Table 1.
Outcomes, assessments, and time points of assessments in the Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors trial.
| Outcome (assessment) | Time point of assessment | ||||||||
|
|
T0a | T1b | T2c | T3d | T4e | T5f | |||
| Among survivors | |||||||||
|
|
Primary outcome | ||||||||
|
|
|
Level of fatigue (Chalder FQg [32]) | ✓ | ✓ | ✓h | ✓h | ✓h | ✓h | |
|
|
Secondary outcomes | ||||||||
|
|
|
Questionnaires | |||||||
|
|
|
|
HRQoLi (EORTC QLQ-C30j [33]) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
HRQoL and health status (EQ-5D [34]) | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
|
|
Subjective vitality (SVSk [35]) | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
|
|
Satisfaction with life (SWLSl [36]) | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
|
|
Symptoms of depression (PHQ-9m [37]) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
Symptoms of anxiety (GAD-7n [38]) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
Work status (HUNTo [39]) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
Work ability (WAIp [40]) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
Perceived exercise competence (PCSq [41]) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
Diet (DIGIKOST-FFQr [42-45]) | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
|
Physical tests | |||||||
|
|
|
|
Cardiorespiratory fitness and pulmonary function (CPETs or indirect cardiorespiratory fitness testt) | ✓ | ✓ | ✓u | ✓u |
|
|
|
|
|
|
Leg strength (1 RMv in leg press) | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
|
|
Upper body strength (maximum number of push-ups performed in 1 set) | ✓ | ✓ | ✓ | ✓ |
|
|
|
|
Additional measures (patient-reported experience measures) | ||||||||
|
|
|
Perceived benefits of being part of the project (questions modified from the PasOpp surveyw [46]) |
|
|
|
|
✓ | ✓ | |
|
|
|
Perceived benefits of the 4 components of the intervention (self-made questionsw) |
|
|
|
|
✓ | ✓ | |
|
|
|
Use of experiences, strategies, and advice learned in the program (self-made questionsw) |
|
|
|
|
✓ | ✓ | |
| Among partners | |||||||||
|
|
HRQoL (RAND-36x [47]) | ✓ | ✓ | ✓ | ✓ |
|
|
||
|
|
Global health or QoL (2 items; EORTC QLQ-C30 [33]) | ✓ | ✓ | ✓ | ✓ |
|
|
||
aT0: before randomization.
bT1: 3 months after randomization.
cT2: 6 months after randomization.
dT3: 9 months after randomization.
eT4: 1-year follow-up (15 months after randomization).
fT5: 2-year follow-up (27 months after randomization).
gFQ: Fatigue Questionnaire.
hFatigue levels at T2, T3, T4, and T5 are secondary outcomes.
iHRQoL: health-related quality of life.
jEORTC QLQ-C30: European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire.
kSVS: Subjective Vitality Scale.
lSWLS: Satisfaction With Life Scale.
mPHQ-9: Patient Health Questionnaire-9.
nGAD-7: Generalized Anxiety Disorder-7.
oHUNT: Trøndelag Health Study.
pWAI: Work Ability Index.
qPCS: Perceived Competence Scale.
rDIGIKOST-FFQ: digital food frequency questionnaire.
sCPET: cardiopulmonary exercise test.
tParticipants not able to travel to Oslo University Hospital for CPET are offered an alternative indirect treadmill test, administered by an instructor at a local training facility.
uPulmonary function is not assessed at T4 and T5.
vRM: repetition maximum.
wRefer to Multimedia Appendix 2.
xRAND-36: Research and Development 36-item Short Form Health Survey.