title: Quality of life after successful treatment of early-stage Hodgkin's lymphoma: 10-year follow-up of the EORTC-GELA H8 randomised controlled trial.
abstract: BACKGROUND
  Little is known about the longitudinal course of health-related quality of life (HRQoL) in patients with Hodgkin's lymphoma during their post-treatment follow-up and re-adaptation to normal life. We report on the HRQoL of patients treated in the randomised H8 trial of the European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group and the Groupe d'Etudes des Lymphomes de l'Adulte (GELA). We aimed to assess HRQoL and fatigue following treatment, to analyse relations with treatment, and to identify factors that predict persistent fatigue.
  
  
  METHODS
  Patients received HRQoL questionnaires at the end of primary therapy and during follow-up. The EORTC QLQ-C30 was used to assess HRQoL, and the Multidimensional Fatigue Inventory (MFI-20) was used to assess fatigue. Changes of mean HRQoL scores over time were analysed with mixed models. Multiple polytomic nominal logistic regression was done to identify independent baseline predictors of fatigue within MFI-20 dimensions. Analyses were done on an intention-to-treat basis. This study is registered with www.ClinicalTrials.gov, number NCT00379041.
  
  
  RESULTS
  2666 assessments from 935 patients were analysed. Mean follow-up was 90 months (range 52-118). Age affected all functioning and symptom scores except emotional functioning, with younger age associated with higher functioning and lower severity of symptoms; improvement with time showed similar patterns between age groups. Women reported lower HRQoL and higher symptom scores than did men. Overall, 3.2% (14/439 for role functioning) to 9.7% (43/442 for social functioning) and 5.8% (29/498 for reduced motivation) to 9.9% (49/498 for general fatigue) of patients reported impairments of 10 points or more (on a 0-100 scale) in QLQ-C30 and MFI-20 scores, respectively, independent of age and sex. Emotional domains were more affected than physical ones. There was no relation between HRQoL outcome and type of treatment. Fatigue (MFI-20 scores) at the end of treatment was the only predictive variable for persistent fatigue, with odds ratios varying from 2.58 (95% CI 1.00-6.67) to 41.51 (12.02-143.33; p</=0.0001). Sensitivity analyses adjusting for missing data were much the same as the main results.
  
  
  CONCLUSIONS
  HRQoL data after treatment for early-stage Hodgkin's lymphoma show that patients experience strain and limitations in all subdomains apart from cognitive functioning (QLQ-C30), and also have reduced motivation (MFI-20). Differences in HRQoL improvement with time were linked to age and sex, but not type of treatment. Fatigue status at the end of treatment seems to predict subsequent HRQoL.
  
  
  BACKGROUND
  French Ministry of Health, Programme Hospitalier de Recherche Clinique 1994, and French National League Against Cancer.
authors.affiliation: GRECAN EA-1772 and Institut Universitaire de Technologie de Caen, Université de Caen Basse-Normandie, Caen, France.
authors.forename: Natacha
authors.initials: N
authors.lastname: Heutte
authors.forename: Henning H
authors.initials: HH
authors.lastname: Flechtner
authors.forename: Nicolas
authors.initials: N
authors.lastname: Mounier
authors.forename: Wilhelmina A M
authors.initials: WA
authors.lastname: Mellink
authors.forename: Jacobus H
authors.initials: JH
authors.lastname: Meerwaldt
authors.forename: Houchingue
authors.initials: H
authors.lastname: Eghbali
authors.forename: Mars B
authors.initials: MB
authors.lastname: van't Veer
authors.forename: Evert M
authors.initials: EM
authors.lastname: Noordijk
authors.forename: Johanna C
authors.initials: JC
authors.lastname: Kluin-Nelemans
authors.forename: Elzbieta
authors.initials: E
authors.lastname: Lampka
authors.forename: José
authors.initials: J
authors.lastname: Thomas
authors.forename: Pieternella J
authors.initials: PJ
authors.lastname: Lugtenburg
authors.forename: Luisa
authors.initials: L
authors.lastname: Viterbo
authors.forename: Patrice
authors.initials: P
authors.lastname: Carde
authors.forename: Anton
authors.initials: A
authors.lastname: Hagenbeek
authors.forename: Richard Wm
authors.initials: RW
authors.lastname: van der Maazen
authors.forename: Wilma G J M
authors.initials: WG
authors.lastname: Smit
authors.forename: Pauline
authors.initials: P
authors.lastname: Brice
authors.forename: Marinus
authors.initials: M
authors.lastname: van Marwijk Kooy
authors.forename: Johanna W
authors.initials: JW
authors.lastname: Baars
authors.forename: Philip
authors.initials: P
authors.lastname: Poortmans
authors.forename: Umberto
authors.initials: U
authors.lastname: Tirelli
authors.forename: Onno C
authors.initials: OC
authors.lastname: Leeksma
authors.forename: Radka
authors.initials: R
authors.lastname: Tomsic
authors.forename: Pierre
authors.initials: P
authors.lastname: Feugier
authors.forename: Gilles
authors.initials: G
authors.lastname: Salles
authors.forename: Jean
authors.initials: J
authors.lastname: Gabarre
authors.forename: Marie José
authors.initials: MJ
authors.lastname: Kersten
authors.forename: Eric
authors.initials: E
authors.lastname: Van Den Neste
authors.forename: Geert-Jan M
authors.initials: GJ
authors.lastname: Creemers
authors.forename: Isabelle
authors.initials: I
authors.lastname: Gaillard
authors.forename: Paul
authors.initials: P
authors.lastname: Meijnders
authors.forename: Gérard
authors.initials: G
authors.lastname: Tertian
authors.forename: Oumédaly
authors.initials: O
authors.lastname: Reman
authors.forename: Hein P
authors.initials: HP
authors.lastname: Muller
authors.forename: Jacques
authors.initials: J
authors.lastname: Troncy
authors.forename: Michel
authors.initials: M
authors.lastname: Blanc
authors.forename: Wilfried
authors.initials: W
authors.lastname: Schroyens
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Voogt
authors.forename: Pierre
authors.initials: P
authors.lastname: Wijermans
authors.forename: Chantal
authors.initials: C
authors.lastname: Rieux
authors.forename: Christophe
authors.initials: C
authors.lastname: Fermé
authors.forename: Michel
authors.initials: M
authors.lastname: Henry-Amar
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006689:Hodgkin Disease / Q000188:drug therapy / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life