Graded activity is an important component in cognitive behavioral therapy to reduce severe fatigue: results of a pragmatic crossover trial in cancer survivors

Figures & data

Figure 1. Design of the two-period crossover study. T0: baseline assessment; T1: assessment before crossover; T2: assessment at end of therapy.

Figure 2. Flow-chart of patient participation. Group AB = graded activity followed by the other elements/condition BA = other elements followed by graded activity. T0: baseline assessment; T1: assessment before crossover; T2: assessment at end of therapy.

Table 1. Baseline characteristics of completers of T1.

	Group AB (N = 41)	Group BA (N = 48)
Age, mean (SD) years	45.4 (12.0)	45.1 (12.0)
Sex, n (%)
Female	22 (54%)	29 (60%)
Male	19 (46%)	19 (40%)
Married/ living together, n (%)
Yes	34 (83%)	38 (79%)
No	7 (17%)	10 (21%)
Education level, n (%)^a
Low	4 (10%)	5 (10%)
Middle	15 (37%)	16 (33%)
High	22 (54%)	27 (56%)
Tumor type, n (%)
Breast cancer	12 (29%)	15 (31%)
Testicular cancer	5 (12%)	7 (15%)
Hematologic cancer	12 (29%)	8 (17%)
Gynecological cancer	3 (7%)	3 (7%)
Other	9 (22%)	15 (31%)
Time since cancer treatment mean (SD) months	40.9 (23.9)	57.6 (53.2)
Missing	9 (22%)	10 (21%)
Type of cancer treatment, n (%)^b
Surgery	34 (83%)	41 (85%)
Chemotherapy	32 (78%)	34 (71%)
Radiotherapy	24 (59%)	27 (56%)
Hormone therapy (Tamoxifen)	3 (7%)^c	6 (13%)^c
Stem cell transplantation	2 (5%)^c	2 (4%)^c
Radioactive iodine	1 (2%)^c	2 (4%)^c
Targeted therapy (Herceptin)	3 (7%)	6 (13%)

CIS-Fatigue: Checklist Individual Strength, subscale Fatigue Severity; SIP-8: Sickness Impact Profile-8; T1: assessment before crossover.

Baseline characteristics did not differ significantly between the two conditions (p > .05). Group AB = graded activity followed by the other elements; group BA = Other elements followed by graded activity.

^a Education level was categorized according to the Dutch national public health compass.

^b Percentages do not add up to 100% because more options are possible.

^c Fisher’s exact test was used because of violation of the assumption of minimum expected cell frequency.

Table 2. Scores on all outcomes in the graded activity group (A) and the group that received the other CBT elements (B) at T0 and T1.

	Group A			Group B
	n	T0	T1	n	T0	T1
Fatigue severity	41	45.5 (5.3)	31.1 (10.7)	48	46.7 (5.8)	36.0 (10.2)
Objective physical activity^a	38	66.4 (17.0)	82.3 (18.9)	47	64.2 (17.0)	68.9 (17.2)
Perceived activity^b	41	16.0 (3.9)	10.4 (4.6)	46	14.9 (4.5)	12.8 (4.5)
Self-efficacy^c	41	17.8 (3.0)	21.3 (3.0)	47	18.2 (2.8)	21.8 (3.2)

CBT: cognitive behavioral therapy; PA: physical activity; T0: baseline assessment; T1: assessment before crossover.

^a Higher scores indicate a higher number of accelerations a day, reflecting a higher mean level of daily physical activity.

^b Lower scores indicate higher levels of perceived activities.

^c Higher scores indicate a higher sense of control regarding fatigue.

Table 3. The total (c-path) and direct effect of graded activity on fatigue severity (c’-path), the effect of graded activity on the potential mediators (a-path), the effect of the potential mediator on fatigue severity (b-path) and the mediation effect (a × b).

c-path	Mediator variable	c’-path	a-path	b-path	a × b
β (95% CI)		β (95% CI)	β (95% CI)	β (95% CI)	β (95% CI)
−4.99 (−9.40; −0.58)*
	Objective PA	−4.12 (−8.90; 0.56)	11.62 (4.98; 18.26)*	−0.04 (−0.18; 0.11)	−0.42 (2.41; 1.91)
	Subjective PA	−0.52 (−4.06; 3.03)	−2.72 (−4.52; −0.92)*	1.53 (1.13; 1.94)*	−4.17 (−7.37; −1.37)*
	Self-efficacy	−5.29 (−9.19; −1.40)*	−0.37 (−1.56; 0.82)	−1.82 (−2.52; −1.12)*	−0.67 (−1.59; 2.83)

PA: physical activity; 95% CI: 95% confidence interval.

^* p < .05.