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Positive Psychology Intervention to Improve Quality of Life in Stem Cell Transplant Survivors and Their Caregivers

2 mars 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

29

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Livskvalitetsbedömning
Sidostudier
Andra namn:
  • Livskvalitetsbedömning
Övrig: Undersökningsadministration
Sidostudier
Beteende: Booklet
Receive positive psychology manual
Andra namn:
  • Broschyr
Beteende: Exercise Intervention
Complete positive psychology exercises
Beteende: Telephone-Based Intervention
Participate in phone sessions
Experimentell: 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.
Övrig: Livskvalitetsbedömning
Sidostudier
Andra namn:
  • Livskvalitetsbedömning
Övrig: Undersökningsadministration
Sidostudier
Beteende: Booklet
Receive positive psychology manual
Andra namn:
  • Broschyr
Beteende: Exercise Intervention
Complete positive psychology exercises
Beteende: Telephone-Based Intervention
Participate in phone sessions

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Study enrollment rates
Tidsram: 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
Tidsram: Up to 8 weeks
Up to 8 weeks
Completeness of follow-up data collection
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Fred Hutchinson Cancer Center

Samarbetspartners

National Cancer Institute (NCI)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 maj 2018

Primärt slutförande (Faktisk)

1 mars 2020

Avslutad studie (Faktisk)

1 mars 2020

Studieregistreringsdatum

Först inskickad

17 april 2018

Först inskickad som uppfyllde QC-kriterierna

2 maj 2018

Första postat (Faktisk)

15 maj 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 mars 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 mars 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 9969 (Annan identifierare: Fred Hutch/University of Washington Cancer Consortium)
  • P30CA015704 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2018-00541 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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