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…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain interference in daily life: Multidimensional Pain Inventory (MPI) -
subscale Interference.
Secondary outcome
Pain intensity: 11-point Numeric Rating Scale (NRS), Psychological distress:
Hospital Anxiety and Depression Scale (HADS), Quality of life: EORTC QLQ-C30,
CIPN symptom severity: EORTC QLQ - CIPN20 , Psychological flexibility:
Psychological Inflexibility in Pain Scale (PIPS), Freiburg Mindfulness
Inventory (FMI-NL), Values-based Living: Engaged Living Scale (ELS), Pain
Catastrophizing: Pain Catastrophizing Scale (PCS ).
Background summary
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.
Study 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 persistent 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 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.
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.
Study burden and risks
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.
Warandelaan 2
Tilburg 5037AB
NL
Warandelaan 2
Tilburg 5037AB
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Cancer patient or survivor
- Chemotherapy ended at least 6 months ago
- Identified by a clinician/self as having painful sensations bilaterally in
the feet/legs and/or hands for at least 3 months. Neuropathic pain may present
as aching, burning, **pins-and-needles,** and/or shock-like, and also covers
painful tingling, numbness and/or cramps.
- Scoring a 4 or higher on an 11-point Numeric Rating Scale (NRS).
- Pain was not present prior to receiving chemotherapy but related temporally
to the initiation of chemotherapy.
Exclusion criteria
- New chemotherapy scheduled during study involvement
- Very low scores on psychological inflexibility (PIPS; more than 1 SD below
mean of population of chronic pain patients in pain rehabilitation centers.
These participants already scored highly beneficial on the expected working
mechanism of treatment which will lead to ceiling effects)
- No access to the Internet at home/no email address
- Not enough time to follow the intervention (2hours per week)
- Problems with Dutch language
- Enrollment in cancer, pain, or psychiatric related treatment upon entry
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78436.028.21 |