An interventional study of German PRO-SELF(c) Plus Pain Control Program (PCP) and Standard Care in Neoplasm Metastasis, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-09.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Supportive care
The purpose of this pilot study is to refine and test an advanced and adapted German version of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention directed at cancer pain patients and their families to enhance their pain self management abilities, and to calculate effect sizes for the planning of a sufficiently powered randomized controlled trial (RCT).
Background: Cancer patients experience multiple symptoms throughout the different stages of their illness, with pain as one of the most frequent. Even though effective treatment options exist, more than 40% of all cancer pain patients do not receive adequate pain management. For pain control, in addition to state of the art treatment by professionals, patients and their family caregivers (FCs) have to use self care strategies on a daily basis, a complex process that profits from targeted support by health care providers (HCPs). In phase 1 of this study, the intervention and the study instruments have been translated, adapted and advanced.
Aims: The purpose of this pilot study is to refine and test an advanced and adapted German version of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention directed at cancer pain patients and their families to enhance their pain self management abilities, and to calculate effect sizes for the planning of a sufficiently powered randomized controlled trial (RCT).
Methods: The advanced and adapted German version of the PRO-SELF© Plus PCP will be tested in a pilot RCT in cancer patients with pain from bone metastasis, compared with standard care, with effect sizes being calculated for the planning of a sufficiently powered RCT. A qualitative sub study will explore patients' and FCs' experiences with pain management, with the educational intervention, and their view of burden and benefit from study participation.
Intervention: The PRO-SELF© Plus PCP is based on three key strategies: (a) provision of information, (b) skill building, and (c) nurse coaching. The 10-week educational program comprises a structured part (teaching of pain management skills including the use of a weekly pillbox, the use of a pain management diary and written instructions on how to communicate with the physician about unrelieved pain) and a tailored part. The patient's answers on questions about his knowledge of pain management serve as basis for tailoring the teaching (academic detailing).
Data analysis: Main outcome variables will be average and worst pain as reported daily by the patient. In order to determine effect sizes for main effect of group, main effect of time and the group by time interaction a repeated measure longitudinal design will be used employing a linear mixed model approach. For the qualitative part, interviews will be analyzed using content analysis.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 39 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Group receives 10 weeks German PRO-SELF(c) Plus PCP intervention program
Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP)
control group receives attention control and standard care
Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP) · Other: Standard Care
Educational intervention directed at patients and their family caregivers to reduce cancer pain and related symptoms
Patients in the standard care group will receive routine care provided by their treating physicians without any further care concerning the PRO-SELF© PCP. Patients in the standard care group will be seen by a research nurse in their homes at weeks 1, 2, 4, 6, 8 and 10 and telephone interviews will be conducted at weeks 3, 5, 7 and 9 but the focus of the visits and phone calls will be data collection only.
average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain)
Time frame: measured daily for 10 weeks and in week 14 and 22
patients' knowledge of cancer pain management
Time frame: baseline, week 6, 10, 14 and 22
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland