Positive Psychology Intervention In HSCT

Randomized Trial of a Positive Psychology Intervention for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05147311

Acronym

PATH-3

Enrollment

Registered

2021-12-07

Start date

2021-11-17

Completion date

2023-08-28

Last updated

2024-07-30

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 main purpose of this research study is to determine if a positive psychology-based program in people who have received a stem cell transplant for blood cancer treatment is feasible and acceptable, and can help improve positive feelings, mood, quality of life, overall wellbeing and health. The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention (PATH), a novel 9-week phone-administered Positive psychological intervention (PPI).

Detailed description

Low levels of positive psychological well-being (PPWB) (e.g., optimism, positive affect) in allogeneic hematopoietic stem cell transplant (HSCT) recipients are common and have been associated with decreased quality of life, poorer immune response, and increased mortality. These poor health outcomes are likely mediated through deficits in health behaviors (e.g., medication adherence, physical activity), and indeed low PPWB has been prospectively associated with poorer adherence to diet, medication, and physical activity in other medical populations, independent of sociodemographic, medical comorbidity, and the ill effects of depression and anxiety. Positive psychological interventions (PPIs) could be used to promote PPWB in the allogeneic transplant population. Despite the successful and effective use of PPIs in medical populations to reduce distress, increase quality of life, and promote health behaviors, PPI have never been tested in allogeneic recipients. -This a single center randomized trial of the PATH intervention versus usual care in patients with hematologic malignancies undergoing HSCT. The research study procedures include screening for eligibility: * Participants will be randomized equally to the two arms using randomized permuted blocks of sizes two and four, with randomization stratified by presence/absence of graft-versus-host disease (GVHD), as allogeneic transplant recipients with GVHD have significantly different courses of recovery, QOL, and function post transplant. * Participant will be randomized into either: The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention (PATH), a novel 9-week phone-administered Positive psychological intervention (PPI) or usual care. It is expected that about 70 people will take part in this research study. The National Institute of Health (NIH), National Cancer Institute (NCI) is supporting this research study by providing funding for the research

Interventions

BEHAVIORALPositive 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Adult patients (≥ 18 years) with hematologic malignancies who have received allogeneic HSCT at Dana Farber Cancer Institute who are approaching 100-day post-transplant milestone. * Ability to speak, read and write English. * Access to a telephone.

Exclusion criteria

* Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study procedures assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS). * Medical conditions precluding interviews. * Patients undergoing HSCT for benign hematologic conditions. * Patients undergoing outpatient HSCT. * Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures. * Patients who are unable to verbally consent or are not yet adults (including infants, children, teenagers), pregnant women, or prisoners.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Acceptability Rate	9 weeks	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.
Mean Quality of Life Scores	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.

Other

Measure	Time frame	Description
Mean Depression Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Post-Traumatic Stress Disorder Checklist Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Optimism Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Fatigue Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Satisfaction Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Gratitude Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Flourishing Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Positive Affect Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Overall Physical Function Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.
Mean Anxiety Score	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration	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.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
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-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.	35
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.	35
Total	70

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	0	1
Overall Study	Declined survey	1	0
Overall Study	Did not complete survey	2	1
Overall Study	Patient too sick	1	2

Baseline characteristics

Characteristic	PATH Intervention	Usual Care Control	Total
Age, Continuous	57.5 years STANDARD_DEVIATION 12.5	56.1 years STANDARD_DEVIATION 14.9	56.8 years STANDARD_DEVIATION 13.7
Race/Ethnicity, Customized Race Asian/Asian background	3 Participants	1 Participants	4 Participants
Race/Ethnicity, Customized Race Black	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Race Native American/Indigenous	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Race White	31 Participants	33 Participants	64 Participants
Region of Enrollment United States	35 participants	35 participants	70 participants
Sex: Female, Male Female	22 Participants	13 Participants	35 Participants
Sex: Female, Male Male	13 Participants	22 Participants	35 Participants
Type of cancer Leukemia	23 Participants	25 Participants	48 Participants
Type of cancer Lymphoma	1 Participants	2 Participants	3 Participants
Type of cancer Myelodysplastic syndromes/myeloproliferative neoplasms	11 Participants	8 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 35	1 / 35
other Total, other adverse events	0 / 35	0 / 35
serious Total, serious adverse events	0 / 35	0 / 35

Outcome results

Primary

Feasibility Rate

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

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
PATH Intervention	Feasibility Rate	31 Participants

Secondary

Acceptability Rate

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.

Time frame: 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.

Arm	Measure	Group	Value (MEAN)
PATH Intervention	Acceptability Rate	Acceptability - Mean Ease Score	7.40 scores on a scale
PATH Intervention	Acceptability Rate	Acceptability - Mean Utility Score	8.23 scores on a scale

Secondary

Mean Quality of Life Scores

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.