Heim, M.E., v d Malsburg, M.L., & Niklas, A. (2007). Randomized controlled trial of a structured training program in breast cancer patients with tumor-related chronic fatigue. Onkologie, 30, 429–434.

DOI Link

Intervention Characteristics/Basic Study Process

Intervention consisted of physiotherapy, group exercises, and psycho-oncologic interventions. Patients received a brochure with instructions for nine muscle strength and nine stretching exercises for large muscle groups. Outcomes were assessed at baseline, start of intervention (T1), end of intervention (T2), and at a three-month follow-up (T3).

Sample Characteristics

  • N = 63
  • AGE: In the intervention group, 56% were aged 51–70 years
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer with cancer-related chronic fatigue
  • OTHER KEY SAMPLE CHARACTERISTICS: Control group patients were slightly younger, but otherwise both groups were well balanced. Intervention group: 56% married, 59% working, most patients had received chemotherapy (66%) and radiation therapy (81%), and 78% received hormonal therapy
  • EXCLUSION CRITERIA: Evidence of psychiatric disease or patients who were less than six weeks to preceding surgery or chemotherapy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment, inpatient rehabilitation

Study Design

  • Randomized controlled trial
    • Structured physical training intervention (N = 32)
    • Control (N = 31)

Measurement Instruments/Methods

  • Linear analogue scale (LASA)
  • Multidimensional Fatigue Inventory (MFI)
  • Functional Assessment of Cancer Treatment (FACT)

Results

Trial outcome index for fatigue in the FACT-F questionnaire showed improvement in fatigue from T1–T3. The interaction of time and group were statistically significant (p = 0.003). For MFI measures, interaction between group and time effects was significant for physical fatigue between T2–T3 (p = 0.028). The mean MFI total score was higher for both the control and intervention group in comparison to the mean MFI total score for healthy women in the age group of 40–50 years at the three-month follow-up.

Limitations

  • Small sample size

Nursing Implications

Future research should incorporate better measures for the intensity of the exercise.