BPT to Improve Bodily Disturbances in Post-treatment Cancer Patients (KPTK)

University Hospital Basel

Status: Completed

Conditions: Cancer Patients

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03707548

2018-01115 me17Schaefert2;

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

88 participants in 1 patient group

Group BPT

Experimental group

Description:

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.

Treatment:

Behavioral: Smartphone-triggered bodily interventions

Behavioral: Smartphone triggered control intervention

Behavioral: BPT