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

TerminatedNot applicableNCT05371158

View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

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
Conditions: Chemotherapy-induced Peripheral Neuropathy
Cancer Survivors
Interventions: Behavioral: Online intervention
Sponsor: Daniëlle van de Graaf
Collaborators: Dutch Cancer Society; Comprehensive Cancer Centre The Netherlands
Organization: Tilburg University
Start date: 2021-12-01
Primary completion: 2024-07-01
Sex: All
Age range: from 18 Years
Results posted: No results posted in this snapshot
Countries: Netherlands
Total sites listed: 1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

Inclusion criteria: 1. age of 18 years or older, 2. 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, 3. score a 3 or higher on an 11-point pain intensity scale (Numeric Rating Scale), 4. the pain was not present prior to receiving chemotherapy, 5. chemotherapy ended at least 6 months ago. Exclusion criteria: 1. enrollment in psychological treatment related to cancer, pain, or psychiatry upon entry, 2. new chemotherapy scheduled during study participation, 3. no access to the Internet/no email address, 4. not enough time to follow the intervention (2 hours per week), 5. problems with the Dutch language.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05371158