A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03654404

Enrollment

Registered

2018-08-31

Start date

2018-09-11

Completion date

2021-07-31

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Cancer, Hematologic Malignancy, Hematopoietic/Lymphoid Cancer

Keywords

Hematopoietic Stem Cell Transplant, Positive Psychology, Hematologic malignancy, Positive Psychological Intervention

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.

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 = 30). 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.

Interventions

BEHAVIORALPositive 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of Positive Psychology (PP) Intervention	Baseline - week 8 of intervention	Feasibility will be measured by examining the number of completed exercises.
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.
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHermioni Amonoo, MD, MPP, MPH

Brigham and Women's Hospital

Participant flow

Participants by arm

Arm	Count
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.	20
Total	20

Arm

Count

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.

Total

Baseline characteristics

Characteristic	Positive Psychology
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	1 Participants
Age, Categorical Between 18 and 65 years	19 Participants
Age, Continuous	52.6 years STANDARD_DEVIATION 12.78
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Optimism	21.7 units on a scale STANDARD_DEVIATION 5.1
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	20 Participants
Region of Enrollment United States	20 participants
Sex: Female, Male Female	10 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 20
other Total, other adverse events	0 / 20
serious Total, serious adverse events	1 / 20

Outcome results

Primary

Acceptability of Exercises: Ease Score

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.

Time frame: Baseline - week 8 of intervention

Arm	Measure	Value (MEAN)	Dispersion
Positive Psychology	Acceptability of Exercises: Ease Score	8.0 score on a scale	Standard Deviation 2.7

Primary

Acceptability of Exercises: Utility Score

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.

Time frame: Baseline - week 8 of intervention

Arm	Measure	Value (MEAN)	Dispersion
Positive Psychology	Acceptability of Exercises: Utility Score	8.4 score on a scale	Standard Deviation 1.9

Primary

Feasibility of Positive Psychology (PP) Intervention

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

Time frame: Baseline - week 8 of intervention

Arm	Measure	Value (MEAN)	Dispersion
Positive Psychology	Feasibility of Positive Psychology (PP) Intervention	8.0 sessions completed out of 8 sessions	Standard Deviation 0

Secondary

Changes in FACT-BMT Scores

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.