Trial document




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  DRKS00013195

Trial Description

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Title

ACTonCancer: feasibility and effectiveness of an internet- and mobile-based acceptance and commitment therapy for cancer patients - a randomized controlled pilot study

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Trial Acronym

ACTonCancer

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URL of the Trial

http://www.act-on-cancer.de

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Brief Summary in Lay Language

A cancer diagnosis affects the course of life for patients as well as their caregivers and brings up fundamental changes. Cancer patients are likely to feel distressed by aspects of their disease which they can’t control. Barriers to mental health care are still high for cancer patients, including stigmatization or limited mobility. Internet- and mobile-based interventions are an innovative approach to overcoming these barriers and serving the psychosocial needs of this population.

This project aims at developing a guided internet- and mobile-based intervention (ACTonCancer) for adult cancer patients and evaluating its feasibility and potential effectiveness. ACTonCancer is based on acceptance and commitment therapy and will be evaluated in a parallel group randomised controlled pilot trial. Findings on feasibility, acceptability and patient outcomes will inform a future definitive randomised controlled trial.

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Brief Summary in Scientific Language

A cancer diagnosis affects the course of life for patients as well as their caregivers and brings up fundamental changes. Cancer patients are likely to feel distressed by aspects of their disease which they can’t control. Barriers to mental health care are still high for cancer patients, including stigmatization or limited mobility. Internet- and mobile-based interventions are an innovative approach to overcoming these barriers and serving the psychosocial needs of this population.

This project aims at developing a guided internet- and mobile-based intervention (ACTonCancer) for adult cancer patients and evaluating its feasibility and potential effectiveness. ACTonCancer is based on acceptance and commitment therapy and will be evaluated in a parallel group randomised controlled pilot trial. N=60 participants will be recruited and randomily assigned to either the intervention group (n=30) or a waitlist control group (n=30). Participants in the intervention group will receive standard care and get access to the guided intervention immediately. Participants in the waitlist control group will receive standard care and get access to the unguided intervention ca. 8 weeks post randomisation. The main focus of the study lies on the feasibility of the intervention, recruitment and safety procedures. Cancer-related distress, quality of life, depression, anxiety, fear of progression, pain, fatigue, psychological flexibility and spiritual well-being will be assessed before as well as 8 weeks post randomisation. Statistical data analyses will follow an intention-to-treat approach. Findings on feasibility, acceptability and patient outcomes will inform a future definitive randomised controlled trial.

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Organizational Data

  •   DRKS00013195
  •   2017/10/19
  •   [---]*
  •   yes
  •   Approved
  •   282/17, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   Participants in the intervention group will have unrestricted access to all medical and psychological offers of the health care system (standard care). Additionally, they will get access to an online training. The training is based on principles of acceptance and commitment therapy and comprises 8 modules, which can be absolved weekly. Participants will receive feedback by professional e-coaches after each module.
  •   Participants in the waitlist control group will have unrestricted access to all medical and psychological offers of the health care system (standard care). Additionally, they will get access to an online training after a waiting time of ca 8 weeks. The training is based on principles of acceptance and commitment therapy and comprises 8 modules, which can each be absolved weekly over a course of 8 weeks. Participants in this group will not receive weekly feedback.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Feasibility: there are two measurements, respectively (T1: before randomisation and T2: 8 weeks post randomisation). Process-related: Recruitment (strategies and figures), questions due to satisfaction with contents after each session
Time of measurement: Drop-out rate (T2), acceptance (questionnaire APOI (T1, T2),), adverse events (questionnaire INEP) (T1,T2)

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Secondary Outcome

All outcomes will be assessed by self-report at T1: before randomisation and T2: 8 weeks post randomisation;
cancer-related distress (distress thermometer; T1, T2), quality of life (EORTC QLQ-C30; T1, T2), Depression (PHQ-9; T1, T2), Anxiety (GAD-7; T1, T2), fear of progression (PA-F-KF; T1, T2), pain (BPI; T1, T2), fatigue (11-item FQ; T1, T2), psychological flexibility (FAH-II; T1, T2), spiritual well-being (FACIT-Sp 12; T1, T2)

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2017/10/20
  •   60
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Cancer diagnosis, age >= 18 years, access to the internet, german literacy

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Exclusion Criteria

medical objections

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Addresses

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    • Abteilung für kKinische Psychologie und Psychotherapie, Institut für Psychologie undPädagogik,Universität Ulm
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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    • Abteilung für Klinische Psychologie und Psychotherapie, Institut für Psychologie undPädagogik,Universität Ulm
    • Mr.  Prof. Dr.  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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    • Abteilung für kKinische Psychologie und Psychotherapie, Institut für Psychologie undPädagogik,Universität Ulm
    • Ms.  M.Sc.  Natalie  Bauereiß 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für kKinische Psychologie und Psychotherapie, Institut für Psychologie undPädagogik,Universität Ulm
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.