Clinical trial NCT05371158: Effectiveness of Online ACT for Pain Interference in Cancer Survivors With Chronic Painful CIPN
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Cancer Survivors
Keywords: CIPN, cancer survivors, Acceptance and Commitment Therapy, eHealth, online, PROFILES registry
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Comprehensive Cancer Centre The Netherlands
First posted: 2022-05-12
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain interference
timeFrame: T0b (0 months)
measure: Pain interference
timeFrame: T1 (3 weeks)
measure: Pain interference
timeFrame: T2 (6 weeks)
measure: Pain interference
timeFrame: T3 (2 months)
measure: Pain interference
timeFrame: T4 (5 months)
measure: Pain interference
timeFrame: T5 (8 months)
Secondary outcomes:
measure: Cancer related quality of life
timeFrame: T0b (0 months)
measure: Cancer related quality of life
timeFrame: T3 (2 months)
measure: Cancer related quality of life
timeFrame: T4 (5 months)
measure: Cancer related quality of life
timeFrame: T5 (8 months)
measure: CIPN symptom severity
timeFrame: T0a (0 months)
measure: CIPN symptom severity
timeFrame: T3 (2 months),
measure: CIPN symptom severity
timeFrame: T4 (5 months)
measure: CIPN symptom severity
timeFrame: T5 (8 months)
measure: Pain intensity
timeFrame: T0a (0 months)
measure: Pain intensity
timeFrame: T3 (2 months)
measure: Pain intensity
timeFrame: T4 (5 months)
measure: Pain intensity
timeFrame: T5 (8 months)
measure: Pain catastrophizing
timeFrame: T0b (0 months)
measure: Pain catastrophizing
timeFrame: T1 (3 weeks)
measure: Pain catastrophizing
timeFrame: T2 (6 weeks)
measure: Pain catastrophizing
timeFrame: T3 (2 months)
measure: Pain catastrophizing
timeFrame: T4 (5 months)
measure: Pain catastrophizing
timeFrame: T5 (8 months)
measure: Psychological distress
timeFrame: T0b (0 months)
measure: Psychological distress
timeFrame: T1 (3 weeks)
measure: Psychological distress
timeFrame: T2 (6 weeks)
measure: Psychological distress
timeFrame: T3 (2 months)
measure: Psychological distress
timeFrame: T4 (5 months)
measure: Psychological distress
timeFrame: T5 (8 months)
measure: Psychological flexibility
timeFrame: T0a (0 months)
measure: Psychological flexibility
timeFrame: T1 (3 weeks)
measure: Psychological flexibility
timeFrame: T2 (6 weeks)
measure: Psychological flexibility
timeFrame: T3 (2 months)
measure: Psychological flexibility
timeFrame: T4 (5 months)
measure: Mindfulness
timeFrame: T0b (0 months)
measure: Mindfulness
timeFrame: T1 (3 weeks)
measure: Mindfulness
timeFrame: T2 (6 weeks)
measure: Mindfulness
timeFrame: T3 (2 months)
measure: Mindfulness
timeFrame: T4 (5 months)
measure: Mindfulness
timeFrame: T5 (8 months)
measure: Values-based living
timeFrame: T0b (0 months)
measure: Values-based living
timeFrame: T1 (3 weeks)
measure: Values-based living
timeFrame: T2 (6 weeks)
measure: Values-based living
timeFrame: T3 (2 months)
measure: Values-based living
timeFrame: T4 (5 months)
measure: Values-based living
timeFrame: T5 (8 months)
measure: Intervention evaluation (Based on: Trompetter et al. (2015)).
timeFrame: T3 (2 months) (ACT)
measure: Intervention evaluation (Based on: Trompetter et al. (2015)).
timeFrame: T5 (8 months) (WLC)
measure: Adherence
timeFrame: T5
Other outcomes:
measure: Interviews
timeFrame: T3 (2 months)
measure: Interviews
timeFrame: T5 (8 months)
Locations:
city: Tilburg
country: Netherlands
facility: Tilburg University
state: Noord-Brabant
Study officials:
affiliation: Tilburg University
name: Floortje Mols, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes, S. C., Strosahl, K., and Wilson, K. G. (2012) Acceptance & Commitment Therapy: The process and practice of mindful change 2nd. Guilford Press.
citation: 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.
citation: 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.