In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients

NCT03859765 | Completed Results

• 1 other identifier: Pro00100321
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hematopoietic stem cell transplant (HCT) is an aggressive treatment for life-threatening cancers. HCT improves survival, but most HCT patients experience significant physical disability, which is exacerbated by persistent symptoms. Pain, fatigue, and psychological distress are the most prevalent and debilitating symptoms. HCT patients experience a significant increase in disability as their pain, fatigue, and distress increase. This disability and symptom burden interferes with patients' ability to engage in recommended physical activity that can improve disability, symptoms, and other outcomes. Disability and symptoms also complicate an already challenging recovery course; HCT patients return home, often far from their medical team, are restricted from normal activities and socially isolated. These disability, symptom and activity challenges increase the risk for post-transplant complications and may compromise life expectancy. Teaching HCT patients to cope with symptoms and activity is critical to helping them increase activity and reduce disability. Cognitive behavioral coping skills training protocols can enhance HCT patients' ability to cope with symptoms (pain, fatigue, distress) that interfere with physical activity. However, the application of these protocols to HCT patients is limited by in person sessions, delivery of sessions in a medical center setting, and/or lack of tailoring to HCT patients' specific needs. Mobile health (mHealth) technologies can improve and extend intervention strategies to cope with symptoms and physical activity upon return home. Behavioral intervention strategies are needed to enable HCT patients to effectively cope with symptoms to improve their ability to engage in physical activity that can improve physical disability. The investigators aim to develop and 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. Specifically, the investigators will develop and test an in-person and mHealth HCT Coping Skills Training for Symptom Management and Daily Steps (HCT Symptoms and Steps) intervention protocol. To do this, the investigators will develop a mobile app, conduct focus groups, complete user testing, and conduct a small randomized controlled trial (RCT) to examine feasibility, acceptability, and outcome patterns suggesting intervention efficacy of the developed HCT Symptoms and Steps protocol. Following the development phase of the study (i.e., focus groups), the investigators will conduct user testing with 10 cancer patients who have undergone HCT; all 10 patients will receive the HCT Symptoms and Steps intervention. Next, the investigators will randomly assign 40 cancer participants who have undergone HCT and report pain, fatigue and stress to receive either HCT Symptoms and Steps or HCT Education. The investigators will test whether HCT Symptoms and Steps is feasible and acceptable to HCT patients, and improves physical disability, as well as other important outcomes. The investigators expect that HCT Symptoms and Steps will be feasible and acceptable to HCT patients and, compared to HCT Education, will be more likely to lead to improvements in physical disability, as well as pain, fatigue, distress, physical activity, and self-efficacy for symptom management. The investigators' goal is to demonstrate the feasibility, acceptability, and positive impact of a hybrid in-person and mHealth coping skills training and activity coaching intervention that reduces physical disability by concurrently and synergistically decreasing symptom burden and increasing physical activity. This project has the potential to lead to future research that can redesign existing modes of behavioral intervention delivery, improve continuity and coordination of care, and ultimately enhance patient outcomes.

Conditions

Stem Cell Transplant

Keywords

physical disability; pain; fatigue; distress; physical activity; coping; mHealth; cancer; symptom management

Outcome Measures

Primary Outcomes (4)

• Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months

  Feasibility will be shown by meeting targeted study accrual (N=40) in the 16-month study period.

  16 months (additional year granted due to COVID-19).

• Number of Participants Who Adhere to at Least 80% of the Study Protocol

  A measure of feasibility.

  approximately 20-24 weeks

• Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment

  A measure of feasibility.

  approximately 20-24 weeks

• Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) 8-item Version

  This questionnaire contains 8 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to sum CSQ answers resulting in a score range from 8 to 32. The intervention is considered acceptable if the mean value for acceptability across all participants is above 80% of max acceptability score (i.e., 25.6).

  post-treatment (approximately 7-12 weeks)

Secondary Outcomes (7)

• Change in Physical Disability as Measured by the the Functional Assessment of Cancer Therapy (FACT)

  pre-treatment (baseline), post-treatment (approximately 7-12 weeks)

• Change in Pain Severity

  pre-treatment (baseline), post-treatment (approximately 7-12 weeks).

• Change in Fatigue

  pre-treatment (baseline), post-treatment (approximately 7-12 weeks).

• Change in Physical Activity

  pre-treatment (baseline), post-treatment (approximately 7-12 weeks).

• Change in Depression

  pre-treatment (baseline), post-treatment (approximately 7-12 weeks)

Study Arms (2)

HCT Symptoms and Steps

EXPERIMENTAL

HCT Symptoms and Steps participants will complete in-person (3) and video-conferencing (4) coping skills training and activity coaching sessions teaching cognitive behavioral coping skills to manage pain, fatigue, and distress and increase activity. Participants will be given a wireless activity tracker and a smartphone for accessing the study mobile app.

Behavioral: HCT Symptoms and Steps

HCT Education

NO INTERVENTION

HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.

Interventions

HCT Symptoms and Steps BEHAVIORAL

HCT Symptoms and Steps will provide patients with cognitive behavioral coping skills training and activity coaching sessions to enhance their ability to manage symptoms that interfere with activity.

HCT Symptoms and Steps

Eligibility Criteria

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

You may qualify if:

• Hematopoietic stem cell transplant due to oncological disease
• Clinical ratings of pain, fatigue and psychological distress
• Life expectancy of 12 or more months

You may not qualify if:

• Cognitive impairment
• Severe psychiatric condition
• Inability to converse in English

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27701, United States

Location

Related Publications (1)

• Kelleher SA, Fisher HM, Hyland K, Miller SN, Amaden G, Diachina A, Pittman AS, Winger JG, Sung A, Berchuck S, Samsa G, Somers TJ. Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients undergoing hematopoietic stem cell transplant: Findings from intervention development and a pilot randomized trial. J Psychosoc Oncol. 2023;41(5):539-557. doi: 10.1080/07347332.2022.2152519. Epub 2022 Dec 8.

  PMID: 36476318 DERIVED

MeSH Terms

Conditions

Pain; Fatigue; Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Sarah A Kelleher, PhD
• Organization: Duke University

sarah.kelleher@duke.edu

919-416-3405

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 1, 2019
• Study Start: July 23, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2022-09

Locations

US (1)