Positive Psychology Intervention to Improve Quality of Life in Stem Cell Transplant Survivors and Their Caregivers
2 marzo 2020 aggiornato da: Fred Hutchinson Cancer Center
Feasibility of a Positive Psychology Intervention for Hematopoietic Cell Transplant Survivors to Improve Quality of Life
This trial studies a positive psychology intervention designed to improve quality of life in stem cell transplant survivors and their caregivers.
Positive psychology (PP) uses systematic exercises (e.g., gratitude letters, acts of kindness) to potentially boost levels of optimism, resilience, and life enjoyment.
PP interventions are often enjoyable, easy to understand, and can be delivered via telephone.
PP intervention may improve the quality of life of participants who have undergone a stem cell transplant or their caregivers.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Pilot a positive psychology intervention delivered to hematopoietic cell transplantation (HCT) survivors and interested caregivers over an 8 week period.
II. Determine the proportion of patients who enroll and the immediate benefit to participants, as measured by pre- and post-exercise measures of happiness and optimism.
III. Pilot outcome data collection mechanisms in preparation for a randomized clinical trial.
OUTLINE:
Participants and caregivers receive a positive psychology exercise manual, complete positive psychology exercises every week, and participate in phone sessions over 30 minutes every week for 8 weeks.
After completion of study, participants are followed up at 6 months.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
29
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Washington
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Seattle, Washington, Stati Uniti, 98109
- Fred Hutch/University of Washington Cancer Consortium
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Written informed consent
- English as primary language
- At least 1 year after HCT
Exclusion Criteria:
- Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach.
- Medical conditions precluding participation in the intervention or likely to lead to death within 6 months, as determined by the principal investigator (PI)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Participants: Positive Psychology Intervention
Participants receive a positive psychology exercise manual, complete positive psychology exercises every week, and participate in phone sessions over 30 minutes every week for 8 weeks.
|
Studi accessori
Altri nomi:
Studi accessori
Receive positive psychology manual
Altri nomi:
Complete positive psychology exercises
Participate in phone sessions
|
|
Sperimentale: Caregivers: Positive Psychology Intervention
Caregivers receive a positive psychology exercise manual, complete positive psychology exercises every week, and participate in phone sessions over 30 minutes every week for 8 weeks.
|
Studi accessori
Altri nomi:
Studi accessori
Receive positive psychology manual
Altri nomi:
Complete positive psychology exercises
Participate in phone sessions
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Study enrollment rates
Lasso di tempo: Up to 8 weeks
|
The analysis of the study will mainly be descriptive. The proportion of participants who consent to enroll in the study will be computed based on the number approached through each method. Reasons for non-participation will be summarized. A larger randomized trial will be considered feasible if the enrollment rate for patients approached in person or over the phone is > 50% (excluding the active opt-out rate) and the overall completeness of follow-up data collection is > 70%, excluding patients who have died or are hospitalized/ill at the assessment point. Since the number of caregivers who will participate is unknown, caregiver analyses will also be descriptive only. |
Up to 8 weeks
|
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Positive psychology intervention completion rates
Lasso di tempo: Up to 8 weeks
|
Up to 8 weeks
|
|
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Completeness of follow-up data collection
Lasso di tempo: Up to 8 weeks
|
Completeness is defined by the proportion of instrument scores that can be calculated per given time point.
The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales versus scales attempted to be collected or completed by patients.
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Up to 8 weeks
|
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Changes in happiness after each exercise
Lasso di tempo: Baseline up to 8 weeks
|
Change in happiness for each exercise will be analyzed by change scores.
A change of 2 points on a 0-10 scale, with 10 being happiest, is considered clinically meaningful.
|
Baseline up to 8 weeks
|
|
Changes in optimism after each exercise
Lasso di tempo: Baseline up to 8 weeks
|
Change in optimism for each exercise will be analyzed by change scores.
A change of 2 points on a 0-10 scale, with 10 being most optimistic, is considered clinically meaningful.
|
Baseline up to 8 weeks
|
|
Changes in mental health
Lasso di tempo: Baseline up to 6 months after intervention ends
|
This will be assessed with the patient-reported outcomes measurement information system, PROMIS-10 (Global-Mental).
Higher scores are better.
T scores will be used to standardize scores so that 50 represents the US general population and 10 is the standard deviation.
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Baseline up to 6 months after intervention ends
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Changes in physical health
Lasso di tempo: Baseline up to 6 months after intervention ends
|
This will be assessed with the patient-reported outcomes measurement information system, PROMIS-10 (Global-Physical).
Higher scores are better.
T scores will be used to standardize scores so that 50 represents the US general population and 10 is the standard deviation.
|
Baseline up to 6 months after intervention ends
|
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Changes in fatigue
Lasso di tempo: Baseline up to 6 months after intervention ends
|
This will be assessed with the patient-reported outcomes measurement information system, PROMIS-Fatigue.
Lower scores are better.
T scores will be used to standardize scores so that 50 represents the US general population and 10 is the standard deviation.
|
Baseline up to 6 months after intervention ends
|
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Changes in pain
Lasso di tempo: Baseline up to 6 months after intervention ends
|
This will be assessed with the patient-reported outcomes measurement information system, PROMIS-Pain interference.
Lower scores are better.
T scores will be used to standardize scores so that 50 represents the US general population and 10 is the standard deviation.
|
Baseline up to 6 months after intervention ends
|
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Changes in resilience
Lasso di tempo: Baseline up to 6 months after intervention ends
|
This will be assessed with the Connor Davidson resilience scale.
Total scores range from 0-40 with higher scores reflecting great resilience.
|
Baseline up to 6 months after intervention ends
|
|
Changes in anxiety and depression
Lasso di tempo: Baseline up to 6 months after intervention ends
|
The Hospital Anxiety and Depression Scale will be used to capture depression and anxiety.
Scores on the Anxiety and Depression subscales range from 0-21 with higher scores indicating more distress.
Subscales will be reported separately.
|
Baseline up to 6 months after intervention ends
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
18 maggio 2018
Completamento primario (Effettivo)
1 marzo 2020
Completamento dello studio (Effettivo)
1 marzo 2020
Date di iscrizione allo studio
Primo inviato
17 aprile 2018
Primo inviato che soddisfa i criteri di controllo qualità
2 maggio 2018
Primo Inserito (Effettivo)
15 maggio 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 marzo 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 marzo 2020
Ultimo verificato
1 marzo 2020
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 9969 (Altro identificatore: Fred Hutch/University of Washington Cancer Consortium)
- P30CA015704 (Sovvenzione/contratto NIH degli Stati Uniti)
- NCI-2018-00541 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .