Chemotherapy-induced Peripheral NeuropathyQLIPP-CIPNNCT05371158
Effectiveness of Online ACT for Pain Interference in Cancer Survivors With Chronic Painful CIPN
A study testing Online intervention in people with Chemotherapy-induced Peripheral Neuropathy and Cancer Survivors, run by Daniëlle van de Graaf at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Cancer Survivors
- What is being tested?
- Online intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2021to 1 Jul 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of 18 years or older,
- identified by a clinician or self as having painful sensations (i.e., aching, burning, ''pins-and-needles'', shock-like, painful tingling, numbness, cramps) bilaterally in the feet/legs and/or hands/arms for at least 3 months. Furthermore,
- score a 3 or higher on an 11-point pain intensity scale (Numeric Rating Scale),
- the pain was not present prior to receiving chemotherapy,
- chemotherapy ended at least 6 months ago.
Who cannot join
- enrollment in psychological treatment related to cancer, pain, or psychiatry upon entry,
- new chemotherapy scheduled during study participation,
- no access to the Internet/no email address,
- not enough time to follow the intervention (2 hours per week),
- problems with the Dutch language.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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 parameters/endpoint: 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.
- Being tested
- Online intervention
- Keywords
- CIPN, cancer survivors, Acceptance and Commitment Therapy, eHealth, online, PROFILES registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online interventionBehavioural
Also called Embrace Pain
The first module includes psychoeducation on neuropathic pain and CIPN (Table 1). Participants acquaintance themselves with intervention goals and mindfulness exercises central to ACT. In subsequent modules, participants learn about the aversive effects of pain avoidance, gain insight into their personal values, and work on pain acceptance. Participants exercise to recognize unhelpful thoughts about their pain and learn the difference between the subjective (judging) and objective self, and think about concrete actions to prevent relapse. The intervention primarily consists of text and experiential exercises, complemented with illustrations, metaphors and audio (mp3) files. Additional functionalities may be an outline of experiences by other CIPN patients and/or the ability to keep a diary. Participants in the experimental condition will receive therapist guidance.
| Study group | Role | What they receive |
|---|---|---|
| Online intervention | Experimental | The experimental condition includes an online psychological intervention with therapist email guidance based on Acceptance \& Commitment Therapy (ACT). ACT is a form of Cognitive Behavioral Therapy, which focuses on acceptance of chronic pain in order to be able to perform valuable activities, instead of attempts of avoidance and controlling (Hayes et al., 2012). The main goal of ACT is increasing psychological flexibility, which includes the ability to act effectively according to personal values, with pain. ACT can thereby play a role in creating more realistic expectations regarding expectations of future pain relief. The intervention can be worked through in the participant's own living environment. It consists of 6 modules which can be worked through in 8 weeks. Receives: Behavioral: Online intervention |
| Control condition | No intervention | The control condition includes a waiting list group that can receive treatment-as-usual. Participants are placed on a waiting list and receive the online psychological ACT intervention without email guidance directly after the first follow-up measurement. Participants placed on the waiting list will not receive the ACT intervention immediately. Participants do have the opportunity to access treatment as usual (TAU). Directly after the first, 3-month follow-up measurement these participants receive the opportunity to follow the intervention without email guidance by a therapist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T0b (0 months)
Pain interference
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T1 (3 weeks)
Pain interference
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T2 (6 weeks)
Pain interference
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T3 (2 months)
Pain interference
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T4 (5 months)
Pain interference
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T5 (8 months)
Secondary outcomes (44)
Cancer related quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). Minimum = 30, maximum = 126. Higher score means better outcome.
Measured: T0b (0 months)
Cancer related quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). Minimum = 30, maximum = 126. Higher score means better outcome.
Measured: T3 (2 months)
Cancer related quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). Minimum = 30, maximum = 126. Higher score means better outcome.
Measured: T4 (5 months)
Cancer related quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). Minimum = 30, maximum = 126. Higher score means better outcome.
Measured: T5 (8 months)
CIPN symptom severity
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN20 (EORTC QLQ-CIPN20). Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T0a (0 months)
CIPN symptom severity
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN20 (EORTC QLQ-CIPN20). Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T3 (2 months),
CIPN symptom severity
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN20 (EORTC QLQ-CIPN20). Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T4 (5 months)
CIPN symptom severity
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN20 (EORTC QLQ-CIPN20). Minimum = 0, maximum = 60. Higher score means worse outcome.
