Trial Outcomes & Findings for Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer (NCT NCT03089125)

Results Overview

Compare the difference between study groups in the Modified Medical Research Council Dyspnea Scale severity score at 8 weeks. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

247 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians	Dyspnea Intervention Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness Dyspnea Intervention: Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians
Overall Study STARTED	121	126
Overall Study COMPLETED	99	94
Overall Study NOT COMPLETED	22	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

6 participants in the Usual Care Group and 9 participants in the Dyspnea Intervention Group did not complete the baseline Godin-Shephard Leisure Time Physical Activity Questionnaire.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=121 Participants Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians	Dyspnea Intervention n=126 Participants Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness Dyspnea Intervention: Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians	Total n=247 Participants Total of all reporting groups
Age, Continuous	65.44 years STANDARD_DEVIATION 10.08 • n=121 Participants	66.83 years STANDARD_DEVIATION 11.47 • n=126 Participants	66.15 years STANDARD_DEVIATION 10.81 • n=247 Participants
Sex: Female, Male Female	70 Participants n=121 Participants	68 Participants n=126 Participants	138 Participants n=247 Participants
Sex: Female, Male Male	51 Participants n=121 Participants	58 Participants n=126 Participants	109 Participants n=247 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=121 Participants	3 Participants n=126 Participants	4 Participants n=247 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=121 Participants	117 Participants n=126 Participants	235 Participants n=247 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=121 Participants	6 Participants n=126 Participants	8 Participants n=247 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=121 Participants	0 Participants n=126 Participants	0 Participants n=247 Participants
Race (NIH/OMB) Asian	2 Participants n=121 Participants	6 Participants n=126 Participants	8 Participants n=247 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=121 Participants	0 Participants n=126 Participants	0 Participants n=247 Participants
Race (NIH/OMB) Black or African American	2 Participants n=121 Participants	5 Participants n=126 Participants	7 Participants n=247 Participants
Race (NIH/OMB) White	113 Participants n=121 Participants	110 Participants n=126 Participants	223 Participants n=247 Participants
Race (NIH/OMB) More than one race	2 Participants n=121 Participants	4 Participants n=126 Participants	6 Participants n=247 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=121 Participants	1 Participants n=126 Participants	3 Participants n=247 Participants
Region of Enrollment United States	121 participants n=121 Participants	126 participants n=126 Participants	247 participants n=247 Participants
Modified Medical Research Council Dyspnea Scale (mMRCDS)	2.60 units on a scale STANDARD_DEVIATION 0.75 • n=121 Participants	2.59 units on a scale STANDARD_DEVIATION 0.72 • n=126 Participants	2.60 units on a scale STANDARD_DEVIATION 0.73 • n=247 Participants
Cancer Dyspnoea Scale (CDS)	12.61 units on a scale STANDARD_DEVIATION 7.51 • n=121 Participants	11.13 units on a scale STANDARD_DEVIATION 6.51 • n=126 Participants	11.85 units on a scale STANDARD_DEVIATION 7.05 • n=247 Participants
Functional Assessment of Cancer Therapy - Lung (FACT-L)	87.23 units on a scale STANDARD_DEVIATION 16.36 • n=121 Participants	90.19 units on a scale STANDARD_DEVIATION 18.59 • n=126 Participants	88.74 units on a scale STANDARD_DEVIATION 17.56 • n=247 Participants
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale	6.68 units on a scale STANDARD_DEVIATION 3.76 • n=121 Participants	5.37 units on a scale STANDARD_DEVIATION 3.80 • n=126 Participants	6.01 units on a scale STANDARD_DEVIATION 3.83 • n=247 Participants
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale	6.40 units on a scale STANDARD_DEVIATION 3.16 • n=121 Participants	5.73 units on a scale STANDARD_DEVIATION 3.72 • n=126 Participants	6.06 units on a scale STANDARD_DEVIATION 3.47 • n=247 Participants
Godin-Shephard Leisure Time Physical Activity Questionnaire	11.19 units on a scale STANDARD_DEVIATION 18.20 • n=115 Participants • 6 participants in the Usual Care Group and 9 participants in the Dyspnea Intervention Group did not complete the baseline Godin-Shephard Leisure Time Physical Activity Questionnaire.	12.29 units on a scale STANDARD_DEVIATION 16.91 • n=117 Participants • 6 participants in the Usual Care Group and 9 participants in the Dyspnea Intervention Group did not complete the baseline Godin-Shephard Leisure Time Physical Activity Questionnaire.	11.75 units on a scale STANDARD_DEVIATION 17.53 • n=232 Participants • 6 participants in the Usual Care Group and 9 participants in the Dyspnea Intervention Group did not complete the baseline Godin-Shephard Leisure Time Physical Activity Questionnaire.
Actigraphy	50.48 Percent time spent immobile while awake STANDARD_DEVIATION 13.62 • n=84 Participants • 37 participants in the Usual Care Group and 37 participants in the Dyspnea Intervention Group did not have three consecutive days of actigraphy data at baseline.	47.61 Percent time spent immobile while awake STANDARD_DEVIATION 11.19 • n=89 Participants • 37 participants in the Usual Care Group and 37 participants in the Dyspnea Intervention Group did not have three consecutive days of actigraphy data at baseline.	49.00 Percent time spent immobile while awake STANDARD_DEVIATION 12.48 • n=173 Participants • 37 participants in the Usual Care Group and 37 participants in the Dyspnea Intervention Group did not have three consecutive days of actigraphy data at baseline.

PRIMARY outcome

Timeframe: 8 weeks

Population: Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring care.

Compare the difference between study groups in the Modified Medical Research Council Dyspnea Scale severity score at 8 weeks. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.

Outcome measures

Outcome measures
Measure	Usual Care n=98 Participants Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians	Dyspnea Intervention n=92 Participants Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness Dyspnea Intervention: Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians
Modified Medical Research Council Dyspnea Scale (mMRCDS)	1.88 units on a scale Interval 1.69 to 2.07	1.55 units on a scale Interval 1.35 to 1.75

PRIMARY outcome

Timeframe: 8 weeks

Population: Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring care.

Compare the difference between study groups in the Cancer Dyspnoea Scale scores at 8 weeks. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea.