This pilot randomized control trial (RCT) will test a 12-week, multiple behavior intervention physical activity and stress management for survivors with early stage lung cancer (stages I-III) and their family members (1 survivor + 1 family member or friend = 1 dyad). The long-term goal of this research is to improve health outcomes for survivors of lung cancer and their family members.
The goals of the intervention, Breathe Easier, are symptom reduction (less breathlessness, less fatigue, less stress) and change in multiple behaviors (increase in stress management and increase in physical activity, and decrease tobacco use - if appropriate).
Our aim is: To conduct a 6-month, two-group, pilot randomized control trial intervention study with a pre- and post-test study design to estimate preliminary intervention effects on (a) reduction of symptoms (breathlessness, fatigue, and stress) in survivors of non small cell lung cancer (stages I-III) and family members or friends; (b) increase in physical activity behaviors immediately following the intervention and at 3-months; (c) increase in stress management strategies immediately following the intervention and at 3-months; (d) reduction in smoking behavior among participants who smoke tobacco products at study entry immediately following the intervention at 3-months.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
1. Education: Each survivor will receive a copy of "Facing Forward; Life After Cancer Treatment" (No. 18-2424, March 2018). Each family member or friend will receive "When Someone You Love is Being Treated for Cancer" (No. 14-5726, May 2014). Specific parts of booklets will be reviewed during the 15-minute/per participant telephone "chat".
2. Telephone "Chats": The primary purpose is study retention. After the first 12-week period ends the weekly chats will be tapered for 12 weeks.
3. One text message delivered weekly by telephone is a reminder of the day and time of the chat(s).
Tobacco Use Reduction: Many survivors of lung cancer struggle with nicotine addiction; smoking cessation and relapse prevention content will be made available to current smokers (The FOREVER FREE program - a free, twelve short booklet evidence-based resource created by the H. Lee Moffitt Cancer Center \& Research Institute at the University of South Florida).
interventionNames
Behavioral: Breathe Easier
type
EXPERIMENTAL
label
BE Intervention Group
description
1. The BE Manual is an educational resource for Managing Stress, Increasing Physical Activity (PA) and Stopping Smoking and Staying Smoke free.
2. A timed, weekly telephone counseling session (60 min./dyad max) will be recorded. The purpose is to provide social support with SMART goal setting, adherence monitoring, encouragement..
3. Breathing Exercises and Meditations are incorporated into the BE Manual and sent by a link via text messages.
4. A Texting Library provides additional education, support, and encouragement daily. There are 5 story lines: BE Active, BE Kind to Yourself, BE Supportive and BE Smoke free (offered to current smokers only). Stay Smoke free will be instituted once tobacco use has stopped.
5. Weekly Logs for tracking goals and progress with behavior changes (PA, breathing practices and meditations) and a pedometer are provided. After 12 weeks, the calls and texts will be tapered.
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
21 Years
Show eligibility criteria text
Vulnerable populations: Three groups (prisoners, pregnant women and unborn fetuses, and children) will not be included in this study because there may be unknown risks. Prisoners will be excluded because if a survivor or a family member were a current prisoner, it would be impractical to expect an individual to fully participate for 6 months.
Pregnant women and unborn fetuses will be excluded because there may be unknown risks.
Inclusion of adolescents and children: Adolescents and children will be excluded also because they are younger than the Inclusion Criteria requirement of 21 years of age. Strategies to obtain representation of children in this study would not be appropriate, as they do not get the disease. Also, they will be excluded from participating as family members.
Table 3. Inclusion and Exclusion Criteria
Inclusion Criteria: Survivors
* Completed primary treatment for localized NSCLC (stages I-III). Survivors receiving adjuvant therapy are eligible.
