Hematopoietic Cell Transplantation RecipientNCT03525106
Positive Psychology Intervention to Improve Quality of Life in Stem Cell Transplant Survivors and Their Caregivers
A study testing Booklet, Exercise Intervention and Quality-of-Life Assessment in people with Hematopoietic Cell Transplantation Recipient, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Cell Transplantation Recipient
- What is being tested?
- Booklet, Exercise Intervention and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- English as primary language
- At least 1 year after HCT
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Booklet, Exercise Intervention, Quality-of-Life Assessment, Survey Administration, Telephone-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BookletBehavioural
Also called Pamphlet
Receive positive psychology manual
Exercise InterventionBehavioural
Complete positive psychology exercises
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Participate in phone sessions
| Study group | Role | What they receive |
|---|---|---|
| Participants: Positive Psychology Intervention | Experimental | 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. Receives: Behavioral: Booklet; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
| Caregivers: Positive Psychology Intervention | Experimental | 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. Receives: Behavioral: Booklet; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study enrollment rates
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.
Measured: Up to 8 weeks
Positive psychology intervention completion rates
Measured: Up to 8 weeks
Completeness of follow-up data collection
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.
Measured: Up to 8 weeks
Changes in happiness after each exercise
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.
Measured: Baseline up to 8 weeks
Changes in optimism after each exercise
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.
Measured: Baseline up to 8 weeks
Changes in mental health
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.
Measured: Baseline up to 6 months after intervention ends
Changes in physical health
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.
Measured: Baseline up to 6 months after intervention ends
Changes in fatigue
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.
Measured: Baseline up to 6 months after intervention ends
Changes in pain
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.
Measured: Baseline up to 6 months after intervention ends
Changes in resilience
This will be assessed with the Connor Davidson resilience scale. Total scores range from 0-40 with higher scores reflecting great resilience.
Measured: Baseline up to 6 months after intervention ends
Changes in anxiety and depression
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.
Measured: Baseline up to 6 months after intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start18 May 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Cell Transplantation RecipientStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie Lee, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525106
- Sponsor's protocol ID
- 9969
- Other IDs
- NCI-2018-00541, 9969, P30CA015704
- Status last verified
- Mar 2020
- First submitted
- 17 Apr 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Positive Psychology Intervention for Hematopoietic Cell Transplant Survivors to Improve Quality of Life
- ClinicalTrials.gov ID
- NCT03525106
- Acronym / sponsor ID
- 9969
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 May 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants: Positive Psychology Intervention | Experimental | Behavioral: Booklet, Behavioral: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Survey Administration, Behavioral: Telephone-Based InterventionParticipants 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. |
| Caregivers: Positive Psychology Intervention | Experimental | Behavioral: Booklet, Behavioral: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Survey Administration, Behavioral: Telephone-Based InterventionCaregivers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- English as primary language
- At least 1 year after HCT
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BookletAlso: PamphletReceive positive psychology manual | Behavioural | Caregivers: Positive Psychology Intervention, Participants: Positive Psychology Intervention |
| Exercise InterventionComplete positive psychology exercises | Behavioural | Caregivers: Positive Psychology Intervention, Participants: Positive Psychology Intervention |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Caregivers: Positive Psychology Intervention, Participants: Positive Psychology Intervention |
| Survey AdministrationAncillary studies | Other | Caregivers: Positive Psychology Intervention, Participants: Positive Psychology Intervention |
| Telephone-Based InterventionParticipate in phone sessions | Behavioural | Caregivers: Positive Psychology Intervention, Participants: Positive Psychology Intervention |
Primary outcome
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.
Positive psychology intervention completion rates
Time frame: Up to 8 weeks
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Lee principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booklet, Exercise Intervention and Quality-of-Life Assessment in people with Hematopoietic Cell Transplantation Recipient, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study enrollment rates (time frame: Up to 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.