Trial Outcomes & Findings for Positive Psychology Intervention In HSCT (NCT NCT05147311)

NCT ID: NCT05147311

Last Updated: 2024-07-30

Results Overview

Feasibility was defined a \>75% of enrolled participants in the PATH group completing at least 6 of the 9 positive psychology sessions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 9 weeks
• Results posted on: 2024-07-30

Participant Flow

2 participants were not randomized: 1 did not complete baseline measures and 1 was no longer interested in the study.

Participant milestones

Measure	PATH Intervention Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-hematopoietic stem cell transplant (HSCT), participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control Participants in the Usual Care Control arm will receive regular social work assessments as part of hematopoietic stem cell transplant (HSCT) recovery and work does not focus on positive psychological well-being (PPWB) skill building or cognitive strategies.
Overall Study STARTED	35	35
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	PATH Intervention Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-hematopoietic stem cell transplant (HSCT), participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control Participants in the Usual Care Control arm will receive regular social work assessments as part of hematopoietic stem cell transplant (HSCT) recovery and work does not focus on positive psychological well-being (PPWB) skill building or cognitive strategies.
Overall Study Did not complete survey	2	1
Overall Study Patient too sick	1	2
Overall Study Death	0	1
Overall Study Declined survey	1	0

Baseline Characteristics

Positive Psychology Intervention In HSCT

Baseline characteristics by cohort

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.	Total n=70 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 12.5 • n=5 Participants	56.1 years STANDARD_DEVIATION 14.9 • n=7 Participants	56.8 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	22 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian/Asian background	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native American/Indigenous	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
Type of cancer Leukemia	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Type of cancer Lymphoma	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Type of cancer Myelodysplastic syndromes/myeloproliferative neoplasms	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 weeks

Population: For feasibility analysis based on % of participants who completed ≥6 of 9 sessions sessions, only participants who started the intervention were used. Of the 33 participants who started PATH, 31 (94%) completed ≥6 of 9 sessions.

Feasibility was defined a >75% of enrolled participants in the PATH group completing at least 6 of the 9 positive psychology sessions.

Outcome measures

Measure	PATH Intervention n=33 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Feasibility Rate	31 Participants	—

SECONDARY outcome

Timeframe: 9 weeks

Population: For the acceptability analysis (i.e., mean ease and mean utility analysis), the analysis population denominator was 33 participants in the PATH group. Only participants in the intervention arm provided data on ease and utility since it pertains to the intervention directly.

At the end of each weekly intervention session, acceptability was measured with weekly ratings of ease and utility of each positive psychology exercise with a 10-point Likert scale (0=very difficult/not helpful; 10=very easy/very helpful).

The mean ease and utility of each exercise was calculated.

Outcome measures

Measure	PATH Intervention n=33 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Acceptability Rate Acceptability - Mean Ease Score	7.40 scores on a scale Interval 6.87 to 7.92	—
Acceptability Rate Acceptability - Mean Utility Score	8.23 scores on a scale Interval 7.83 to 8.63	—

SECONDARY outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) to assess quality of life (QOL) by cohort. Each question is scored from 0 ("Not at all") to 4 ("Very Much"). Total Score range from 0 to 180. A higher score indicates better quality of life. A mean score will be presented for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Quality of Life Scores Baseline	99.84 score on a scale Interval 93.64 to 106.04	103.72 score on a scale Interval 97.52 to 109.92
Mean Quality of Life Scores Post-Intervention (Week 9)	107.02 score on a scale Interval 98.96 to 115.08	113.82 score on a scale Interval 105.67 to 121.97
Mean Quality of Life Scores Follow-Up (Week 18)	111.63 score on a scale Interval 103.77 to 119.48	109.06 score on a scale Interval 101.1 to 117.02

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

The Patient Reported Outcome Measurement Information System-Fatigue-8a (PROMIS-Fatigue-8a) questionnaire will be used to assess fatigue by cohort. The total score range is 0-40. A higher score indicates higher levels of fatigue. A mean score will be presented for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Fatigue Score Baseline	22.26 score on a scale Interval 19.69 to 24.84	21.04 score on a scale Interval 18.47 to 23.62
Mean Fatigue Score Post-intervention (Week 9)	10.63 score on a scale Interval 7.87 to 13.39	9.36 score on a scale Interval 6.62 to 12.1
Mean Fatigue Score Follow-up (Week 18)	10.92 score on a scale Interval 7.96 to 13.88	12.25 score on a scale Interval 9.18 to 15.31

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

A mean overall physical function score will be generated for each cohort using a 20-item Patient-Reported Outcomes Measurement Information System-Physical Function-20 (PROMIS-PF-20) with each item scored from 1 to 5. The total score range is 0 to 100. Higher scores indicate better physical function. A mean score will be presented for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Overall Physical Function Score Baseline	80.11 score on a scale Interval 77.02 to 83.21	84.01 score on a scale Interval 80.91 to 87.1
Mean Overall Physical Function Score Post-intervention (Week 9)	85.33 score on a scale Interval 81.32 to 89.33	87.07 score on a scale Interval 83.1 to 91.03
Mean Overall Physical Function Score Follow-up (Week 18)	87.29 score on a scale Interval 82.69 to 91.89	85.97 score on a scale Interval 81.26 to 90.69

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

The 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) was used to assess symptoms of anxiety in all study participants. The total score on the HADS-A subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression. The mean anxiety score will be reported for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Anxiety Score Post-intervention (Week 9)	3.54 score on a scale Interval 2.5 to 4.58	4.48 score on a scale Interval 3.45 to 5.51
Mean Anxiety Score Baseline	5.69 score on a scale Interval 4.5 to 6.88	5.20 score on a scale Interval 4.02 to 6.38
Mean Anxiety Score Follow-up (Week 18)	4.27 score on a scale Interval 3.0 to 5.55	5.40 score on a scale Interval 4.09 to 6.7

