Clinical trial NCT03707548: BPT to Improve Bodily Disturbances in Post-treatment Cancer Patients
Official title: A Clinical Trial of Group-based Body Psychotherapy (BPT) to Improve Bodily Disturbances in Post-treatment Cancer Patients in Combination With Randomized Controlled Smartphone-triggered Bodily Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients
Keywords: body psychotherapy
smartphone-triggered interventions
psychosocial impairments related to cancer
cancer-related disturbances in bodily wellbeing
Body Image Scale
group psychotherapy
bodily disturbances in post-treatment cancer patients
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study design: The project follows the outline of a non-randomized evaluation of a weekly group BPT using a waiting-period comparator, with a nested randomized controlled trial (RCT) to evaluate the short-term efficacy of smartphone-triggered bodily interventions.

Measurement points:

* Patients will be surveyed at three points in time (initial consultation, pre- and post-intervention) to explore the effects of BPT on bodily disturbances and body image in post-treatment cancer patients.
* During the BPT Intervention group cohesion and bodily well-being will be assessed weekly.
* The smartphone-triggered bodily and control interventions will be provided over a period of 5 consecutive weeks on 6 days per week and will be assessed pre- and post intervention.
Primary purpose: TREATMENT

Brief summary: With this project investigators focus on the evaluation whether bodily disturbances in post-treatment cancer patients can be influenced positively by group BPT and if intermittent smartphone-triggered bodily interventions are effective.

Detailed description: Background: Disturbances in bodily wellbeing represent one key aspect of psychosocial impairments related to cancer. Therefore, interventions to improve bodily wellbeing in post-treatment cancer patients are important.

Objectives: This project aims at two goals:

1. Investigators want to evaluate whether bodily disturbances in post-treatment cancer patients can be influenced positively by group BPT (Non-randomized evaluation of a weekly group BPT using a waiting-period comparator).
2. In addition the efficacy of intermittent smartphone-triggered bodily interventions is assessed with a nested RCT to evaluate short-term efficacy of smartphone-triggered bodily interventions.

Study design: The project follows the outline of a non-randomized evaluation of a weekly group BPT using a waiting-period comparator, with a nested randomized controlled trial (RCT) to evaluate the short-term efficacy of smartphone-triggered bodily interventions.

Study flow:

* Participants will first undergo a waiting period (duration at least 6 weeks) followed by the group BPT (6 weekly sessions, 90 minutes each).
* During the group BPT, either a smartphone-triggered bodily intervention or a smartphone-triggered control intervention will be provided at random (randomization on a daily basis) over a period of 5 consecutive weeks on 6 days per week. This will result in 15 smartphone-triggered bodily interventions and 15 smartphone-triggered control interventions, which each patient will undergo.

Measurement points: Patients will be surveyed at three points in time (initial consultation, pre- and post-intervention). Standardized questionnaires will be used to measure patients' body disturbances, body image, body mindfulness, physical complaints, quality of life, vitality, mental health, anxiety and depression and to explore the effects of BPT on bodily disturbances and body image in post-treatment cancer patients.

Eligibility criteria: Inclusion Criteria:

* Having received curatively intended treatment for any malignant neoplasm; primary treatment (surgery, radiotherapy, chemotherapy) being completed \>/= 3 months ago before study inclusion. Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)
* existing bodily disturbances
* No sign of progress or recurrence of malignancy at study inclusion according to treating physician
* Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score
* Having an anticipated life expectancy of \>/= 12 months, according to treating physician
* age 18 years or older
* Capacity to participate in group BPT sessions in Basel or Winterthur, 3 study assessments, and the smartphone-triggered interventions
* Ability to provide informed consent

Exclusion Criteria:

* Suffering from a severe current mental disorder
* Risk of current suicidality, as indicated by a suicide item score \>/= 2 in the BDI-II (Beck Depression Inventory), as this group BPT intervention is not appropriate to support suicidal patients in acute crises
* Participation in any other clinical trial with a psychosocial intervention
* Receiving any other current psychotherapeutic treatment with the exception of already established therapies
* Inability to understand and speak German

Primary outcomes:
measure: Changes in bodily disturbances assessed by questionnaires
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Secondary outcomes:
measure: Changes in bodily wellbeing
timeFrame: applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions
measure: Changes in mood
timeFrame: applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions
measure: Changes in body mindfulness
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in somatic symptoms
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in somatic symptom disorder-B criteria
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in distress
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in anxiety
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in depression
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in vitality
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in mental health
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in quality of life
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
measure: Changes in suicidal tendency
timeFrame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Other outcomes:
measure: Changes in bodily disturbances assessed by semistructured interview
timeFrame: qualitative assessment at baseline and 14 weeks after baseline (=post-therapy)
measure: Change in group cohesion
timeFrame: assessed 7, 8, 9, 10, 11 and 12 weeks after baseline directly after each group session
Locations:
city: Basel
country: Switzerland
facility: Department of Psychosomatics/ Division of Medicine; University Hospital of Basel
city: Winterthur
country: Switzerland
facility: Department of Oncology and Hematology; Kantonsspital Winterthur
Study officials:
affiliation: Department of Psychosomatics/ Division of Medicine
name: Rainer M Schaefert, Prof. Dr. MD
role: STUDY_CHAIR
affiliation: Department of Psychosomatics/ Division of Medicine
name: Astrid Grossert, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grossert A, Meinlschmidt G, Schaefert R. A case series report of cancer patients undergoing group body psychotherapy. F1000Res. 2017 Sep 5;6:1646. doi: 10.12688/f1000research.12262.2. eCollection 2017.
citation: Grossert A, Meffert C, Hess V, Rochlitz C, Pless M, Hunziker S, Wossmer B, Geuter U, Meinlschmidt G, Schaefert R. 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. BMC Psychol. 2019 Dec 30;7(1):90. doi: 10.1186/s40359-019-0357-1.