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Completed

NCT Number: NCT03707548

BPT to Improve Bodily Disturbances in Post-treatment Cancer Patients

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.

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Key information

Conditions

Cancer Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychosomatics/ Division of Medicine; University Hospital of Basel, Basel, Switzerland

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About this study

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:

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in bodily disturbances assessed by questionnaires

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

Secondary outcomes

  1. Changes in bodily wellbeing

    Time frame: applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions

    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.

  2. Changes in mood

    Time frame: applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions

    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.

  3. Changes in body mindfulness

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

  4. Changes in somatic symptoms

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

  5. Changes in somatic symptom disorder-B criteria

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

  6. Changes in distress

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

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

  7. Changes in anxiety

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

  8. Changes in depression

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

  9. Changes in vitality

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

  10. Changes in mental health

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

  11. Changes in quality of life

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

  12. Changes in suicidal tendency

    Time frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

    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.

Other outcomes

  1. Changes in bodily disturbances assessed by semistructured interview

    Time frame: qualitative assessment at baseline and 14 weeks after baseline (=post-therapy)

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

  2. Change in group cohesion

    Time frame: assessed 7, 8, 9, 10, 11 and 12 weeks after baseline directly after each group session

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: KPTK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2018
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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