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Completed

NCT Number: NCT01784406

Person-centred Support for Women After Treatment for Gynaecological Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Autonomy supportive counselling

Behavioral

Primary outcomes

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

    Time frame: 9 months after randomisation

    +/- one week for practical reasons

Secondary outcomes

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

    Time frame: 3 months after randomisation

    +/- one week for practical reasons

  2. Changes in Quality of life in the two groups

    Time frame: 9 months

    Quality of life at 9 months minus the quality of life at the time of randomisation.

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

    Time frame: 3 and 9 months after randomisation

    +/- one week for practical reasons

  4. Self-esteem measured by Rosenbergs Self Esteem Scale

    Time frame: 3 and 9 months after randomisation

    +/- one week for practical reasons

  5. Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 and 9 months from randomisation

    Also used as screening instrument baseline.

    +/- one week for practical reasons

  6. Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ)

    Time frame: 3 and 9 months from randomisation

    +/- one week for practical reasons

  7. Distress measured by Distress Thermometer(DT).

    Time frame: 3 and 9 months from randomisation

    Also used as screening instrument baseline.

    +/- one week for practical reasons.

  8. Symptom monitoring and recognition

    Time frame: 3 and 9 months after randomisation (+/- one week for practical reasons)

    Womens ability to know what symptoms to monitor and react to in case of recurrence

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial

Acronym: PESU

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2013
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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