Effectiveness of Online ACT for Pain Interference in Cancer Survivors With Chronic Painful CIPN (QLIPP-CIPN)

Daniëlle van de Graaf

Status: Terminated

Conditions: Chemotherapy-induced Peripheral Neuropathy; Cancer Survivors

Treatments: Behavioral: Online intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05371158

12181

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Online intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Online intervention

Control condition

No Intervention group

Description:

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.