Effectiveness of Online ACT for Pain Interference in Cancer Survivors With Chronic Painful CIPN

NCT05371158 | Terminated

• 1 other identifier: 12181
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Cancer Survivors

Keywords

CIPN, cancer survivors, Acceptance and Commitment Therapy, eHealth, online, PROFILES registry

Outcome Measures

Primary Outcomes (6)

• Pain interference

  Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.

  T0b (0 months)

• Pain interference

  Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.

  T1 (3 weeks)

• Pain interference

  Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.

  T2 (6 weeks)

• Pain interference

  Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.

  T3 (2 months)

• Pain interference

  Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.

  T4 (5 months)

• Pain interference

  Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.

  T5 (8 months)

Secondary Outcomes (44)

• Cancer related quality of life

  T0b (0 months)

• Cancer related quality of life

  T3 (2 months)

• Cancer related quality of life

  T4 (5 months)

• Cancer related quality of life

  T5 (8 months)

• CIPN symptom severity

  T0a (0 months)

Other Outcomes (2)

• Interviews

  T3 (2 months)

• Interviews

  T5 (8 months)

Study Arms (2)

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.

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.

Interventions

Online intervention BEHAVIORAL

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.

Also known as: Embrace Pain

Online intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniëlle van de Graaf: lead
• Dutch Cancer Society: collaborator
• Comprehensive Cancer Centre The Netherlands: collaborator

Study Sites (1)

Tilburg University

Tilburg, North Brabant, 5037AB, Netherlands

Location

Related Publications (3)

• Hayes, S. C., Strosahl, K., and Wilson, K. G. (2012) Acceptance & Commitment Therapy: The process and practice of mindful change 2nd. Guilford Press.

  BACKGROUND

• 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.

  PMID: 35201353 BACKGROUND

• van 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.

  PMID: 35945582 DERIVED

Related Links

• Data security and data access

Study Officials

• Floortje Mols, PhD

  Tilburg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: May 12, 2022
• Study Start: December 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be stored in a secure location (PROFILES registry) for 15 years.
• Access Criteria: Raw data from the PROFILES registry is available for non-commercial scientific research, subject to study question, privacy, and confidentiality restrictions, and registration.

Locations

NL (1)