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

NCT ID: NCT03859765

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-23
• Study Completion Date: 2021-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HCT Symptoms and Steps

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.

Group Type: EXPERIMENTAL

HCT Symptoms and Steps

Intervention Type: 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 Education

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HCT Symptoms and Steps

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke Cancer Institute

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36476318 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00100321

Identifier Type: -

Identifier Source: org_study_id