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We conducted a randomized, controlled trial of dignity therapy for terminally ill patients with the aim of reducing dignity-related distress and demoralization and improving spiritual well-being.
Sample size assessment: A recent meta-analysis showed that dignity interventions reach on average effect sizes of -1.01 on emotional distress (Ho and Shin, 2014). Power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 26 participants to detect effect sizes of 1.01 and higher.
Plan for missing data: Occasional missing values were imputed by calculating, for each participant, the average score for each subscale and then replaced.
Statistical analysis plan: We conducted a 2 (group) X 3 (time [pre-treatment vs. post-treatment vs follow-up]) repeated measures multivariate analysis of variance (MANOVA) for a set of variables
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dignity Therapy Group | Experimental | Dignity Therapy is a short-term psychotherapy aimed at improving patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress. Therapy sessions, lasting between 20 and 60 minutes, were offered at the patients' bedside and audiotaped, and were conducted by a trained psyco-oncologist. After each therapy session, the audiotaped interview data were transcribed verbatim by a different psycho-oncologist and edited and reshaped into a written narrative by an expert in DT over the course of the next two to three days. Once the editing process was completed, another session was held to allow the therapist to read the "generativity document" to the patient and to make any editorial changes the patient deemed necessary. The final version of the generativity document was given to the patient to bequeath it to individuals of their choosing |
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| Control Group (Standard Palliative Care) | No Intervention | Standard Palliative Care was performed by a multidisciplinary care team composed of a palliative doctor, a psycho-oncologist, a nurse, a physiotherapist, a healthcare assistant, a social assistant, a volunteer and a spiritual assistant, tailoring care to the needs of patients and their families. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dignity Therapy | Behavioral | Intervention aimed at enhancing patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Pre-test to Post-test and Follow-up in Spiritual Well-Being, which will be reported in the outcome measure results data table as means and standard deviations. | Spiritual well-being will be measured with the FACIT-Sp (minimum value=0; maximum value=48, with higher scores indicating a better outcome), a questionnaire assessing faith, peace and meaning | Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Pre-test to Post-test and Follow-up in Demoralization, which will be reported in the outcome measure results data table as means and standard deviations. | Demoralization will be measured with the Demoralization Scale (minimum value=0, maximum value=32, with higher scores indicating a worse outcome), which assesses 1) Loss of Meaning and Purpose and 2) Distress and Coping Ability | Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Lombardo, MD | Contact | +396588991 | luigi.lombardo@virgilio.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Iani, PhD | European University of Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Sanità e Ricerca | Recruiting | Roma | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32670169 | Derived | Iani L, De Vincenzo F, Maruelli A, Chochinov HM, Ragghianti M, Durante S, Lombardo L. Dignity Therapy Helps Terminally Ill Patients Maintain a Sense of Peace: Early Results of a Randomized Controlled Trial. Front Psychol. 2020 Jun 25;11:1468. doi: 10.3389/fpsyg.2020.01468. eCollection 2020. |
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All collected IPD
Data will become available after the study will be published
Through the depository Figshare
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D003643 | Death |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000096225 | Dignity Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Change from Pre-test to Post-test and Follow-up in Dignity-related Distress, which will be reported in the outcome measure results data table as means and standard deviations. | Dignity-related Distress will be measured with the Patient Dignity Inventory (minimum value=25, maximum value=125, with higher scores indicating a worse outcome) | Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment) |