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Completed

NCT Number: NCT03525106

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

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.

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Key information

Conditions

Hematopoietic Cell Transplantation Recipient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Booklet

Behavioral

Receive positive psychology manual

Other names: Pamphlet

Exercise Intervention

Behavioral

Complete positive psychology exercises

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Survey Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Participate in phone sessions

Primary outcomes

  1. Study enrollment rates

    Time frame: 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.

  2. Positive psychology intervention completion rates

    Time frame: Up to 8 weeks

  3. Completeness of follow-up data collection

    Time frame: 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.

  4. Changes in happiness after each exercise

    Time frame: 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.

  5. Changes in optimism after each exercise

    Time frame: 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.

  6. Changes in mental health

    Time frame: 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.

  7. Changes in physical health

    Time frame: 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.

  8. Changes in fatigue

    Time frame: 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.

  9. Changes in pain

    Time frame: 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.

  10. Changes in resilience

    Time frame: 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.

  11. Changes in anxiety and depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility of a Positive Psychology Intervention for Hematopoietic Cell Transplant Survivors to Improve Quality of Life

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 15, 2018
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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