Trial document




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  DRKS00013206

Trial Description

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Title

Interaction at the end of life in dyads of parents and adult children

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Trial Acronym

Dy@EoL

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URL of the Trial

https://www.mhh.de/allgmed/dyeol

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Brief Summary in Lay Language

With an aging society, the number of parents who are confronted with the death of their adult child is rising [1]. In Germany, approximately 16.000 adults die every year before reaching the age of 45 [1]. A considerable percentage of them is being survived by at least one parent and receives palliative care prior to their death. At the same time, adult children continue to be confronted with their parents’ terminal illnesses and end-of-life situations.

According to the World Health Organization definition of palliative care, palliative care seeks to improve the quality of life of both patients and their families facing life-threatening illness [2]. Thus, the present research project focuses on the two dyads of adult children suffering from a life-threatening disease and their parents and terminally ill parents and their adult children.

This explorative study (project duration: 01/10/2017 – 30/09/2020) aims at describing specifics of the interaction between dyads of both patient and family member groups in order to develop recommendations for specific psychosocial support interventions. Points of view of both groups are key to understanding support needs.

Research questions are: What are the specifics of the interaction between a) adult children suffering from a life-threatening disease at their end of life and their parents and differences in comparison to the specifics of the interaction of b) terminally ill parents and their children? What are the needs of patients and their family members?

The proposed investigation uses an exploratory mixed-methods framework.

1) Interviews and questionnaires will be used with patients and relatives to record expectations, motivations, wishes, and difficulties with regard to the dyad’s communication, perceived burden, support, information about illness and prognosis, as well as caregiving role at the end of life.

2) A theoretical concept will be developed on the basis of the analysis of qualitative interviews and quantitative questionnaires to answer the research question.

3) Interview and questionnaire results will then be presented, discussed, and augmented in an expert workshop. The workshop also serves to develop recommendations for psychosocial interventions.

4) Finally, results from the expert workshop will be put into writing and recommendations will be drafted and consented (online) by the scientific advisory group.

To ensure high-quality support and care provision for terminally ill and dying patients and their relatives, their specific needs must be taken into account and psychosocial interventions must be made available. Examining with scientific methods the specifics of the interaction between adult children suffering from a life-threatening disease and their parents in comparison to the interaction of terminally ill parents and their children may provide better understanding of the distinct psychosocial needs of both dyads and may decrease the likelihood of developing negative health outcomes while increasing quality of life of patients and their relatives.

References:
1. Bundesamt für Statistik, Bevölkerung und Erwerbstätigkeit. Natürliche Bevölkerungsbewegung 2014. (Subject matter series 1 Series 1.1) 2017, Statistisches Bundesamt: Wiesbaden.
2. World Health Organization, WHO Definition of Palliative Care. Available at http://www.who.int/cancer/palliative/definition/en/ [accessed 23/10/2017].

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Brief Summary in Scientific Language

Both palliative care patients and their family members face challenges in end-of-life care [1-4]. Relationship status between caregiver and patient may affect interaction at the end of life. Interaction between ill child and their parents may differ from interaction between an ill parent and their children in terms of communication, information about illness, expressed and perceived burden and support as well as caregiving role. Being the parent of a terminally ill adult child may pose different challenges and elicit different support needs than being the healthy adult child who is taking care of a parent who is – rather expectedly – survived by the child.

So far, no study has focused on and compared the specific interaction of these two dyads. This study will investigate and describe specifics of the interaction between the dyads parent – terminally ill child vs. child – terminally ill parent using a mixed-methods framework. Interaction among terminally ill adult children and their parents and terminally ill parents and their children will be explored via in-depth face-to-face interviews and self-report questionnaires. This will result in an overview of the similarities and differences in specifics of the interaction between both groups. Recommendations for psychosocial support needs of both groups will be given.

The main research question is: What are the specifics of the interaction between a) adult children suffering from a life-threatening disease at their end of life and their parents and differences in comparison to the specifics of the interaction of b) terminally ill parents and their children?

The primary goal is to describe specifics of the interaction between dyads of both study groups in order to gain insights into similarities and differences between both groups.

The main expected results are i) a description of specifics of the interaction between dyads of both study groups, ii) the development of hypotheses and a theoretical framework on the specifics, similarities, and differences for both groups, and iii) clinical conclusions on specific psychosocial care and support needs of both groups.

References:
1. Kehl KA, Kirchhoff KT, Kramer BJ, Hovland-Scafe C 2009. Challenges Facing Families at the End of Life in Three Settings. J Soc Work End Life Palliat Care 5(3 & AMP):144-168.
2. Andershed B 2005. Relatives in end-of-life care – part 1: a systematic review of the literature of the five last years, January 1999-February 2004. J Clin Nurs 15(9):1158-1169.
3. Oechsle K, Goerth K, Bokemeyer C, Mehnert A 2013. Anxiety and depression in caregivers of terminally ill cancer patients: impact on their perspective of the patients' symptom burden. J Palliat Med 16(9):1095-1101.
4. Oechsle K, Goerth K, Bokemeyer C, Mehnert A 2013. Symptom burden in palliative care patients: perspectives of patients, their family caregivers, and their attending physicians. Support Care Cancer 21(7):1955-1962.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00013206
  •   2017/10/27
  •   [---]*
  •   yes
  •   Approved
  •   7610, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   01GY1711  (BMBF Förderkennzeichen)
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Health Condition or Problem studied

  •   Terminally ill adult children who receive palliative and/or hospice care and their parents as well as terminally ill parents who receive palliative and/or hospice care and their adult children
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Interventions/Observational Groups

  •   Patients and relatives are interviewed once via face-to-face qualitative semi-strcutured in-depth interviews and assessed via quantitatvie self-report questionnaires.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Qualitative and quantitative overview of characteristics of interaction of both dyads

The qualitative overview is obtained by one-time semi-structured in-depth interviews and the quantitative overview is obtained from questionnaires. The following questionnaires are used: 1) demographic questionnaire, 2) Relationship-specific Attachment Scales for Adults, 3) Berlin Social Support Scales, and 4) Graphic Closeness Scale.

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Secondary Outcome

na

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • Medical Center 
  • other 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/02/22
  •   48
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion criteria comprise for dyad A) terminally ill patients 18 years of age or older who are seeking palliative or hospice care and who are in contact with at least one living parent and for dyad B) terminally ill parents who are seeking palliative or hospice care and who are in contact with at least one child age 18 years or older.

Dyads of parents and children related through adoption or fosterage will be included.

Having received comprehensive oral and written information about the nature, the content and aim of the study and about study participation, both patient and family member/s provide written informed consent in order to be eligible to participate as a dyad in this project.

If the terminally ill patient is not available to participate in the study, but agrees that the project team contacts an eligible relative for study participation, this relative will be offered study participation. If one of the dyad partners refuses to participate in the study or withdraws consent before, during or after the study, the already collected data of the respective dyad partner may be used in the study or the planned data collection can take place respectively.

Individuals of both sexes and all ethnic backgrounds independent of their main diagnosis may participate in the study.

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Exclusion Criteria

Exclusion criteria include (1) significant emotional distress during interview, (2) cognitive impairment such as dementia, (3) non-proficiency in German, (4) patient and/or family member does not consent to participate in the study.

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Addresses

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    • Medizinische Hochschule Hannover, Institut für Allgemeinmedizin
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Institut für Allgemeinmedizin
    • Ms.  Dr. phil.  Franziska A.  Herbst 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Institut für Allgemeinmedizin
    • Ms.  Dr. phil.  Franziska A.  Herbst 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/11/30
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* This entry means the parameter is not applicable or has not been set.