Six group BPT sessions (using a waiting-period comparator and pre-/post design)

A nested randomized controlled trial (RCT) is included to evaluate the short-term efficacy of smartphone-triggered bodily interventions compared with the smartphone triggered control intervention of audio-typed fairy tales.

BPT will consist of 6 weekly group sessions, based on a scientific approach, integrating body-oriented techniques to improve patients' awareness, perception, acceptance, and expression regarding their body.

Smartphone-triggered bodily interventions will consist of brief BPT exercises insuring the transfer from the group BPT sessions into patients' daily lives. Smartphone bodily interventions will be triggered by short audio-clips.

Smartphone-triggered bodily interventions

The smartphone triggered control intervention will be selected fairy tales presented by audio-clips.

Smartphone triggered control intervention

Rainer M Schaefert, Prof. Dr. MD

Astrid Grossert, MSc

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.

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.

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.

BPT to Improve Bodily Disturbances in Post-treatment Cancer Patients

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

self-perception of change in appearance and displeasure with change or perceived change in appearance; assessed via semistructured interview

Group cohesion is assessed by the Group Climate Questionnaire - Short Form (GCQ-S). The questionnaire consists of a total score and 3 subscales (all ranges from 0 to 6): Scale 1: Engaged: This describes the positive working group atmosphere. Scale 2: Conflict: This reflects anger and tension in the group. Scale 3: Avoiding: This describes behaviors indicating avoidance of personal responsibility of group work by the members. Higher values represent a higher degree in engagement, conflict, or avoiding. Scales scores are determined by calculating the mean of the relevant items.

self-perception of change in appearance and displeasure with change or perceived change in appearance; assessed via Body Image Scale (BIS). BIS total score is calculated by adding the score obtained on each item, yielding a possible range from 0-30. Higher scores indicate a higher degree of body image dissatisfaction.

bodily wellbeing is assessed by Multidimensional Mood Questionnaire (MDMQ). 3 scales are calculated: "good-bad", and "awake-tired", "calm-nervous". Scores are calculated by adding the score obtained on each item, yielding a possible range from 4-20 in each scale. Higher values represent a better outcome.

mood is assessed by Multidimensional Mood Questionnaire (MDMQ). 3 scales are calculated: "good-bad", and "awake-tired", "calm-nervous". Scores are calculated by adding the score obtained on each item, yielding a possible range from 4-20 in each scale. Higher values represent a better outcome.

assessed by Body Mindfulness Questionnaire (BMQ). 2 scales are calculated: "Experiencing Body Awareness", and "Appreciating Body Awareness". Scores are calculated by adding the score obtained on each item, yielding a possible range from 7-42 in each scale. Higher values represent a better outcome.

somatic symptoms are assessed by the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items). All scales and single-item measures range in scores from 0 to 100. A high score represents a high level of symptomatology. The following somatic symptom scales are calculated: fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea. The principle for scoring these scales is the same in all cases: 1.The average of the items that contribute to the scale is estimated; this is the raw score. 2. A linear transformation is used to standardise the raw score, so that scores range from 0 to 100.

somatic symptom disorder-B criteria are assessed by Somatic Symptom Disorder-B Criteria Scale (SSD-12). 1 total score and 3 subscores are calculated: "cognitive aspects", "affective aspects", and "behavioral aspects". Scores are calculated by adding the score obtained on each item. Range for subscales: 0-16; range for total score: 0-48; higher scores are representing greater severity.

distress is assessed by National Comprehensive Cancer Network Distress Thermometer (DT). A visual analogue scale ranging from 0=no distress to 10=extreme distress.

anxiety is assessed by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The anxiety-score is calculated by adding the score obtained on each item, range 0-21, with higher scores representing greater severity.

Depression is assessed by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The depression-score is calculated by adding the score obtained on each item, range 0-21, with higher scores representing greater severity.

vitality is assessed by the 36-Item Short Form Health Survey (SF-36) - scale vitality. Items in the scale are averaged together to create the vitality score. Range from 0 to 100, a higher score defining a more favorable health state.

mental health is assessed by the 36-Item Short Form Health Survey (SF-36) - scale mental health. Items in the scale are averaged together to create the mental health score. Range from 0 to 100, a higher score defining a more favorable health state.

quality of life is assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30). The following scales are computed: global health status/quality of life, physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. All scales range in scores from 0 to 100. A high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high quality of life. The principle for scoring these scales is the same in all cases: 1.The average of the items that contribute to the scale is estimated; this is the raw score. 2. A linear transformation is used to standardise the raw score, so that scores range from 0 to 100.

suicidal tendency is assessed by the Beck Depression Inventory (BDI-II), Item I: Suicidal tendency. Range from 0 to 3, a higher value representing a higher suicidal tendency.

Spots Global Cancer Trial Database for smartphone triggered control intervention