Measured: T5 (8 months)
Pain intensity
Numeric Rating Scale (NRS-11). Minimum = 0, maximum = 20. Higher score means worse outcome.
Measured: T0a (0 months)
Pain intensity
Numeric Rating Scale (NRS-11). Minimum = 0, maximum = 20. Higher score means worse outcome.
Measured: T3 (2 months)
Pain intensity
Numeric Rating Scale (NRS-11). Minimum = 0, maximum = 20. Higher score means worse outcome.
Measured: T4 (5 months)
Pain intensity
Numeric Rating Scale (NRS-11). Minimum = 0, maximum = 20. Higher score means worse outcome.
Measured: T5 (8 months)
Pain catastrophizing
Pain Catastrophizing Scale (PCS). Minimum = 0, maximum = 65. Higher score means worse outcome.
Measured: T0b (0 months)
Pain catastrophizing
Pain Catastrophizing Scale (PCS). Minimum = 0, maximum = 65. Higher score means worse outcome.
Measured: T1 (3 weeks)
Pain catastrophizing
Pain Catastrophizing Scale (PCS). Minimum = 0, maximum = 65. Higher score means worse outcome.
Measured: T2 (6 weeks)
Pain catastrophizing
Pain Catastrophizing Scale (PCS). Minimum = 0, maximum = 65. Higher score means worse outcome.
Measured: T3 (2 months)
Pain catastrophizing
Pain Catastrophizing Scale (PCS). Minimum = 0, maximum = 65. Higher score means worse outcome.
Measured: T4 (5 months)
Pain catastrophizing
Pain Catastrophizing Scale (PCS). Minimum = 0, maximum = 65. Higher score means worse outcome.
Measured: T5 (8 months)
Psychological distress
Hospital Anxiety and Depression Scale (HADS). Minimum = 0, maximum = 56. Higher score means worse outcome.
Measured: T0b (0 months)
Psychological distress
Hospital Anxiety and Depression Scale (HADS). Minimum = 0, maximum = 56. Higher score means worse outcome.
Measured: T1 (3 weeks)
Psychological distress
Hospital Anxiety and Depression Scale (HADS). Minimum = 0, maximum = 56. Higher score means worse outcome.
Measured: T2 (6 weeks)
Psychological distress
Hospital Anxiety and Depression Scale (HADS). Minimum = 0, maximum = 56. Higher score means worse outcome.
Measured: T3 (2 months)
Psychological distress
Hospital Anxiety and Depression Scale (HADS). Minimum = 0, maximum = 56. Higher score means worse outcome.
Measured: T4 (5 months)
Psychological distress
Hospital Anxiety and Depression Scale (HADS). Minimum = 0, maximum = 56. Higher score means worse outcome.
Measured: T5 (8 months)
Psychological flexibility
Psychological Inflexibility in Pain Scale (PIPS). Minimum = 0, maximum = 84. Higher score means worse outcome (higher score means more inflexibility).
Measured: T0a (0 months)
Psychological flexibility
Psychological Inflexibility in Pain Scale (PIPS). Minimum = 0, maximum = 84. Higher score means worse outcome (higher score means more inflexibility).
Measured: T1 (3 weeks)
Psychological flexibility
Psychological Inflexibility in Pain Scale (PIPS). Minimum = 0, maximum = 84. Higher score means worse outcome (higher score means more inflexibility).
Measured: T2 (6 weeks)
Psychological flexibility
Psychological Inflexibility in Pain Scale (PIPS). Minimum = 0, maximum = 84. Higher score means worse outcome (higher score means more inflexibility).
Measured: T3 (2 months)
Psychological flexibility
Psychological Inflexibility in Pain Scale (PIPS). Minimum = 0, maximum = 84. Higher score means worse outcome (higher score means more inflexibility).
Measured: T4 (5 months)
Mindfulness
Freiburg Mindfulness Inventory (FMI). Minimum = 0, maximum = 56. Higher score means better outcome.
Measured: T0b (0 months)
Mindfulness
Freiburg Mindfulness Inventory (FMI). Minimum = 0, maximum = 56. Higher score means better outcome.
Measured: T1 (3 weeks)
Mindfulness
Freiburg Mindfulness Inventory (FMI). Minimum = 0, maximum = 56. Higher score means better outcome.
