themselves old with chronic diseases and/or daily living activities' limitations.
The DEQOLAGE study is a prospective observational cohort study that aims to describe the HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first year following the diagnosis of the disease as well as the HRQoL and burden in their main caregivers. This study will allow a comprehensive assessment of multiple determinants of HRQoL operating at different levels, including individual (cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features), contextual (social network, housing conditions and contextual neighborhood features) and organizational factors (frequency, geographical distance, supporting measures). We also hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and perceived burden. Quality of life measurement will be based on two recent scales specifically designed for the elderly to confirm their psychometric properties and in-field feasibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients presenting at the participating hospitals with newly diagnosed colorectal or prostate cancer and referred by an oncologist, surgeon, radiotherapist, or other specialist to the hospital geriatric oncology clinics for a multidimensional geriatric assessment before the initiation of cancer treatment will be eligible for inclusion, regardless of stage at diagnosis and plans for treatment
Key inclusion criteria (5 listed)
- Aged 70 or more
- With a new histologically confirmed diagnosis of colorectal or prostate cancer
- With a Comprehensive Geriatric Assessment (CGA) performed before the initiation of cancer treatment
- Having expressed their oral non-opposition to participate in the study
- Affiliated to a health insurance scheme
Key exclusion criteria (9 listed)
- Expected survival inferior to 6 months, based on the clinical appreciation from the physician in charge of the enrollment
- Cancer recurrence in patients previously treated
- Physical, cognitive or linguistic incapacity to complete questionnaires
- Caregivers Inclusion criteria
- Aged 18 or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in HRQoL of patients and their caregivers as assessed by the generic WHOQOL-BREF questionnaires
Time frame: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients and their caregivers if aged >70 years as assessed by the WHOQOL-OLD questionnaire
Time frame: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients as assessed by the specific EORTC-QLQ C30 questionnaire
Time frame: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients as assessed by the specific EORTC QLQ-ELD14 questionnaire
Time frame: At baseline, 3, 6, and 12 months
Changes in burden of patients' caregivers as assessed by the Zarit burden inventory questionnaire
Time frame: At baseline, 3, 6, and 12 months
5 secondary outcomes
Psychometric properties of the HRQoL questionnaire WHOQOL-OLD (validity, reliability, sensitivity to change, feasibility)
Time frame: At baseline, 3, 6, and 12 months
Psychometric properties of the HRQoL questionnaire EORTC QLQ-ELD14 (validity, reliability, sensitivity to change, feasibility)
Time frame: At baseline, 3, 6, and 12 months
Prognostic value of baseline HRQoL measurements on cancer progression-free survival
Time frame: At baseline, 3, 6, and 12 months
Prognostic value of baseline HRQoL measurements on overall survival
Time frame: At baseline, 3, 6, and 12 months
Prognostic value of baseline HRQoL measurements on patient's functional decline, defined as any decrease in the ADL scale
Time frame: At baseline, 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Christine Perret-Guillaume study chair
Central Hospital, Nancy, France
Elena Paillaud study chair
Hôpital Albert Chenevier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Prostatic Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Etienne Audureau, Md, PhD ((0)1 49 81 36 64 ext. +33, etienne.audureau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HRQoL of patients and their caregivers as assessed by the generic WHOQOL-BREF questionnaires (time frame: At baseline, 3, 6, and 12 months). The study lists 5 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 26 Aug 2016.