Positive Psychology Intervention to Improve Quality of Life in Stem Cell Transplant Survivors and Their Caregivers
2. marts 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Washington
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Seattle, Washington, Forenede Stater, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
Hjælpestudier
Andre navne:
Hjælpestudier
Receive positive psychology manual
Andre navne:
Complete positive psychology exercises
Participate in phone sessions
|
|
Eksperimentel: 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.
|
Hjælpestudier
Andre navne:
Hjælpestudier
Receive positive psychology manual
Andre navne:
Complete positive psychology exercises
Participate in phone sessions
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Study enrollment rates
Tidsramme: 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
Tidsramme: Up to 8 weeks
|
Up to 8 weeks
|
|
|
Completeness of follow-up data collection
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. maj 2018
Primær færdiggørelse (Faktiske)
1. marts 2020
Studieafslutning (Faktiske)
1. marts 2020
Datoer for studieregistrering
Først indsendt
17. april 2018
Først indsendt, der opfyldte QC-kriterier
2. maj 2018
Først opslået (Faktiske)
15. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 9969 (Anden identifikator: Fred Hutch/University of Washington Cancer Consortium)
- P30CA015704 (U.S. NIH-bevilling/kontrakt)
- NCI-2018-00541 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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