Promoting Dignity, Meaningfulness and Mental Well-Being

NCT ID: NCT03744442

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2023-11-15

Brief Summary

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Feasibility study to test the feasibility and acceptability of a designed personalized modular Intervention consisting of three modules, including Cancer and Living Meaningfully (CALM) Therapy, Dignity Therapy (DT), and a mindfulness-based Intervention

Detailed Description

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Patient with a life-limiting serious illness commonly experience substantial emotional and spiritual distress, death anxieties, depressive symptoms and loss of dignity and purpose in life. Fostering dignity and meaning and relieving psychological distress have been identified as a core objective for end-of-life care. However, individual's needs for dignity and psychological support at the end of life may vary. Therefore, a personalized approach is needed. On the basis of theoretical frameworks and existing dignity- fostering and meaning- based interventions, as well as an one-day workshop with international experts in the field of palliative care, a personalized modular intervention, consisting of three modules, including CALM Therapy, Dignity Therapy, and a mindfulness-based Intervention, was developed.

Conditions

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Life-limiting Serious Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dignity Therapy (DT) module

psychotherapeutic intervention asking patients about their most important achievements, roles and other important aspects of life; two structured sessions of 60 minutes conducted by a trained therapist

Group Type ACTIVE_COMPARATOR

Dignity Therapy (DT) module

Intervention Type PROCEDURE

psychotherapeutic intervention asking patients about their most important achievements, roles and other important aspects of life; two structured sessions of 60 minutes conducted by a trained therapist

CALM Therapy module

supportive-expressive psychotherapy aiming to help (1) manage the disease, symptom and treatment, and communicate with healthcare providers, to (2) adjust to changes in self-concept, personal relationships, and support needs, to (3) find a sense of meaning and purpose in life, and to (4) prepare for the future, sustain hope, and face the end of life; two structured sessions of 60 minutes conducted by a trained therapist

Group Type ACTIVE_COMPARATOR

CALM Therapy module

Intervention Type PROCEDURE

supportive-expressive psychotherapy aiming to help (1) manage the disease, symptom and treatment, and communicate with healthcare providers, to (2) adjust to changes in self-concept, personal relationships, and support needs, to (3) find a sense of meaning and purpose in life, and to (4) prepare for the future, sustain hope, and face the end of life; two structured sessions of 60 minutes conducted by a trained therapist

Mindfulness-based interventions module

Mind-body techniques reducing existential and spiritual distress and dealing with common experiences related to life-limiting diseases, including loss of control, uncertainty about the future; two structured sessions of 60 minutes conducted by a trained therapist

Group Type ACTIVE_COMPARATOR

Mindfulness-based interventions module

Intervention Type PROCEDURE

Mind-body techniques reducing existential and spiritual distress and dealing with common experiences related to life-limiting diseases, including loss of control, uncertainty about the future; two structured sessions of 60 minutes conducted by a trained therapist

Interventions

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Dignity Therapy (DT) module

psychotherapeutic intervention asking patients about their most important achievements, roles and other important aspects of life; two structured sessions of 60 minutes conducted by a trained therapist

Intervention Type PROCEDURE

CALM Therapy module

supportive-expressive psychotherapy aiming to help (1) manage the disease, symptom and treatment, and communicate with healthcare providers, to (2) adjust to changes in self-concept, personal relationships, and support needs, to (3) find a sense of meaning and purpose in life, and to (4) prepare for the future, sustain hope, and face the end of life; two structured sessions of 60 minutes conducted by a trained therapist

Intervention Type PROCEDURE

Mindfulness-based interventions module

Mind-body techniques reducing existential and spiritual distress and dealing with common experiences related to life-limiting diseases, including loss of control, uncertainty about the future; two structured sessions of 60 minutes conducted by a trained therapist

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Informed Consent as documented by signature
* Patients in palliative situation (i.e. patients suffering from an advanced, incurable, life-limiting disease with multimodal support needs)
* Estimated life expectancy ≤ 18 months
* Patients seen by the palliative consultation-liaison service at the University Hospital Basel as an in- or outpatient
* Willingness and capacity to commit at least three contacts over about 7-10 days

Exclusion Criteria

* Being delirious or otherwise substantially cognitively impaired (based on clinical consensus)
* Being too ill to complete the requirements of the study protocol
* Unable to understand and speak German
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Thomas Johnson Stiftung

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Eckstein, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Department of Psychosomatic Medicine, University Hospital Basel

Locations

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Department of Psychosomatics, University Hospital of Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-01998, va18Eckstein

Identifier Type: -

Identifier Source: org_study_id

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