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

The 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) was used to assess symptoms of depression. The HADS-D consists of a four-point item response. Scores on the HADS-D subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression. The mean depression score will be reported for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Depression Score Baseline	5.32 score on a scale Interval 4.26 to 6.37	5.02 score on a scale Interval 3.98 to 6.07
Mean Depression Score Post-intervention (Week 9)	4.33 score on a scale Interval 3.19 to 5.47	3.63 score on a scale Interval 2.5 to 4.75
Mean Depression Score Follow-up (Week 18)	3.91 score on a scale Interval 2.6 to 5.22	4.65 score on a scale Interval 3.31 to 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

The 17-item Post-Traumatic Stress Disorder Checklist (PCL) was used to assess symptoms of post-traumatic stress according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1-5. The total overall score range is 17 to 85. A higher score indicates higher levels of PTSD. A mean score will be presented for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Post-Traumatic Stress Disorder Checklist Score Post-intervention (Week 9)	25.33 score on a scale Interval 22.65 to 28.02	25.06 score on a scale Interval 22.38 to 27.74
Mean Post-Traumatic Stress Disorder Checklist Score Follow-up (Week 18)	24.31 score on a scale Interval 21.48 to 27.14	27.39 score on a scale Interval 24.53 to 30.26
Mean Post-Traumatic Stress Disorder Checklist Score Baseline	26.69 score on a scale Interval 23.8 to 29.58	27.27 score on a scale Interval 24.36 to 30.19

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

The 7-item Life Orientation Test-Revised (LOT-R) will be used to measure dispositional (trait) optimism. Each item is scored from 1-5. The total overall score range is 5 to 35. Higher scores indicate greater optimism. A mean score will be reported for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Optimism Score Baseline	17.29 score on a scale Interval 15.46 to 19.11	17.57 score on a scale Interval 15.75 to 19.4
Mean Optimism Score Post-intervention (Week 9)	17.99 score on a scale Interval 16.16 to 19.81	18.41 score on a scale Interval 16.59 to 20.23
Mean Optimism Score Follow-up (Week 18)	19.56 score on a scale Interval 17.84 to 21.27	17.14 score on a scale Interval 15.39 to 18.89

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

The 10-item Positive and Negative Affect Schedule (PANAS) will be used to measure positive affect. Each item is scored from 1-5. The total score range is 0 to 50. Higher scores indicate greater positive and negative affect. A mean score will be reported for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Positive Affect Score Baseline	34.89 score on a scale Interval 32.42 to 37.36	35.54 score on a scale Interval 33.07 to 38.01
Mean Positive Affect Score Post-intervention (Week 9)	36.63 score on a scale Interval 33.22 to 40.03	39.01 score on a scale Interval 35.57 to 42.45
Mean Positive Affect Score Follow-up (Week 18)	37.82 score on a scale Interval 34.65 to 40.99	36.81 score on a scale Interval 33.55 to 40.07

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

Satisfaction will be measured by Satisfaction with Life Scale (SWLS). This 5 item questionnaire will measure satisfaction with life; higher scores indicate greater satisfaction with life. Each item is scored from 1-7; the total score ranges from 5-35. A mean score will be reported for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Satisfaction Score Baseline	23.29 score on a scale Interval 20.81 to 25.76	22.65 score on a scale Interval 20.15 to 25.14
Mean Satisfaction Score Post-intervention (Week 9)	22.99 score on a scale Interval 20.22 to 25.76	24.11 score on a scale Interval 21.32 to 26.91
Mean Satisfaction Score Follow-up (Week 18)	25.16 score on a scale Interval 22.81 to 27.51	23.14 score on a scale Interval 20.74 to 25.53

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

The 6-item Gratitude questionnaire (GQ-6) measures dispositional gratitude; higher scores indicate greater proneness to experience gratitude in daily life. Each item will be scored from 1-7; the entire questionnaire will be scored from 6-42. A mean score will be reported for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Gratitude Score Baseline	37.51 score on a scale Interval 36.09 to 38.94	37.83 score on a scale Interval 36.4 to 39.25
Mean Gratitude Score Post-intervention (Week 9)	37.82 score on a scale Interval 35.9 to 39.75	38.03 score on a scale Interval 36.09 to 39.97
Mean Gratitude Score Follow-up (Week 18)	38.60 score on a scale Interval 36.8 to 40.4	38.13 score on a scale Interval 36.29 to 39.96

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Population: Intention-to-treat principle was used for all randomized patients.

The 8-item Flourishing Scale measures a person's self-perceived success in critical areas such as engagement, relationships, self-esteem, meaning and purpose, and optimism; higher scores indicate having many psychological resources and strengths. Each item is scored from 1-7; the entire questionnaire is scored from 8-56. A mean score will be reported for each cohort.

Outcome measures

Measure	PATH Intervention n=35 Participants Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -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 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.	Usual Care Control n=35 Participants Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
Mean Flourishing Score Follow-up (Week 18)	52.30 score on a scale Interval 48.73 to 55.86	53.21 score on a scale Interval 49.59 to 56.84
Mean Flourishing Score Baseline	51.49 score on a scale Interval 48.9 to 54.07	51.77 score on a scale Interval 49.19 to 54.35
Mean Flourishing Score Post-intervention (Week 9)	52.02 score on a scale Interval 48.62 to 55.42	55.31 score on a scale Interval 51.88 to 58.73

Adverse Events

PATH Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hermioni Amonoo, Director of Well-Being and Cancer Research Program

Brigham and Women's Hospital

Phone: ‭(617) 525-7472‬

Email: hermioni_amonoo@dfci.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place