Table 2 Overview primary, secondary outcome and independent variables
Primary outcome measures | Assessment instrument |
|---|---|
Health-related quality of life | For example, EORTC QLQ C30, FACIT, FACT, SF-36, SF-12, EQ5D. |
Secondary outcome measures and independent variables | Variable name |
Psychosocial factors | Fatigue, depression, anxiety, mood state, stress/distress, self-esteem, anger, sleep quality, social support. |
Physical activity and fitness | Functional performance (for example, 6 min walk test), muscle strength, aerobic fitness (for example, peak VO2), physical activity (objectively or by self-report). |
Body composition | Height, weight, body mass index, fat mass, lean body mass, thickness of skin folds, body fat (in percentages), arm circumference, waist circumference, hip circumference, waist-hip ratio, bone mineral density. |
Baseline characteristics | Patient identifier, center identifier, date of diagnosis, time since diagnosis, date of randomization, and timing of intervention (pre/during/post intervention or mixed timing). |
Demographic variables | Age, gender, family income, employment status, level of education, marital status, ethnicity/race, smoking, alcohol use, menopausal status, performance status (for example, Karnofsky Performance Scale). |
Clinical characteristics | Cancer diagnosis (for example, breast cancer), cancer staging and grading, TNM Classification of Malignant Tumors, oncologic history, recurrence of cancer, co-morbidities, treatment of co-morbidities, cancer-related pain, medication use, type of medication, type of treatment (for example, chemo/radio/hormone therapy), number of cycles, time since treatment, currently under treatment, complications during treatment, other treatments used (for example, immunotherapy, stem cell transplantation). |
Psychosocial intervention characteristics | Method of delivery (for example, telephone support, face-to-face), intervention type (for example, education, cognitive behavioral therapy, psychotherapeutic), intervention format (for example, group, individual, couples, web-based), total number of sessions of the intervention, number of care providers involved in the intervention, profession of care providers involved in the intervention, training given to the care providers involved in the intervention, compliance. |
Physical activity intervention characteristics | Intervention duration, exercise mode (for example, resistance, endurance), exercise intensity, exercise frequency, exercise session duration, exercise supervision, compliance. |