BPT to Improve Bodily Disturbances in Post-treatment Cancer Patients

NCT03707548 | Completed

• 1 other identifier: 2018-01115; me17Schaefert2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (12)

• Changes in bodily wellbeing

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

• Changes in mood

  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

  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

  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

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

Other Outcomes (2)

• Changes in bodily disturbances assessed by semistructured interview

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

• Change in group cohesion

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

Study Arms (1)

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.

Behavioral: BPT; Behavioral: Smartphone-triggered bodily interventions; Behavioral: Smartphone triggered control intervention

Interventions

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.

Group BPT

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.

Group BPT

Smartphone triggered control intervention BEHAVIORAL

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

Group BPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• existing bodily disturbances
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

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

Basel, 4031, Switzerland

Location

Department of Oncology and Hematology; Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 29067164 BACKGROUND

• 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.

  PMID: 37639296 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.

  PMID: 37089722 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.

  PMID: 31888741 DERIVED

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 16, 2018
• Study Start: September 3, 2018
• Primary Completion: September 30, 2019
• Study Completion: November 5, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

CH (2)