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Completed

NCT Number: NCT05147311

Positive Psychology Intervention In HSCT

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).

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Key information

Conditions

Hematologic Malignancy Blood Cancer Hematologic Diseases Hematologic Neoplasms Hematopoietic/Lymphoid Cancer Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive Psychology intervention

Behavioral

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.

Primary outcomes

  1. Feasibility Rate

    Time frame: 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 outcomes

  1. Acceptability Rate

    Time frame: 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.

  2. Mean Quality of Life Scores

    Time frame: 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 outcomes

  1. Mean Fatigue Score

    Time frame: 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.

  2. Mean Overall Physical Function Score

    Time frame: 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.

  3. Mean Anxiety Score

    Time frame: 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.

  4. Mean Depression Score

    Time frame: 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.

  5. Mean Post-Traumatic Stress Disorder Checklist Score

    Time frame: 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.

  6. Mean Optimism Score

    Time frame: 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.

  7. Mean Positive Affect Score

    Time frame: 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.

  8. Mean Satisfaction Score

    Time frame: 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.

  9. Mean Gratitude Score

    Time frame: 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.

  10. Mean Flourishing Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: PATH-3

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2021
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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