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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group BPT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bodily disturbances assessed by questionnaires | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bodily wellbeing | 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. | applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bodily disturbances assessed by semistructured interview | self-perception of change in appearance and displeasure with change or perceived change in appearance; assessed via semistructured interview | qualitative assessment at baseline and 14 weeks after baseline (=post-therapy) |
| Change in group cohesion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer M Schaefert, Prof. Dr. MD | Department of Psychosomatics/ Division of Medicine | Study Chair |
| Astrid Grossert, MSc | Department of Psychosomatics/ Division of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychosomatics/ Division of Medicine; University Hospital of Basel | Basel | 4031 | Switzerland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29067164 | Background | 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. | |
| 37639296 | Derived | Meinlschmidt G, Grossert A, Meffert C, Roemmel N, Hess V, Rochlitz C, Pless M, Hunziker S, Wossmer B, Geuter U, Schaefert R. Smartphone-Based Psychotherapeutic Interventions in Blended Care of Cancer Survivors: Nested Randomized Clinical Trial. JMIR Cancer. 2023 Aug 28;9:e38515. doi: 10.2196/38515. |
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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:
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| Smartphone-triggered bodily interventions | Behavioral | 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 control intervention | Behavioral | The smartphone triggered control intervention will be selected fairy tales presented by audio-clips. |
|
| Changes in mood | 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. | applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions |
| Changes in body mindfulness | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in somatic symptoms | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in somatic symptom disorder-B criteria | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in distress | distress is assessed by National Comprehensive Cancer Network Distress Thermometer (DT). A visual analogue scale ranging from 0=no distress to 10=extreme distress. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in anxiety | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in depression | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in vitality | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in mental health | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in quality of life | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
| Changes in suicidal tendency | 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. | Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy) |
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. |
| assessed 7, 8, 9, 10, 11 and 12 weeks after baseline directly after each group session |
| Department of Oncology and Hematology; Kantonsspital Winterthur |
| Winterthur |
| 8401 |
| Switzerland |
| 37089722 | Derived | Grossert A, Meffert C, Hess V, Rochlitz C, Pless M, Hunziker S, Wossmer B, Geuter U, Meinlschmidt G, Schaefert R. Group-based body psychotherapy improves appreciation of body awareness in post-treatment cancer patients: A non-randomized clinical trial. Front Psychol. 2023 Apr 6;14:956493. doi: 10.3389/fpsyg.2023.956493. eCollection 2023. |
| 31888741 | Derived | 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. |