TY - JOUR
T1 - Effectiveness of the online Acceptance and Commitment Therapy intervention “Embrace Pain” for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy
T2 - study protocol for a randomized controlled trial
AU - van de Graaf, Daniëlle L.
AU - Mols, Floortje
AU - Trompetter, Hester R.
AU - van der Lee, Marije L.
AU - Schreurs, Karlein M.G.
AU - Børøsund, Elin
AU - Solberg Nes, Lise
AU - Smeets, Tom
N1 - Funding Information:
This study was supported by the Dutch Cancer Society (#12181), 00 31 20 - 570 04 50, [email protected]. The Dutch Cancer Society had no role in the study design, writing of the manuscript, or submission. Tilburg University is the sponsor of this study.
Funding Information:
We would like to thank two patient groups who served as advisors at this project, namely Olijf (Network for Women with Gynecologic Cancer) and BVN (Dutch Breast Cancer Society). Both patient advisory groups provided feedback on the project proposal.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: About 30% of cancer survivors suffer from chemotherapy-induced peripheral neuropathy (CIPN) ≥6 months after completion of chemotherapy. This condition, for which treatment options are scarce, comes with limitations in daily life functioning and decreased quality of life. The current study examines the effectiveness of an online self-help intervention based on Acceptance and Commitment Therapy (ACT) in comparison to a waiting list condition (WLC) to deal with CIPN. In addition, it examines which factors moderate effects and to what extent the effects differ between guided and unguided ACT intervention. Methods: A two-parallel, non-blinded randomized controlled trial (RCT) will be carried out. Adult cancer survivors who experience painful CIPN for at least 3 months and completed chemotherapy at least 6 months ago will be recruited (n=146). In the intervention condition, participants will follow an 8-week self-management course containing 6 modules regarding psychoeducation and ACT processes, including therapeutic email guidance. By means of text and experiential exercises, supplemented with illustrations, metaphors, and audio files, people will learn to carry out value-oriented activities in their daily life with pain. Participants will learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Participants in the WLC will be invited to follow the intervention without therapeutic guidance 5 months after start. Pain interference is the primary outcome, while psychological distress, quality of life, CIPN symptom severity, pain intensity, psychological flexibility, mindfulness skills, values-based living, and pain catastrophizing will serve as secondary outcomes. All outcome measures will be evaluated at inclusion and baseline, early-intervention, mid-intervention, post-treatment, and 3- and 6-month post-treatment. Qualitative interviews will be conducted post-treatment regarding experiences, usage, usability, content fit, and satisfaction with the intervention. Discussion: This study will provide valuable information on the effectiveness of an online self-help intervention based on ACT versus WLC for chronic painful CIPN patients. Trial registration: ClinicalTrials.gov NCT05371158. Registered on May 12, 2022. Protocol version: version 1, 24-05-2022
AB - Background: About 30% of cancer survivors suffer from chemotherapy-induced peripheral neuropathy (CIPN) ≥6 months after completion of chemotherapy. This condition, for which treatment options are scarce, comes with limitations in daily life functioning and decreased quality of life. The current study examines the effectiveness of an online self-help intervention based on Acceptance and Commitment Therapy (ACT) in comparison to a waiting list condition (WLC) to deal with CIPN. In addition, it examines which factors moderate effects and to what extent the effects differ between guided and unguided ACT intervention. Methods: A two-parallel, non-blinded randomized controlled trial (RCT) will be carried out. Adult cancer survivors who experience painful CIPN for at least 3 months and completed chemotherapy at least 6 months ago will be recruited (n=146). In the intervention condition, participants will follow an 8-week self-management course containing 6 modules regarding psychoeducation and ACT processes, including therapeutic email guidance. By means of text and experiential exercises, supplemented with illustrations, metaphors, and audio files, people will learn to carry out value-oriented activities in their daily life with pain. Participants will learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Participants in the WLC will be invited to follow the intervention without therapeutic guidance 5 months after start. Pain interference is the primary outcome, while psychological distress, quality of life, CIPN symptom severity, pain intensity, psychological flexibility, mindfulness skills, values-based living, and pain catastrophizing will serve as secondary outcomes. All outcome measures will be evaluated at inclusion and baseline, early-intervention, mid-intervention, post-treatment, and 3- and 6-month post-treatment. Qualitative interviews will be conducted post-treatment regarding experiences, usage, usability, content fit, and satisfaction with the intervention. Discussion: This study will provide valuable information on the effectiveness of an online self-help intervention based on ACT versus WLC for chronic painful CIPN patients. Trial registration: ClinicalTrials.gov NCT05371158. Registered on May 12, 2022. Protocol version: version 1, 24-05-2022
KW - Acceptance and Commitment Therapy
KW - Cancer survivors
KW - CIPN
KW - eHealth
KW - Online
KW - PROFILES registry
UR - http://www.scopus.com/inward/record.url?scp=85135728764&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06592-3
DO - 10.1186/s13063-022-06592-3
M3 - Article
C2 - 35945582
AN - SCOPUS:85135728764
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 642
ER -