Measured: T2 (6 weeks)
Mindfulness
Freiburg Mindfulness Inventory (FMI). Minimum = 0, maximum = 56. Higher score means better outcome.
Measured: T3 (2 months)
Mindfulness
Freiburg Mindfulness Inventory (FMI). Minimum = 0, maximum = 56. Higher score means better outcome.
Measured: T4 (5 months)
Mindfulness
Freiburg Mindfulness Inventory (FMI). Minimum = 0, maximum = 56. Higher score means better outcome.
Measured: T5 (8 months)
Values-based living
Engaged Living Scale (ELS). Minimum = 0, maximum = 80. Higher score means better outcome.
Measured: T0b (0 months)
Values-based living
Engaged Living Scale (ELS). Minimum = 0, maximum = 80. Higher score means better outcome.
Measured: T1 (3 weeks)
Values-based living
Engaged Living Scale (ELS). Minimum = 0, maximum = 80. Higher score means better outcome.
Measured: T2 (6 weeks)
Values-based living
Engaged Living Scale (ELS). Minimum = 0, maximum = 80. Higher score means better outcome.
Measured: T3 (2 months)
Values-based living
Engaged Living Scale (ELS). Minimum = 0, maximum = 80. Higher score means better outcome.
Measured: T4 (5 months)
Values-based living
Engaged Living Scale (ELS). Minimum = 0, maximum = 80. Higher score means better outcome.
Measured: T5 (8 months)
Intervention evaluation (Based on: Trompetter et al. (2015)).
Questions:
- During the past few weeks, how many hours did you spend on average per week working on the online course?
- On average, how many days per week did you do mindfulness exercises during the past few weeks?
- On the days you practiced mindfulness: On average, how many minutes did you spend practicing?
- How do you rate the quality of the online training you received?
- Did you receive the kind of help you were hoping to receive?
- To what extent did the online training meet your needs?
- Suppose one of your acquaintances needed the same help, would you recommend the online training?
- How satisfied are you with the amount of help you received?
- Did the online training help you cope better with your problems?
- Overall, how satisfied are you with the online training you received?
- Would you do the online training again if you needed to?
- What grade would you give the online training?
Measured: T3 (2 months) (ACT)
Intervention evaluation (Based on: Trompetter et al. (2015)).
Questions:
- During the past few weeks, how many hours did you spend on average per week working on the online course?
- On average, how many days per week did you do mindfulness exercises during the past few weeks?
- On the days you practiced mindfulness: On average, how many minutes did you spend practicing?
- How do you rate the quality of the online training you received?
- Did you receive the kind of help you were hoping to receive?
- To what extent did the online training meet your needs?
- Suppose one of your acquaintances needed the same help, would you recommend the online training?
- How satisfied are you with the amount of help you received?
- Did the online training help you cope better with your problems?
- Overall, how satisfied are you with the online training you received?
- Would you do the online training again if you needed to?
- What grade would you give the online training?
Measured: T5 (8 months) (WLC)
Adherence
Adherence will be based on technical data obtained from Karify's online environment. The following information will be used for this purpose.
- Sent messages: the moment when a message is sent to the supervisor.
- Given feedback: the moment when feedback is given on a specific assignment.
- Significant moment: first_viewed: the moment when an assignment is viewed for the first time.
- Significant moment: finished: the moment when an assignment is handed in for the first time.
This will possibly be combined with the number of hours spent on intervention (self-reported), as described under 'intervention evaluation'.
Measured: T5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Dec 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Why it stopped: The trial was terminated early due to low participant enrollment. Over a period of 22 months, a total of 112 patients were recruited, with 57 randomly assigned to the ACT group and 55 to the WLC group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniëlle van de Graaf
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands
- Responsible party
- Sponsor-investigator, Daniëlle van de Graaf, Tilburg University
- Investigators
- Floortje Mols, PhD, Principal investigator, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371158
- Sponsor's protocol ID
- 12181
- Acronym
- QLIPP-CIPN
- Status last verified
- Aug 2025
- First submitted
- 16 Mar 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PROFILES data is freely available (FAIR principles) for non-commercial scientific research trough www.profilesregistry.nl.
