PATH II: Development of a Positive Psychology Intervention to Improve Mood and HRQoL in Patients Post-HSCT - Proof of Concept

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03654404
Collaborator
Harvard Medical School (HMS and HSDM) (Other)
20
Enrollment
1
Location
1
Arm
34.6
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this research study is to find out if a novel phone-based positive psychology intervention that focuses on improving health behaviors and positive emotions can help improve mood, health related quality of life, and overall function in patients who have just undergone hematopoietic stem cell transplantation as part of blood cancer treatment.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Positive Psychology Intervention
N/A

Detailed Description

Hematopoietic stem cell transplantation (HSCT) is a rigorous treatment for blood cancer patients that can be life-saving, but often causes psychological distress. The investigators hope that this study will help the research team to develop and implement a positive psychological intervention designed to help HSCT patients increase positive emotions such as hope, gratitude, and fulfillment while recovering from a stem cell transplant. Participants will be selected after receiving an allogeneic hematopoietic stem cell transplant treatment in the past 30 days at the Dana-Farber Cancer Institute (DFCI).

In this project, the investigators hope to:
  1. Test the feasibility and acceptability of a novel, 8-week, phone-based positive psychology intervention in a small cohort of post-HSCT patients (N = 20).

  2. Explore potential benefits of completing the intervention on outcomes of interest, such as positive affect and overall function.

Baseline information about enrolled participants will be obtained from patients from the electronic medical record as required for characterization of our population. This information will include data regarding medical history, current medical variables, medications, and sociodemographic data.

Participants will be approached upon nearing their discharge from the hospital, approximately 30 days after their transplant. Between the time of their discharge and their 100-day post-transplant visit, there will be three check-in/psychosocial support phone calls at weeks 4, 8, and 12 after discharge to build rapport and discuss their recovery. Then, at week 14, participants will meet with the principal investigator to complete self-assessment questionnaires. The participants will then complete an 8-week phone-based positive psychology intervention, at the end of which the self-assessment questionnaires will be repeated.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Development of a Positive Psychology Intervention to Improve Mood and Health Related Quality of Life in Patients Post Hematopoietic Stem Cell Transplantation (PATH II)- Proof of Concept Trial
Actual Study Start Date :
Sep 11, 2018
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of Positive Psychology (PP) Intervention [Baseline - week 8 of intervention]

    Feasibility will be measured by examining the number of completed exercises.

  2. Acceptability of Exercises: Ease Score [Baseline - week 8 of intervention]

    Participants 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.

  3. Acceptability of Exercises: Utility Score [Baseline - week 8 of intervention]

    Participants 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.

Secondary Outcome Measures

  1. Changes in PANAS Scores [Change in score from baseline to 8 weeks]

    The 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.

  2. Changes in LOT-R Scores [Change in score from baseline to 8 weeks]

    Life 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.

  3. Changes in HADS Scores [Change in score from baseline to 8 weeks]

    The 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.

  4. Changes in FACT-BMT Scores [Change in score from baseline to 8 weeks]

    The 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.

  5. Changes in PROMIS-PF-20 Scores [Change in score from baseline to 8 weeks]

    The 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.

  6. Immediate Impact of Exercises: Optimism Score [Week 1 of intervention - Week 8 of intervention]

    Participants 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.

  7. Immediate Impact of Exercises: Positive Affect Score [Week 1 of intervention - Week 8 of intervention]

    Participants 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients with hematologic malignancies hospitalized for allogeneic HSCT at the DFCI inpatient units who are medically stable and appropriate for study approach

  • Ability to speak, read and write English

  • Access to a telephone

Exclusion Criteria:
  • Current major depressive episode, bipolar disorder, psychosis or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI)

  • Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study assessed via the Brief Interview for Mental Status (BIMS)

  • Medical conditions precluding interviews

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Dana Farber Cancer InstituteBostonMassachusettsUnited States02215

Sponsors and Collaborators

  • Dana-Farber Cancer Institute
  • Harvard Medical School (HMS and HSDM)

