In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients

NCT03960619 | Completed

• 1 other identifier: Pro00100451
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the feasibility, acceptability, and efficacy of a novel mHealth behavioral intervention to enable HCT patients to effectively cope with symptoms to improve their ability to engage in physical activity that can improve physical disability. Our interdisciplinary team (psychiatry, hematology/oncology, occupational therapy) proposes a single arm pilot trial (N=20) to test a hybrid in-person and mHealth (video-conferencing, symptoms/activity monitoring, personalized feedback via text) HCT Coping Skills Training for Symptom Management and Daily Steps (CST Step-Up) intervention. CST Step-Up will provide patients with coping skills training and activity coaching sessions to enhance their ability to cope with symptoms that interfere with activity.

Conditions

Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)

Outcome Measures

Primary Outcomes (4)

• Accrual as measured by number of participants recruited

  Accrual will be indicated by meeting the recruitment goal

  15 months

• Adherence as measured by completing all intervention sessions

  Adherence will be indicated by the proportion successfully completing intervention sessions

  15 months

• Attrition as measured by 80% participants completing the study.

  Attrition will be indicated by 80% of consented participants completing the study protocol.

  15 months

• Acceptability as measured by 80% participants reporting satisfaction with CST program

  Acceptability will be indicated by 80% of patients reporting satisfaction with CST Step-Up on the CSQ.

  15 months

Secondary Outcomes (6)

• Change in Physical Disability

  assessments at baseline (pre - treatment) and post-intervention at 3-months..

• Change in Fatigue

  assessments at baseline (pre-treatment) and post-intervention at 3-months.

• Change in Psychological Distress

  assessments at baseline (pre-treatment) and post-intervention at 3-months.

• Change in Self-Efficacy for Symptom Management: PROMIS Self-Efficacy for Managing Symptoms Short Form

  assessments at baseline (pre-treatment) and post-intervention at 3-months.

• Symptom Monitoring

  post-intervention at 3-months.

Study Arms (1)

in-person & mHealth coping skills training

EXPERIMENTAL

hybrid in-person and mHealth coping skills training and activity coaching intervention is to reduce physical disability and decrease pain, fatigue and stress while enhancing patients' abilities to cope with symptoms that interfere with activity.

Behavioral: coping skills training

Interventions

coping skills training BEHAVIORAL

We aim to test a combined coping skills training and activity coaching protocol that: first, is feasible and acceptable, and second, improves physical disability, as well as pain, fatigue, distress, and physical activity in HCT patients. We propose a novel intervention protocol that uses a hybrid in-person and mHealth intervention delivery model.

in-person & mHealth coping skills training

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergone hematopoietic stem cell transplant (HCT) due to an oncological disease (e.g., leukemia, lymphoma, multiple myeloma)
• being at least 18years old and
• life expectancy at least 12 months.

You may not qualify if:

• cognitive impairment (e.g., dementia) recorded in the chart or suspected by healthcare provider,
• presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff, and
• inability to converse in English

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke university health system

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Tamara J Somers, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: July 16, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

US (1)