Publications
Hayes, S. C., Strosahl, K., and Wilson, K. G. (2012) Acceptance & Commitment Therapy: The process and practice of mindful change 2nd. Guilford Press.
van de Poll-Franse LV, Horevoorts N, Schoormans D, Beijer S, Ezendam NPM, Husson O, Oerlemans S, Schagen SB, Hageman GJ, Van Deun K, van den Hurk C, van Eenbergen M, Mols F; PROFILES Registry Group. Measuring Clinical, Biological, and Behavioral Variables to Elucidate Trajectories of Patient-Reported Outcomes: The PROFILES Registry. J Natl Cancer Inst. 2022 Jun 13;114(6):800-807. doi: 10.1093/jnci/djac047.
PubMed 35201353van de Graaf DL, Mols F, Trompetter HR, van der Lee ML, Schreurs KMG, Borosund E, Nes LS, Smeets T. Effectiveness of the online Acceptance and Commitment Therapy intervention "Embrace Pain" for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial. Trials. 2022 Aug 9;23(1):642. doi: 10.1186/s13063-022-06592-3.
PubMed 35945582
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05371158
- Acronym / sponsor ID
- QLIPP-CIPN / 12181
- Keywords
- CIPN, cancer survivors, Acceptance and Commitment Therapy, eHealth, online, PROFILES registry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated early due to low participant enrollment. Over a period of 22 months, a total of 112 patients were recruited, with 57 randomly assigned to the ACT group and 55 to the WLC group.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Daniëlle van de GraafUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 12 May 2022 (actual)
- 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.
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 parameters/endpoint: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online intervention | Experimental | Behavioral: Online interventionThe experimental condition includes an online psychological intervention with therapist email guidance based on Acceptance \& Commitment Therapy (ACT). ACT is a form of Cognitive Behavioral Therapy, which focuses on acceptance of chronic pain in order to be able to perform valuable activities, instead of attempts of avoidance and controlling (Hayes et al., 2012). The main goal of ACT is increasing psychological flexibility, which includes the ability to act effectively according to personal values, with pain. ACT can thereby play a role in creating more realistic expectations regarding expectations of future pain relief. The intervention can be worked through in the participant's own living environment. It consists of 6 modules which can be worked through in 8 weeks. |
| Control condition | No intervention | –The control condition includes a waiting list group that can receive treatment-as-usual. Participants are placed on a waiting list and receive the online psychological ACT intervention without email guidance directly after the first follow-up measurement. Participants placed on the waiting list will not receive the ACT intervention immediately. Participants do have the opportunity to access treatment as usual (TAU). Directly after the first, 3-month follow-up measurement these participants receive the opportunity to follow the intervention without email guidance by a therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age of 18 years or older,
- identified by a clinician or self as having painful sensations (i.e., aching, burning, ''pins-and-needles'', shock-like, painful tingling, numbness, cramps) bilaterally in the feet/legs and/or hands/arms for at least 3 months. Furthermore,
- score a 3 or higher on an 11-point pain intensity scale (Numeric Rating Scale),
- the pain was not present prior to receiving chemotherapy,
- chemotherapy ended at least 6 months ago.
Key exclusion criteria (5 listed)
- enrollment in psychological treatment related to cancer, pain, or psychiatry upon entry,
- new chemotherapy scheduled during study participation,
- no access to the Internet/no email address,
- not enough time to follow the intervention (2 hours per week),
- problems with the Dutch language.
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 |
|---|---|---|
| Online interventionAlso: Embrace PainThe first module includes psychoeducation on neuropathic pain and CIPN (Table 1). Participants acquaintance themselves with intervention goals and mindfulness exercises central to ACT. In subsequent modules, participants learn about the aversive effects of pain avoidance, gain insight into their personal values, and work on pain acceptance. Participants exercise to recognize unhelpful thoughts about their pain and learn the difference between the subjective (judging) and objective self, and think about concrete actions to prevent relapse. The intervention primarily consists of text and experiential exercises, complemented with illustrations, metaphors and audio (mp3) files. Additional functionalities may be an outline of experiences by other CIPN patients and/or the ability to keep a diary. Participants in the experimental condition will receive therapist guidance. | Behavioural | Online intervention |
Primary outcome
Pain interference
Time frame: T0b (0 months)
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Pain interference
Time frame: T1 (3 weeks)
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Pain interference
Time frame: T2 (6 weeks)
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Pain interference
Time frame: T3 (2 months)
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Pain interference
Time frame: T4 (5 months)
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
Pain interference
Time frame: T5 (8 months)
Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.
