title: The psychosocial needs of gynaecological cancer survivors: A framework for the development of a complex intervention.
abstract: OBJECTIVE
  To develop and pilot test an intervention targeting the women's psychosocial needs during the follow-up period after surgical treatment for gynaecological cancer.
  
  
  METHODS
  The project consisted of four phases. Phase 1 involved development of an intervention on the basis of meetings with key healthcare professionals, a literature review and six semi-structured interviews with women who attended the existing follow-up program. The Guided Self-Determination (GSD) method developed in diabetes care was identified as an appropriate framework for the intervention. GSD consists of reflection sheets for patients and advanced professional communication skills. The GSD method was adapted to women in a follow-up program after gynaecologic cancer treatment (GSD-GYN-C). Phase 2 involved primary pilot testing of the intervention and the findings were used to modify the intervention in phase 3. This modification involved the development of additional reflection sheets and a fidelity assessment tool. A systematic training program was arranged for the GSD-GYN-C-nurses. Phase 4 involved secondary pilot testing where nurses and women confirmed the applicability of GSD-GYN-C and final adjustments were made. Selected measurements were tested for sensitivity during pilot testing. Data from phase 2 and 4 were also used to select the primary outcome and calculate power for a future randomized clinical trial (RCT).
  
  
  RESULTS
  Pilot testing supported our hypothesis that GSD-GYN-C may be transferable and useful to survivors of gynaecological cancer.
  
  
  CONCLUSIONS
  GSD-GYN-C was developed and validated and is now ready for evaluation in an RCT.
authors.affiliation: Juliane Marie Centre, Research Unit Women's and Children's Health Dept. 7821, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. Electronic address: mette.linnet.olesen@regionh.dk.
authors.forename: Mette Linnet
authors.initials: ML
authors.lastname: Olesen
authors.affiliation: Juliane Marie Centre, Research Unit Women's and Children's Health Dept. 7821, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Helena
authors.initials: H
authors.lastname: Hansson
authors.affiliation: Juliane Marie Centre, Dept. 4074, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Bent
authors.initials: B
authors.lastname: Ottesen
authors.affiliation: Juliane Marie Centre, Gynaecology Dept. 4232, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Ingrid Regitze
authors.initials: IR
authors.lastname: Thranov
authors.affiliation: Finsencenter, Oncology Dept. 5074, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Lise Bjerrum
authors.initials: LB
authors.lastname: Thisted
authors.affiliation: Juliane Marie Centre, Research Unit Women's and Children's Health Dept. 7821, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Zoffmann
mesh_terms: D003376:Counseling; D005260:Female; D005833:Genital Neoplasms, Female / Q000523:psychology* / Q000628:therapy; D006301:Health Services Needs and Demand; D006801:Humans; D007407:Interviews as Topic; D010865:Pilot Projects; D011209:Power, Psychological; D016730:Program Development; D012107:Research Design; D012648:Self Care; D012944:Social Support; D011795:Surveys and Questionnaires; D017741:Survivors / Q000523:psychology*
keywords: Cancer survivorship; Complex interventions; Empowerment; Fidelity; Follow-up; Guided self-determination; Gynaecological cancer; Psychosocial support; Rehabilitation; Self-management