Ignite Creation Date:
2024-05-06 @ 5:38 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05371158
Status:
UNKNOWN
Last Update Posted:
2022-05-12
First Post:
2022-03-16
Brief Title:
Effectiveness of Online ACT for Pain Interference in Cancer Survivors With Chronic Painful CIPN
Sponsor:
Daniëlle van de Graaf
Organization:
Tilburg University
Study Overview
Official Title:
Patient-centered Development and Effectiveness of Online Acceptance and Commitment Therapy for Pain Interference in Cancer Survivors With Persistent Painful Chemotherapy-induced Neuropathy
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QLIPP-CIPN
Brief Summary:
Rationale An average of 30 of adult cancer survivors suffers from chemotherapy-induced peripheral neuropathy CIPN 6 months after completion of chemotherapy and their quality of life QoL is strongly affected due to these symptoms Treatment options are limited
Objective The goal of this study is to examine the effectiveness of an online psychological intervention based on Acceptance and Commitment Therapy ACT in a Randomized Controlled Trial RCT and compared to a treatment-as-usual control condition TAU We aim to improve pain interference in cancer survivors with chronic painful CIPN present for at least 3 months in the curative disease phase who were treated with chemotherapy treatment at least 6 months ago irrespective of disease site
Study design It concerns a test of effectiveness of the ACT intervention in an RCT on quality of life In total 146 participants will be randomly allocated to one of two groups the online ACT intervention with therapist email guidance or a control condition that receives treatment-as-usual Patients in the control condition can follow the online ACT intervention directly after the 3 month-follow up measurement Self-reported questionnaires will be conducted at baseline after the intervention and at 3- and 6-month follow-up Additionally interviews will be executed with a subgroup of interested patients afterwards to explore intervention effects more in-depth Participants will be sampled via various patient organizations oncologists and advertisements distributed via the PROFILES-registry that contains ongoing research projects on CIPN Data will be collected online via the PROFILES-registry
Study population The population consists of adult cancer survivors in the curative disease phase suffering from painful CIPN for at least 3 months and who received chemotherapy treatment 6 or more months ago
Intervention An online ACT intervention was developed in the first phase of the QLIPP-CIPN study In this study phase insights into daily limitations and quality of life of the patient population were gained which served as the basis of the patient-centered development of the online ACT intervention following the CeHRes roadmap for participatory eHealth design The intervention includes an 8-week self-management course containing 6 modules regarding psycho-education and ACT- processes By means of text and exercises people learn to carry out value-oriented goals in daily life with pain To do this they learn new ways of coping with pain including reducing pain avoidance and increasing pain acceptance Additionally participants will receive email guidance
Main study parametersendpoint Pain interference in daily life using subscale Interference of the Multidimensional Pain Inventory MPI This scale focuses on a psychosocial aspect of chronic pain specifically the interference with functioning in for example work homework chores recreational and social activities due to pain
Nature and extent of the burden and risks associated with participation benefit and group relatedness Participation is not expected to have any risks Participants can quit the study at any moment and will not be excluded based on medication use or other current treatment for CIPN If participants regress during the intervention and need new chemotherapy treatment they can choose if they will continue or not Participants do need to invest time to follow the intervention which takes around 2 hours per week Furthermore it might be confronting to work on pain acceptance for participants Benefits of participation are foremost a possible improvement in pain interference and reductions in pain and CIPN symptoms
Objective The goal of this study is to examine the effectiveness of an online psychological intervention based on Acceptance and Commitment Therapy ACT in a Randomized Controlled Trial RCT and compared to a treatment-as-usual control condition TAU We aim to improve pain interference in cancer survivors with chronic painful CIPN present for at least 3 months in the curative disease phase who were treated with chemotherapy treatment at least 6 months ago irrespective of disease site
Study design It concerns a test of effectiveness of the ACT intervention in an RCT on quality of life In total 146 participants will be randomly allocated to one of two groups the online ACT intervention with therapist email guidance or a control condition that receives treatment-as-usual Patients in the control condition can follow the online ACT intervention directly after the 3 month-follow up measurement Self-reported questionnaires will be conducted at baseline after the intervention and at 3- and 6-month follow-up Additionally interviews will be executed with a subgroup of interested patients afterwards to explore intervention effects more in-depth Participants will be sampled via various patient organizations oncologists and advertisements distributed via the PROFILES-registry that contains ongoing research projects on CIPN Data will be collected online via the PROFILES-registry
Study population The population consists of adult cancer survivors in the curative disease phase suffering from painful CIPN for at least 3 months and who received chemotherapy treatment 6 or more months ago
Intervention An online ACT intervention was developed in the first phase of the QLIPP-CIPN study In this study phase insights into daily limitations and quality of life of the patient population were gained which served as the basis of the patient-centered development of the online ACT intervention following the CeHRes roadmap for participatory eHealth design The intervention includes an 8-week self-management course containing 6 modules regarding psycho-education and ACT- processes By means of text and exercises people learn to carry out value-oriented goals in daily life with pain To do this they learn new ways of coping with pain including reducing pain avoidance and increasing pain acceptance Additionally participants will receive email guidance
Main study parametersendpoint Pain interference in daily life using subscale Interference of the Multidimensional Pain Inventory MPI This scale focuses on a psychosocial aspect of chronic pain specifically the interference with functioning in for example work homework chores recreational and social activities due to pain
Nature and extent of the burden and risks associated with participation benefit and group relatedness Participation is not expected to have any risks Participants can quit the study at any moment and will not be excluded based on medication use or other current treatment for CIPN If participants regress during the intervention and need new chemotherapy treatment they can choose if they will continue or not Participants do need to invest time to follow the intervention which takes around 2 hours per week Furthermore it might be confronting to work on pain acceptance for participants Benefits of participation are foremost a possible improvement in pain interference and reductions in pain and CIPN symptoms
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None