Investigators

  • Principal Investigator: Hermioni Lokko, MD, MPP, Dana-Farber Cancer Institute

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Hermioni Amonoo, MD, MPP, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT03654404
Other Study ID Numbers:
  • 18-225
First Posted:
Aug 31, 2018
Last Update Posted:
Jan 19, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hermioni Amonoo, MD, MPP, Principal Investigator, Dana-Farber Cancer Institute
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Period Title: Overall Study
STARTED20
COMPLETED12
NOT COMPLETED8

Baseline Characteristics

Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Overall Participants20
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
19
95%
>=65 years
1
5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
52.6
(12.78)
Sex: Female, Male (Count of Participants)
Female
10
50%
Male
10
50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
Not Hispanic or Latino
20
100%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
0
0%
White
20
100%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
20
100%
Optimism (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
21.7
(5.1)

Outcome Measures

1. Primary Outcome
TitleFeasibility of Positive Psychology (PP) Intervention
DescriptionFeasibility will be measured by examining the number of completed exercises.
Time FrameBaseline - week 8 of intervention

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
Mean (Standard Deviation) [sessions completed out of 8 sessions]
8.0
(0)
2. Primary Outcome
TitleAcceptability of Exercises: Ease Score
DescriptionParticipants 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.
Time FrameBaseline - week 8 of intervention

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
Mean (Standard Deviation) [score on a scale]
8.0
(2.7)
3. Primary Outcome
TitleAcceptability of Exercises: Utility Score
DescriptionParticipants 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.
Time FrameBaseline - week 8 of intervention

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
Mean (Standard Deviation) [score on a scale]
8.4
(1.9)
4. Secondary Outcome
TitleChanges in PANAS Scores
DescriptionThe 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.
Time FrameChange in score from baseline to 8 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
Baseline
35.17
(5.67)
Week 8
37.08
(4.10)
5. Secondary Outcome
TitleChanges in LOT-R Scores
DescriptionLife 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.
Time FrameChange in score from baseline to 8 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
Baseline
18.75
(3.98)
Week 8
19.50
(3.55)
6. Secondary Outcome
TitleChanges in HADS Scores
DescriptionThe 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.
Time FrameChange in score from baseline to 8 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
HADS-D Baseline
6.58
(2.15)
HADS-D Week 8
6.00
(2.00)
HADS-A Baseline
5.75
(2.73)
HADS-A Week 8
5.08
(3.20)
7. Secondary Outcome
TitleChanges in FACT-BMT Scores
DescriptionThe 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.
Time FrameChange in score from baseline to 8 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
Baseline
107.91
(15.31)
Week 8
110
(18.31)
8. Secondary Outcome
TitleChanges in PROMIS-PF-20 Scores
DescriptionThe 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.
Time FrameChange in score from baseline to 8 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
Baseline
85.67
(8.13)
Week 8
86.33
(10.40)
9. Secondary Outcome
TitleImmediate Impact of Exercises: Optimism Score
DescriptionParticipants 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.
Time FrameWeek 1 of intervention - Week 8 of intervention

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
pre-exercise
8.0
(1.8)
post-exercise
8.6
(1.4)
10. Secondary Outcome
TitleImmediate Impact of Exercises: Positive Affect Score
DescriptionParticipants 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.
Time FrameWeek 1 of intervention - Week 8 of intervention

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
Measure Participants20
pre-exercise
7.9
(1.6)
post-exercise
8.5
(1.5)

Adverse Events

Time Frame8 weeks
Adverse Event Reporting Description
Arm/Group TitlePositive Psychology
Arm/Group DescriptionParticipants 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.
All Cause Mortality
Positive Psychology
Affected / at Risk (%)# Events
Total1/20 (5%)
Serious Adverse Events
Positive Psychology
Affected / at Risk (%)# Events
Total1/20 (5%)
Blood and lymphatic system disorders
Death due to complications related to hematopoietic stem cell transplantation1/20 (5%) 1
Other (Not Including Serious) Adverse Events
Positive Psychology
Affected / at Risk (%)# Events
Total0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleHermioni L. Amonoo
OrganizationDana-Farber Cancer Institute
Phone617-732-6727
EmailHermioni_Amonoo@dfci.harvard.edu
Responsible Party:
Hermioni Amonoo, MD, MPP, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT03654404
Other Study ID Numbers:
  • 18-225
First Posted:
Aug 31, 2018
Last Update Posted:
Jan 19, 2022
Last Verified:
Dec 1, 2021