44 secondary outcomes
Cancer related quality of life
Time frame: T0b (0 months)
Cancer related quality of life
Time frame: T3 (2 months)
Cancer related quality of life
Time frame: T4 (5 months)
Cancer related quality of life
Time frame: T5 (8 months)
CIPN symptom severity
Time frame: T0a (0 months)
CIPN symptom severity
Time frame: T3 (2 months),
CIPN symptom severity
Time frame: T4 (5 months)
CIPN symptom severity
Time frame: T5 (8 months)
Pain intensity
Time frame: T0a (0 months)
Pain intensity
Time frame: T3 (2 months)
Pain intensity
Time frame: T4 (5 months)
Pain intensity
Time frame: T5 (8 months)
Pain catastrophizing
Time frame: T0b (0 months)
Pain catastrophizing
Time frame: T1 (3 weeks)
Pain catastrophizing
Time frame: T2 (6 weeks)
Pain catastrophizing
Time frame: T3 (2 months)
Pain catastrophizing
Time frame: T4 (5 months)
Pain catastrophizing
Time frame: T5 (8 months)
Psychological distress
Time frame: T0b (0 months)
Psychological distress
Time frame: T1 (3 weeks)
Psychological distress
Time frame: T2 (6 weeks)
Psychological distress
Time frame: T3 (2 months)
Psychological distress
Time frame: T4 (5 months)
Psychological distress
Time frame: T5 (8 months)
Psychological flexibility
Time frame: T0a (0 months)
Psychological flexibility
Time frame: T1 (3 weeks)
Psychological flexibility
Time frame: T2 (6 weeks)
Psychological flexibility
Time frame: T3 (2 months)
Psychological flexibility
Time frame: T4 (5 months)
Mindfulness
Time frame: T0b (0 months)
Mindfulness
Time frame: T1 (3 weeks)
Mindfulness
Time frame: T2 (6 weeks)
Mindfulness
Time frame: T3 (2 months)
Mindfulness
Time frame: T4 (5 months)
Mindfulness
Time frame: T5 (8 months)
Values-based living
Time frame: T0b (0 months)
Values-based living
Time frame: T1 (3 weeks)
Values-based living
Time frame: T2 (6 weeks)
Values-based living
Time frame: T3 (2 months)
Values-based living
Time frame: T4 (5 months)
Results and safety
The study was stopped early (reason given: The trial was terminated early due to low participant enrollment. Over a period of 22 months, a total of 112 patients were recruited, with 57 randomly assigned to the ACT group and 55 to the WLC group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- BackgroundHayes, S. C., Strosahl, K., and Wilson, K. G. (2012) Acceptance & Commitment Therapy: The process and practice of mindful change 2nd. Guilford Press.
- Background: PubMed 35201353van de Poll-Franse LV, Horevoorts N, Schoormans D, Beijer S, Ezendam NPM, Husson O, Oerlemans S, Schagen SB, Hageman GJ, Van Deun K, van den Hurk C, van Eenbergen M, Mols F; PROFILES Registry Group. Measuring Clinical, Biological, and Behavioral Variables to Elucidate Trajectories of Patient-Reported Outcomes: The PROFILES Registry. J Natl Cancer Inst. 2022 Jun 13;114(6):800-807. doi: 10.1093/jnci/djac047.
- Derived from this study: PubMed 35945582van de Graaf DL, Mols F, Trompetter HR, van der Lee ML, Schreurs KMG, Borosund E, Nes LS, Smeets T. Effectiveness of the online Acceptance and Commitment Therapy intervention "Embrace Pain" for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial. Trials. 2022 Aug 9;23(1):642. doi: 10.1186/s13063-022-06592-3.
- Data security and data accessLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. PROFILES data is freely available (FAIR principles) for non-commercial scientific research trough www.profilesregistry.nl.
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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.
Floortje Mols, PhD principal investigator
Tilburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online intervention in people with Chemotherapy-induced Peripheral Neuropathy and Cancer Survivors, run by Daniëlle van de Graaf at 1 site in Netherlands.
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 5 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: stopped early, as of the sponsor's last update on 15 Aug 2025. 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 Netherlands. 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 was stopped early (reason given: The trial was terminated early due to low participant enrollment. Over a period of 22 months, a total of 112 patients were recruited, with 57 randomly assigned to the ACT group and 55 to the WLC group.). Results are not available in the source record.
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?
Pain interference (time frame: T0b (0 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371158, which also lists 3 linked publications.
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 15 Aug 2025.