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An exploratory study of Dignity Therapy for people with advanced cancer

A phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for people with advanced cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29868352
Enrollment
40
Registered
2009-02-12
Start date
2009-01-05
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced cancer Cancer Malignant neoplasm of other and ill-defined sites

Interventions

Dignity Therapy: this is a brief psychotherapy to foster a sense of dignity and reduce psychological and spiritual distress in people with advanced cancer. The therapy involves a therapist conducting

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults aged greater than or equal to 18 years, either sex, with advanced cancer who have been referred to a hospital-based palliative care team. In one hospital trust only patients being cared for in the community will be included. In the other hospital only in-patients and those visiting out-patient clinics will be included. Participants will not be screened for spiritual or psychological distress, or loss of dignity, however, they will be assessed at baseline, to explore the potential moderating effects of these on the impact of the intervention.

Exclusion criteria

Exclusion criteria: 1. Patients who are considered by the palliative care team to be too ill to take part in a protocol lasting two weeks 2. Unable to provide informed consent either due to cognitive problems, or to the severity of their illness, or because they are unable to understand English

Design outcomes

Primary

MeasureTime frame
Patients' sense of dignity, assessed using the Patient Dignity Inventory at baseline, as soon as possible after the intervention has been completed and 1 month post-intervention, and the equivalent in the control group. Themes covered by this questionnaire include physical, psychosocial, existential and spiritual domains of concern or distress.

Secondary

MeasureTime frame
1. Potential effectiveness, assessed at baseline, as soon as possible after the intervention has been completed and 1 month post-intervention, and the equivalent in the control group, by the following: 1.1. Hospital Anxiety and Depression Scale 1.2. Herth Hope Index 1.3. Euroqol EQ-5D 1.4. A two-item measure of quality of life specifically designed to assess the effectiveness of the Dignity Therapy 1.5. The Distress Thermometer 2. Acceptability of Dignity Therapy (intervention group only). Patients views on the intervention assessed as soon as possible after the intervention has been completed and 1 month post-intervention using semi-structured face-to-face qualitative interviews 3. Outcomes for family, friends and recipients of "generativity" documents; potential effectiveness, assessed at three months post- bereavement for patients who die during the study period using the following: 3.1. Hospital Anxiety and Depression Scale 3.2. Complicated Grief Assessment Scale 3.3. Palliative Care Outcome Scale 4. Acceptability of Dignity Therapy (intervention group only). Views of patients' family, friends and recipients of "generativity" documents on the intervention, assessed as soon as possible after the intervention has been completed and 3 months post- bereavement (for patients who die in the study period) using semi-structured qualitative telephone interviews 5. Feasibility of delivering Dignity Therapy in this setting will be assessed by recording: 5.1. Time taken to organise and conduct the Dignity Therapy sessions, transcribe and edit narratives 5.2. Deviations from the therapy protocol and the reasons for this 5.3. The therapist?s perceptions of competence as a result of training 6. Methods for a phase III trial; to assess the feasibility our methodology, the following will be recorded: 6.1. Exclusions 6.2. Recruitment rates (patients and their family, friends and recipients of the ?generativity? documents) 6.3. Loss to follow-up 6.4. Time taken to obtain info

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026