* Willing to use a cell phone capable of receiving text messages
* Willing to complete a 12-week, home-based intervention program that includes face-to-face and telephone interaction
* Willing to consider behavior change at this time
* A family member or friend is willing to participate who is at least 21 years old
* Able to speak and read English
* Capable of informed consent
* A health clearance form is signed by a health care provider prior to enrollment
Inclusion Criteria: Family Members or Friends
* Willing to use a cell phone capable of receiving text messages
* Willing to complete a 12-week, home-based intervention program that includes face-to-face and telephone interaction
* Willing to consider behavior change at this time
* Has an eligible family member willing to participate who is at least 21 years old
* Able to speak and read English
* Capable of informed consent
* A health clearance form signed by a health care provider prior to enrollment
Exclusion Criteria: Both
* A known diagnosis of advanced lung cancer (stage IV)
* Physical activity is not recommended
* A history of recurrent falls
* A substantial mobility impairment related to rheumatoid arthritis, cerebral palsy, muscular dystrophy, multiple sclerosis, paralysis, Parkinson's disease, stroke
References
Publications (80)
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interventionNames
Behavioral: Breathe Easier
Primary outcomes (17)
measure
Physical function behavior change
timeFrame
Daily for 6 months
description
Measured by self-reported step counting using a pedometer and documented on a daily log.
measure
Physical function behavior change
timeFrame
Pre-intervention (Baseline) and post 3-months
description
Objectively measured by wearing an Accelerometer (on the participant's wrist with a velcro band) for 7 days. Measures physical activity intensity (sedentary, light, moderate, vigorous, and very vigorous).
measure
Physical function behavior change
timeFrame
Pre-intervention (Baseline) and post 6-months
description
Objectively measured by wearing an Accelerometer (on the participant's wrist with a velcro band) for 7 days. Measures physical activity intensity (sedentary, light, moderate, vigorous, and very vigorous).
measure
Physical function behavior change
timeFrame
Pre-intervention (Baseline) and post 3-months
description
Objectively measured by a Six-minutes Walk Test.
Specifically measures physical activity/exercise tolerance. Score = distance traveled in 6 min. measured in meters.
measure
Physical function behavior change
timeFrame
Pre-intervention (Baseline) and post 6-months
description
Objectively measured by a Six-minutes Walk Test.
Specifically measures physical activity/exercise tolerance. Score = distance traveled in 6 min. measured in meters.
measure
Stress management behavior change
timeFrame
Daily for 6 months
description
Measured by self-reported practice of breathing exercises documented on daily logs.
measure
Stress management behavior change
timeFrame
Daily for 6 months
description
Measured by self-reported meditation practice documented on daily logs.
measure
Change in the symptom of dyspnea
timeFrame
Pre-intervention (Baseline) and post 3-months
description
As measured by a validated instrument:
Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 1)
Measured by 10 items with a 4-point rating scale measuring shortness of breath (SOB) over the past 7 days (0 = not SOB; 1 = mildly SOB; 2= moderately SOB; 3 = severe SOB). Total score range 0 to 40. The higher the score measures worse SOB.
measure
Change in the symptom of dyspnea
timeFrame
Pre-intervention (Baseline) and post 6-months
description
As measured by a validated instrument:
Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 1)
Measured by 10 items with a 4-point rating scale measuring shortness of breath (SOB) over the past 7 days (0 = not SOB; 1 = mildly SOB; 2= moderately SOB; 3 = severe SOB). Total score range 0 to 40. The higher the score measures worse SOB.
measure
Change in the symptom of dyspnea
timeFrame
Pre-intervention (Baseline) and post 3-months
description
As measured by a validated instrument:
Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 2).
Measured by 10 items with a 4-point rating scale measuring functional limitations due to shortness of breath (SOB) over the past 7 days (0 = no difficulty, 1 = little difficulty; 2= some difficulty; 3 = much difficulty). Total score range 0 to 40. The higher the score measures greater functional difficulty due to SOB.
measure
Change in the symptom of dyspnea
timeFrame
Pre-intervention (Baseline) and post 6-months
description
As measured by a validated instrument:
Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 2).
Measured by 10 items with a 4-point rating scale measuring functional limitations due to shortness of breath (SOB) over the past 7 days (0 = no difficulty, 1 = little difficulty; 2= some difficulty; 3 = much difficulty). Total score range 0 to 40. The higher the score measures greater functional difficulty due to SOB.
measure
Change in the symptom of breathlessness
timeFrame
Pre-intervention (Baseline) and post 3-months
description
As measured by validated instrument:
Modified Medical Research Council - Dyspnea (mMRC) measures respiratory disability.
