Positive Psychology Intervention to Improve Quality of Life in Stem Cell Transplant Survivors and Their Caregivers
2. März 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
29
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Washington
-
Seattle, Washington, Vereinigte Staaten, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Nebenstudien
Andere Namen:
Nebenstudien
Receive positive psychology manual
Andere Namen:
Complete positive psychology exercises
Participate in phone sessions
|
|
Experimental: 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.
|
Nebenstudien
Andere Namen:
Nebenstudien
Receive positive psychology manual
Andere Namen:
Complete positive psychology exercises
Participate in phone sessions
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Study enrollment rates
Zeitfenster: 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
|
|
Positive psychology intervention completion rates
Zeitfenster: Up to 8 weeks
|
Up to 8 weeks
|
|
|
Completeness of follow-up data collection
Zeitfenster: 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.
|
Up to 8 weeks
|
|
Changes in happiness after each exercise
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Baseline up to 6 months after intervention ends
|
|
Changes in physical health
Zeitfenster: 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
|
|
Changes in fatigue
Zeitfenster: 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
|
|
Changes in pain
Zeitfenster: 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
|
|
Changes in resilience
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
18. Mai 2018
Primärer Abschluss (Tatsächlich)
1. März 2020
Studienabschluss (Tatsächlich)
1. März 2020
Studienanmeldedaten
Zuerst eingereicht
17. April 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Mai 2018
Zuerst gepostet (Tatsächlich)
15. Mai 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. März 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. März 2020
Zuletzt verifiziert
1. März 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 9969 (Andere Kennung: Fred Hutch/University of Washington Cancer Consortium)
- P30CA015704 (US NIH Stipendium/Vertrag)
- NCI-2018-00541 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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