Person-centred Support for Women After Treatment for Gynaecological Cancer

NCT01784406 | Completed

• 1 other identifier: H-4-2012-FSP(94)
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Women treated for gynaecological cancer perceive many difficulties in life on the personal, social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the hospital where the main purpose is to improve survival. However, the women are very nervous before follow-up visits and although they feel safe about them, they express that their needs of psychosocial care and self-management support are not fulfilled. The proposed study will test a person-centred intervention tailored the women's needs in a randomised controlled trial. The intervention will be based on the method Guided Self Determination (GSD), which has proved able to realize empowerment in practice in relationships between patients and healthcare professionals. GSD involves systematic use of condition-adjusted worksheets ('reflection sheets'), and advanced professional communication. Using reflection sheets filled out by each woman as the starting point for communication, problem solving will be tailored her personal needs. We expect that the intervention has the potential to support the women in better managing specific complications and difficulties related to concerns about recovery, body perception, fertility and establishment of intimate relations with their partner, all aspects important for the women's quality of life in the follow-up period after cancer diagnosis and treatment. The study will be the first to test GSD in cancer patients.

Conditions

Malignant Female Reproductive System Neoplasm; Follow-up; Supportive Care; Psychosocial Circumstances; Survivorship

Keywords

Self-management intervention; Psychosocial care; Autonomy-supportive; Gynaecological cancer survivors; Guided self-Determination

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)

  +/- one week for practical reasons

  9 months after randomisation

Secondary Outcomes (8)

• Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS)

  3 months after randomisation

• Changes in Quality of life in the two groups

  9 months

• Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2)

  3 and 9 months after randomisation

• Self-esteem measured by Rosenbergs Self Esteem Scale

  3 and 9 months after randomisation

• Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)

  3 and 9 months from randomisation

Study Arms (2)

Autonomy-supportive counselling

EXPERIMENTAL

2-4 autonomy-supportive conversations with an experienced nurse, educated both theoretically and practically in the method Guided Self-Determination that includes specific "reflection sheets" and use of advanced communication; in addition to standard care.

Behavioral: Autonomy supportive counselling

Control

NO INTERVENTION

Standard of care.

Interventions

Autonomy supportive counselling BEHAVIORAL

Autonomy-supportive counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women only surgically treated for cervix, ovarian (including borderline tumors), endometrial or vulva cancer, who attend follow up at the Gynaecological Department at The University Hospital Rigshospitalet in Copenhagen.
• The women should read, write and understand the danish language.

You may not qualify if:

• Known recurrence.
• Participation in the preliminary pilotstudy.
• Health related problems both physical or psychological, that prevent participation. For example cognitive impairment, or patients with psychiatric diseases that is estimated to require nurses with competences within the psychiatric speciality.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Related Links

• Statistical analysis plan
• Copenhagen University Hospital, Rigshospitalet has changed to a new web system therefore a new url adress/Statistical analysis plan

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d student

Study Record Dates

• First Submitted: February 3, 2013
• First Posted: February 5, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

DK (1)