BPT to Improve Bodily Disturbances in Post-treatment Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2019-11-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group BPT

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.

Group Type EXPERIMENTAL

BPT

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Interventions

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BPT

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.

Intervention Type BEHAVIORAL

Smartphone-triggered bodily interventions

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.

Intervention Type BEHAVIORAL

Smartphone triggered control intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No