Patients and treatment
This feasibility study was performed as a single institutional prospective one-armed intervention study at Oslo University Hospital (OUH) from December 2012 to July 2013 (8 months). OUH is the only institution treating patients with newly diagnosed TC within a population of approximately 2.8 million individuals, living in the south eastern part of Norway. Most patients undergo orchiectomy at their local hospital, but are thereafter referred to OUH for staging and eventually further treatment. Risk-adapted treatment of patients with metastatic TC comprises three or four cycles of BEP or four EP [2]. Each cycle of 21 days includes 5 days at OUH receiving chemotherapy infusions (days 1–5), and 16 days at home (days 6–21). At day 15, the patients receive bleomycin intravenously at their local hospital. Post-chemotherapy residual tumor often requires surgery, most frequently retroperitoneal lymph node dissection.
Patients eligible for the present study fulfilled the following criteria: newly diagnosed metastatic TC, planned for three or four cycles with BEP/EP, without physical and psychological co-morbidities contraindicating the assessments and/or intervention as assessed by the responsible oncologist, age ≥18 years and no prior cancer (except non-melanoma skin cancer).
Intervention
Due to lack of literature regarding PA in patients with metastatic TC, we conducted upfront semi-structured interviews among 11 men who previously had received BEP/EP chemotherapy for TC. These interviews revealed reduced wellbeing, fatigue and weakness especially on the days 4–7 in each cycle. Wellbeing gradually decreased throughout the treatment period. After completion of chemotherapy, the interviewed patients reported that recovery to pre-treatment physical capacity could take several months. Most interviewed patients expressed skepticism towards performing high intensity (HI) physical exercise during chemotherapy and preferred PAs with low intensity (LI) or moderate intensity (MI).
On this background the intervention in the present feasibility study was designed as an individual low-threshold PA intervention during (Phase I) and shortly after (Phase II) chemotherapy (Fig. 1). The intervention aimed to avoid inactivity and maintenance of physical capacity. All patients got a personal coach to motivate, counsel and encourage them to follow the public health PA guidelines (≥150 min MI activity per week or ≥75 min HI activity) [13]. During the first week of treatment an individualized PA plan was developed. The patient could choose different types of PAs and the intensity should be adapted to the patient’s day-to-day wellbeing. The coach contacted the patient in person at least once during each hospitalization, and if desirable, counseled the patient during PA sessions at the training centre at the hospital. Between the hospitalizations the coach phoned the patient at least once per week, but no face-to-face counseled PA sessions were performed outside the hospital.
Phase II started after the last BEP/EP cycle and lasted for 12 weeks. The coach and the patient worked out an individual PA plan depending on the patient’s preferences. All PAs were to be performed near by the patients’ home. The coach phoned the patient every second week, encouraging him to increase the frequency, duration and intensity of PAs, at least to a level corresponding to the public health PA guidelines.
Feasibility outcomes
Patient recruitment, refusal and compliance
Eligible patients were recruited by the responsible oncologists 1–2 weeks before the first BEP/EP cycle (Fig. 1). After short oral information by the treating oncologist, the patients received written information and more detailed oral information from the study coordinator if they expressed an interest in participating. The recruitment rate was defined as the proportion of invited patients among eligible patients. Reasons for eligible patients not being invited were identified retrospectively. Refusal rate was defined as the proportion of patients among the invited that did not consent to participate. Completion rate was defined as the proportion of consenting patients who completed any measurement at the final assessment.
The patients were evaluated during the week before the first BEP/EP cycle (T0), the week after the last BEP/EP cycle (after phase I) (T1) and 12 weeks after the last BEP/EP cycle (after Phase II) (T2) (Fig. 1). The assessments included fasting blood sampling, questionnaires, a cardiopulmonary exercise test (CPET), dual-energy X-ray absorptiometry (DXA) and muscle strength tests. Assessment completion rate was defined as the proportion of completed assessments, at T0, T1 and T2 separately and summed up.
Adherence to the intervention
The patients were asked to report all types of PA including the intensity and duration in a PA log during each chemotherapy cycle. Intensity was reported according to the Borg scale [14]. PAs rated below 12 at the Borg scale were categorized as LI sessions, activities rated from 12 to 14 were categorized as MI sessions, and activities above 14 as HI sessions [14].
At T2 the patients went through a semi-structured interview, including questions related to PA preferences (Table 4) and barriers asking; “On a scale from 0 to10, how did the listed adverse effects (Table 5) hamper your level of PA during chemotherapy?” (1 = not all to 10 = to a very high degree).
Ethics
The study was approved by the Regional Committee for Medical and Health Research Ethics, South-East Region (2011/2008/REK South-East A) and registered in ClinicalTrial.gov (NCT01749774). Eligible patients willing to participate signed an informed consent form prior to testing at T0.