Trial Outcomes & Findings for A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients (NCT NCT03654404)
NCT ID: NCT03654404
Last Updated: 2024-06-12
Results Overview
Feasibility will be measured by examining the number of completed exercises.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline - week 8 of intervention
Results posted on
2024-06-12
Participant Flow
Participant milestones
| Measure |
Positive Psychology
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
Positive Psychology
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Overall Study
Death
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1
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Overall Study
Lost to Follow-up
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2
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Overall Study
Withdrawal by Subject
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5
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Baseline Characteristics
A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
Baseline characteristics by cohort
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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19 Participants
n=5 Participants
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
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Age, Continuous
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52.6 years
STANDARD_DEVIATION 12.78 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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20 participants
n=5 Participants
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Optimism
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21.7 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline - week 8 of interventionFeasibility will be measured by examining the number of completed exercises.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Feasibility of Positive Psychology (PP) Intervention
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8.0 sessions completed out of 8 sessions
Standard Deviation 0
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PRIMARY outcome
Timeframe: Baseline - week 8 of interventionParticipants will provide ratings of ease of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = very difficult and 10 = very easy). Ratings from all 8 weeks were averaged.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Acceptability of Exercises: Ease Score
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8.0 score on a scale
Standard Deviation 2.7
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PRIMARY outcome
Timeframe: Baseline - week 8 of interventionParticipants will provide ratings of utility of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not helpful and 10 = very helpful). Ratings from all 8 weeks were averaged.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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Acceptability of Exercises: Utility Score
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8.4 score on a scale
Standard Deviation 1.9
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SECONDARY outcome
Timeframe: Change in score from baseline to 8 weeksThe positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illness, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Changes in PANAS Scores
Baseline
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35.17 score on a scale
Standard Deviation 5.67
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Changes in PANAS Scores
Week 8
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37.08 score on a scale
Standard Deviation 4.10
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SECONDARY outcome
Timeframe: Change in score from baseline to 8 weeksLife Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of dispositional optimism.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Changes in LOT-R Scores
Baseline
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18.75 score on a scale
Standard Deviation 3.98
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Changes in LOT-R Scores
Week 8
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19.50 score on a scale
Standard Deviation 3.55
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SECONDARY outcome
Timeframe: Change in score from baseline to 8 weeksThe Hospital Anxiety and Depression Scale (HADS), which consists of the HADS-depression subscale and HADS-anxiety subscale, is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically ill patients before and after the PP intervention. Both subscales consist of 7 items, and each item is scored on a 0-3 scale, 0 indicating no clinical severity or a lack of symptoms, and 3 indicating significant clinical severity or increased symptom frequency; the maximum score is for each scale 21 and the minimum score is a 0. Higher scores indicate higher levels of depression or anxiety.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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Changes in HADS Scores
HADS-D Baseline
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6.58 score on a scale
Standard Deviation 2.15
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Changes in HADS Scores
HADS-D Week 8
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6.00 score on a scale
Standard Deviation 2.00
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Changes in HADS Scores
HADS-A Baseline
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5.75 score on a scale
Standard Deviation 2.73
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Changes in HADS Scores
HADS-A Week 8
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5.08 score on a scale
Standard Deviation 3.20
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SECONDARY outcome
Timeframe: Change in score from baseline to 8 weeksThe Functional Assessment of Cancer Therapy - Bone Marrow Transplant is a 47-item measure of the quality of life in patients undergoing bone marrow transplants before and after the PP intervention. There are five subscales, each including 7 items and various score ranges: Physical Well-Being (0-28), Social/Family Well-Being (0-28), Emotional Well-Being (0-24), Functional Well-Being (0-28), and Transplant (0-40). Each item is scored on a 5-point Likert scale based on patient agreement with each statement: 0 for "not at all," 1 for "a little bit," 2 for "somewhat," 3 for "quite a bit," and 4 for "very much." In each subscale, add items together to get the sum, then the sum is multiplied by 7, and finally, the sum is divided by the number of items answered to obtain the subscale score. The Physical and Emotional subscales are reverse scored. The total score is the sum of the subscale total added together and ranges from 0-148. The higher the score, the better the quality of life.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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Changes in FACT-BMT Scores
Baseline
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107.91 score on a scale
Standard Deviation 15.31
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Changes in FACT-BMT Scores
Week 8
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110 score on a scale
Standard Deviation 18.31
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SECONDARY outcome
Timeframe: Change in score from baseline to 8 weeksThe Patient-Reported Outcomes Measurement Information System - Physical Function is a well-validated scale used to measure overall function before and after the PP intervention. The PROMIS-Fatigue is scored on a 5-point Likert scale based on how much the person filling out the questionnaire agrees with the statement or question. The minimum value is 1 indicating "not at all" and the maximum value is 5 indicating "very much". Higher scores indicate higher levels of fatigue. The PROMIS-PF scores range from 20-100, with 20 indicating lower or limited levels of physical functioning and 100 indicating no difficulty or higher levels of physical functioning.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Changes in PROMIS-PF-20 Scores
Baseline
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85.67 score on a scale
Standard Deviation 8.13
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Changes in PROMIS-PF-20 Scores
Week 8
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86.33 score on a scale
Standard Deviation 10.40
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SECONDARY outcome
Timeframe: Week 1 of intervention - Week 8 of interventionParticipants will provide ratings of their present level of optimism after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not optimistic and 10 = very optimistic). Ratings from all 8 weeks were averaged.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Immediate Impact of Exercises: Optimism Score
pre-exercise
|
8.0 score on a scale
Standard Deviation 1.8
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Immediate Impact of Exercises: Optimism Score
post-exercise
|
8.6 score on a scale
Standard Deviation 1.4
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SECONDARY outcome
Timeframe: Week 1 of intervention - Week 8 of interventionParticipants will provide ratings of their present level of positive affect after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not happy and 10 = very happy). Ratings from all 8 weeks were averaged.
Outcome measures
| Measure |
Positive Psychology
n=20 Participants
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Immediate Impact of Exercises: Positive Affect Score
pre-exercise
|
7.9 score on a scale
Standard Deviation 1.6
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Immediate Impact of Exercises: Positive Affect Score
post-exercise
|
8.5 score on a scale
Standard Deviation 1.5
|
Adverse Events
Positive Psychology
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Positive Psychology
n=20 participants at risk
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
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|---|---|
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Blood and lymphatic system disorders
Death due to complications related to hematopoietic stem cell transplantation
|
5.0%
1/20 • Number of events 1 • 8 weeks
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Other adverse events
Adverse event data not reported
Additional Information
Hermioni L. Amonoo, Director of Well-Being and Cancer Research Program
Dana-Farber Cancer Institute
Phone: 617-525-7472
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place