1 item measures perceived breathlessness. There are 5 statements describing respiratory disability. Scores range from 1 to 5. No disability = "I only get breathless with strenuous exercise" (Grade 1) to "I am too breathless to leave the house" (Grade 5). The higher the score the greater the disability.
measure
Change in the symptom of breathlessness
timeFrame
Pre-intervention (Baseline) and post 6-months
description
As measured by validated instrument:
Modified Medical Research Council - Dyspnea (mMRC) measures respiratory disability.
1 item measures perceived breathlessness. There are 5 statements describing respiratory disability. Scores range from 1 to 5. No disability = "I only get breathless with strenuous exercise" (Grade 1) to "I am too breathless to leave the house" (Grade 5). The higher the score the greater the disability.
measure
Change in the symptom of fatigue
timeFrame
Pre-intervention (Baseline) and post 3-months
description
As measured by a validated instrument:
Functional Assessment of Chronic Illness Therapy Scale (FACIT)-Fatigue (V.4) measures fatigue.
Measured by 13-items with a 4-point rating scale (4 = not fatigued at all; 0 = very much fatigued). Score range is 6 to 52. The higher the score the less fatigue.
measure
Change in the symptom of fatigue
timeFrame
Pre-intervention (Baseline) and post 6-months
description
As measured by a validated instrument:
Functional Assessment of Chronic Illness Therapy Scale (FACIT)-Fatigue (V.4) measures fatigue.
Measured by 13-items with a 4-point rating scale (4 = not fatigued at all; 0 = very much fatigued). Score range is 6 to 52. The higher the score the less fatigue.
measure
Change in perceived stress
timeFrame
Pre-intervention (Baseline) and post 3-months
description
As measured by a validated instrument:
Perceived Stress Scale measures perceived stress using a 10-item scale. There are 5 response items (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Score ranges from 0 to 40. The higher the score the greater perceived stress.
measure
Change in perceived stress
timeFrame
Pre-intervention (Baseline) and post 6-months
description
As measured by a validated instrument:
Perceived Stress Scale measures perceived stress using a 10-item scale. There are 5 response items (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Score ranges from 0 to 40. The higher the score the greater perceived stress.
Secondary outcomes (6)
measure
Tobacco use abstinence
timeFrame
Pre-intervention (Baseline) and post 3-months
description
Abstinence since quit date (score options yes/no)
measure
Tobacco use abstinence
timeFrame
Pre-intervention (Baseline) and post 6-months
description
Abstinence since quit date (score options yes/no)
measure
Tobacco use abstinence
timeFrame
Pre-intervention (Baseline) and post 3-month
description
Number of days without smoking in previous 7 days (score options: 0 to 7 days) will be measured by self report. The greater the number the greater daily abstinence.
measure
Tobacco use abstinence
timeFrame
Pre-intervention (Baseline) and post 6-months
description
Number of days without smoking in previous 7 days (score options: 0 to 7 days) will be measured by self report. The greater the number the greater daily abstinence.
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measure
Tobacco use abstinence
timeFrame
Pre-intervention (Baseline) and post 3-months
description
Saliva cotinine analysis: immune-chromatographic assay that quantifies cotinine (a major metabolite of nicotine with a relatively long half-life \[10-40 hr\]) will verify tobacco abstinence. Results will be reported as \_\_\_ng/ml. Result interpretations will be guided by https://salimetrics.com/guidelines-for-interpreting-cotinine-levels-united-states.
measure
Tobacco use abstinence
timeFrame
Pre-intervention (Baseline) and post 6-months
description
Saliva cotinine analysis: immune-chromatographic assay that quantifies cotinine (a major metabolite of nicotine with a relatively long half-life \[10-40 hr\]) will verify tobacco abstinence. Results will be reported as \_\_\_ng/ml. Result interpretations will be guided by https://salimetrics.com/guidelines-for-interpreting-cotinine-levels-united-states.