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

Development and Pilot Testing of a Hybrid In Person and mHealth Coping Skills Training Intervention for Symptom Management and Daily Steps in Stem Cell Transplant Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03859765

Acronym

Symptoms-Steps

Enrollment

Registered

2019-03-01

Start date

2019-07-23

Completion date

2021-12-20

Last updated

2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stem Cell Transplant

Keywords

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

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.

Interventions

BEHAVIORALHCT 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months	16 months (additional year granted due to COVID-19).	Feasibility will be shown by meeting targeted study accrual (N=40) in the 16-month study period.
Number of Participants Who Adhere to at Least 80% of the Study Protocol	approximately 20-24 weeks	A measure of feasibility.
Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment	approximately 20-24 weeks	A measure of feasibility.
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) 8-item Version	post-treatment (approximately 7-12 weeks)	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).

Secondary

Measure	Time frame	Description
Change in Depression	pre-treatment (baseline), post-treatment (approximately 7-12 weeks)	Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). Each question rated 0-3, totaling 21 points.Total score of 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.
Change in Physical Disability as Measured by the the Functional Assessment of Cancer Therapy (FACT)	pre-treatment (baseline), post-treatment (approximately 7-12 weeks)	Physical Disability will be assessed using the Functional Assessment of Cancer Therapy 7-item physical well-being scale. Each item is scored 0=not at all to 4=very much as the statement applies to the past 7 days. The full range of the scale is 0 to 28, with a higher score indicating a better outcome.
Change in Self-Efficacy	pre-treatment (baseline), post-treatment (approximately 7-12 weeks)	Change in self-efficacy as measured by the Self-Efficacy for Symptom Management scale: 1=not at all confident to 10=totally confident.
Change in Anxiety.	pre-treatment (baseline), post-treatment (approximately 7-12 weeks)	Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS). Each question rated 0-3, totaling 21 points.Total score of 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.
Change in Pain Severity	pre-treatment (baseline), post-treatment (approximately 7-12 weeks).	Pain severity will be assessed with the Brief Pain Inventory (BPI). Patients will rate their pain right now, worst, least and average pain in the last week from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.
Change in Fatigue	pre-treatment (baseline), post-treatment (approximately 7-12 weeks).	Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) seven-item Fatigue Scale. For each item, the statement applies to the past 7 days: never (1), rarely (2), sometimes (3), often (4), or always (5). The summed score is then converted to a T-Score (0-100), where a higher T-Score indicates worse fatigue. 50 indicates the population mean with a standard deviation of 10. 50 and below is considered below average, 50-60 is mild, and 60 or greater is moderate/severe.
Change in Physical Activity	pre-treatment (baseline), post-treatment (approximately 7-12 weeks).	Physical Activity will be assessed via step count with a wireless activity tracker (e.g., Fitbit). A distinct value pre and post treatment are reported, no averages were taken across multiple days.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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.	20
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.	20
Total	40

Baseline characteristics

Characteristic	Total	HCT Education	HCT Symptoms and Steps
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	15 Participants	6 Participants	9 Participants
Age, Categorical Between 18 and 65 years	25 Participants	14 Participants	11 Participants
Age, Continuous	59.32 years STANDARD_DEVIATION 10.94	58.5 years STANDARD_DEVIATION 10.96	60.59 years STANDARD_DEVIATION 11.04
Cancer Type Lymphoma	6 Participants	5 Participants	1 Participants
Cancer Type Multiple Myeloma	31 Participants	14 Participants	17 Participants
Cancer Type Other	3 Participants	1 Participants	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants	17 Participants	19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants	2 Participants	1 Participants
First cancer or recurrence First Cancer	30 Participants	13 Participants	17 Participants
First cancer or recurrence Recurrence	10 Participants	7 Participants	3 Participants
Number of participants receiving anti-cancer drug	5 Participants	2 Participants	3 Participants
Number of participants receiving chemotherapy	15 Participants	8 Participants	7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	9 Participants	3 Participants	6 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	3 Participants	0 Participants
Race (NIH/OMB) White	28 Participants	14 Participants	14 Participants
Region of Enrollment United States	40 Participants	20 Participants	20 Participants
Sex: Female, Male Female	17 Participants	7 Participants	10 Participants
Sex: Female, Male Male	23 Participants	13 Participants	10 Participants
Time since diagnosis (months)	26.16 Months STANDARD_DEVIATION 50.73	18.86 Months STANDARD_DEVIATION 30.6	33.46 Months STANDARD_DEVIATION 65.08
Time since transplant (days)	19.65 Days STANDARD_DEVIATION 32.33	14.20 Days STANDARD_DEVIATION 10.98	25.10 Days STANDARD_DEVIATION 44.3

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20
other Total, other adverse events	0 / 20	0 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

Primary

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).

Time frame: post-treatment (approximately 7-12 weeks)

Population: Only applicable to the HCT Symptoms and Steps arm. Data not collected on two participants.

Arm	Measure	Value (MEAN)	Dispersion
Screening	Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) 8-item Version	27.89 units on a scale	Standard Deviation 3.46

Primary

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.

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

Population: Total number screened

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Screening	Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months	Number Ineligible	28 Participants
Screening	Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months	Number Eligible but Declined	51 Participants
Screening	Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months	Number Eligible but Unable to Consent	4 Participants
Screening	Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months	Number Accrued	40 Participants

Primary

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

A measure of feasibility.

Time frame: approximately 20-24 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Screening	Number of Participants Who Adhere to at Least 80% of the Study Protocol	17 Participants
HCT Education	Number of Participants Who Adhere to at Least 80% of the Study Protocol	18 Participants

Primary

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

A measure of feasibility.

Time frame: approximately 20-24 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Screening	Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment	3 Participants
HCT Education	Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment	2 Participants

Secondary

Change in Anxiety.

Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS). Each question rated 0-3, totaling 21 points.Total score of 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.

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