A clinical trial of group-based body psychotherapy to improve bodily disturbances in post-treatment cancer patients in combination with randomized controlled smartphone-triggered bodily interventions (KPTK): study protocol

Abstract

BackgroundDisturbances in bodily well-being represent one key source of suffering and impairment related to cancer. There is growing evidence that body psychotherapy (BPT) is efficacious for the treatment of various mental disorders. However, with regard to cancer patients, evidence is scarce. The aims of this project are to evaluate whether bodily disturbances in post-treatment cancer patients can be improved by group BPT, and to estimate the efficacy of intermittent smartphone-triggered bodily interventions.MethodsThe project is a bi-center study with two participating centers in Switzerland, applying a pre-post convergent parallel design of a weekly group BPT using a waiting-period comparator, including a nested RCT during the group BPT phase. During the BPT phase, either a smartphone-triggered bodily intervention or a smartphone-triggered control intervention is provided at random over 5 consecutive weeks, on 6 days weekly. Patients who had received curatively intended treatment for any malignant neoplasm (treatment being completed ≥3 months) and are suffering from bodily disturbances are screened to assess eligibility. Sample size estimation is based on an a priori power analysis. We plan to include a total of N = 88 subjects, aiming at at least 52 completers.Patients are surveyed three times (baseline assessment (T0), pre- (T1) and post-intervention assessment (T2)), and on a daily basis along BPT during five consecutive weeks. The primary outcome, bodily disturbances, is assessed using the ‘Body Image Scale‘(BIS). For the secondary outcomes standardized questionnaires are used to assess changes in experience of presence and vitality, mood, body mindfulness, somatic symptoms and somatic symptom disorder, quality of life, anxiety, and depression including suicidal tendency, vitality and mental health, as well as group cohesion. Using semi standardized interviews (at T0 and T2), we aim to explore the relation of BPT with bodily disturbances and body image in post-treatment cancer patients, as well as the acceptance and burden of the intervention.DiscussionThe proposed study has strong potential benefits for cancer patients, as it may pave the way for new therapeutic approaches to treat bodily disturbances, which persist despite curative tumor therapy. These may considerably improve patients’ biopsychosocial well-being and quality of life.Trial registrationClinicalTrials.gov NCT03707548 (registered 9 October 2018; retrospectively registered).

Group-based body psychotherapy improves appreciation of body awareness in post-treatment cancer patients: A non-randomized clinical trial

“…The study protocol of this trial, including methodological details, is published elsewhere ( Grossert et al, 2019 ). We conducted this bi-center study, by applying a pre-post convergent parallel design of weekly group BPT interspersed with smartphone-based ambulatory interventions using a waiting-period comparator.…”

“…The manualized group BPT was carried out in small groups (range of 5–7 patients) and was provided by trained psychotherapists. For a detailed tabulated description of the intervention, we kindly refer to Grossert and colleagues ( Grossert et al, 2019 #1361). The 6 group BPT sessions covered the following topics: The first session included a (1) general introduction, promoting group cohesion and focusing on body awareness; the second session (2) focused on physical resources and grounding, whereas the third session (3) had the focus on regulating closeness and distance.…”

Smartphone-Based Psychotherapeutic Interventions in Blended Care of Cancer Survivors: Nested Randomized Clinical Trial

“…All participants signed an informed consent before study participation. We kindly refer to a previous publication [ 15 ] for more information regarding the larger nonrandomized trial.…”

“…Exclusion criteria for the entire nonrandomized study were (1) sign of progress or recurrence of malignancy at study inclusion, (2) having a severe current mental disorder, (3) risk of current suicidality, (4) participation in any other clinical trial with a psychosocial intervention, (5) receiving other current psychotherapeutic treatment for less than 6 months (with the exception of already existing therapies lasting ≥6 months), and (6) inability to understand and speak German. All eligibility criteria are described in detail in the study protocol [ 15 ]. Patients were recruited at the study centers; additionally, they were approached via public advertisements.…”

“…The smartphone-based bodily intervention offered audio clips consisting of BPT tools, experiences, and strategies that reflected the content of the face-to-face sessions. For more details on the contents of these bodily interventions, please refer to Multimedia Appendix 1 [ 7 , 15 , 17 - 19 ] or the entire study protocol [ 15 ]. The unspecific comparator interventions consisted of 15 selected Grimms’ fairy tales.…”