NCT05371158: QLIPP-CIPN

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

Terminated NA Last updated 15 August 2025

What this trial tests

NA trial testing Online intervention in Chemotherapy-induced Peripheral Neuropathy in 112 participants. Terminated before completion.

Timeline

1 December 2021

Primary endpoint
1 July 2024

1 July 2024

Quick facts

Lead sponsor	Daniëlle van de Graaf
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	112
Start date	1 December 2021
Primary completion	1 July 2024
Estimated completion	1 July 2024
Sites	1 location across Netherlands

Drugs / interventions tested

• Online intervention

Conditions studied

• Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →
• Cancer Survivors — all drugs for Cancer Survivors →

Sponsor

Daniëlle van de Graaf

Who can join

18 and older, any sex, with Chemotherapy-induced Peripheral Neuropathy or Cancer Survivors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   van de Graaf DL, Mols F, Trompetter HR, van der Lee ML, et al · · 2022 · cited 7× · PMID 35945582 · DOI 10.1186/s13063-022-06592-3